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We always have a number of studies running, many in need of participants. If you are interested in participating in our research, please see our lists of active research to learn more:
Smoking
Development of an Integrated mHealth App-Based Intervention to Support Smoking Cessation in People Living with HIV
Principal Investigators: Conall O’Cleirigh, PhD, Bettina Hoeppner, PhD
Funding Source: National Institute of Health (NIH)
Project Number: 1R21CA261458-01
Description: People with HIV who smoke lose more life-years to smoking than to HIV. Public health efforts to reduce the prevalence of smoking have under-served this important population, as demonstrated by the prevalence of smoking among persons living with HIV, which is more than twice as high compared to the general population. We propose to develop an integrated smoking cessation treatment that builds on our expertise and the field's successes in leveraging the HIV clinical care setting and smartphone app technology to provide scalable, tailored, sustained smoking cessation support to HIV-positive people who smoke.
Potential participants: Currently enrolling participants.
Effectiveness of a Smoking Cessation Algorithm Integrated into HIV Primary Care
Principal Investigators: Conall O’Cleirigh, PhD, Karen Cropsey, Ph.D., Heidi Crane, MD.
Funding Source: National Institute on Drug Abuse (NIDA)
Project Number: R01DA044112
Smoking remains the leading cause of preventable death and disability in the United States. Whereas smoking has declined significantly among individuals such as people living with HIV/AIDS (PLWH) in whom smoking prevalence rates and result comorbidity rates remain high. Medical advances in the treatment of HIV have resulted in substantial increases in life expectancy among PLWH and as a consequence PLWH who smoke are now, more than ever, at heightened risk for tobacco-related illness and death. In fact, PLWH who smoke engaged in treatment lose more years of life due to smoking now than to HIV disease. Although PLWH who smoke engaged in HIV care typically see a medical provider every 4-6 months, smoking cessation treatment and referral is often not part of routine HIV care. While 94% of HIV treatment providers indicated that they would be willing to provide smoking cessation services to their patients, few have received training in how to provide smoking cessation services. With 7 first-line pharmacotherapies available for smoking cessation, development of algorithms to assist providers in selecting the most appropriate pharmacotherapy is an important but untested strategy to increase smoking cessation in PLWH.
The purpose of this study is to:
This project is being conducted at Fenway Community Health in Boston, MA, University of Alabama at Birmingham, and at University of Washington at Seattle.
Potential participants: Currently enrolling participants.
Principal Investigators: Conall O’Cleirigh, PhD, Michael Zvolensky, Ph.D., Jasper Smits, Ph.D.
Funding Source: National Institute on Drug Abuse (NIDA)
Project Number: R01DA047933
Although the prevalence of smoking has declined over the past 50 years, large disparities in tobacco use remain across several subgroups, particularly disadvantaged and health compromised populations. People with HIV who smoke represent a major health disparity population in the United States and the world more generally, and their unique healthcare needs are not being adequately addressed. For people living with HIV, smoking is related to poorer survival and among those who are adherent to their antiretroviral treatment regimens, smoking reduces life expectancy more than HIV. Major contributing factors to maintenance and relapse of smoking among people with HIV who smoke include exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression.
The purpose of this study is to:
Potential participants: Currently enrolling participants.
Assessing the integration of tobacco cessation treatment into lung cancer screening (Screen ASSIST)
Principal Investigator: Elyse R. Park, PhD, MPH; Nancy A. Rigotti, MD; Jennifer S. Haas, MD, MSPH
Funding Source: National Cancer Institute (NCI)
Project Number: R01CA218123
Description: The randomized clinical factorial design trial offers tobacco cessation treatment to smokers having a lung cancer screening test. It is designed to help us meet the U.S. Preventive Services Task Force recommendation to offer smoking cessation as part of lung cancer screening. Screen ASSIST will identify current smokers who schedule a lung cancer screening test and offer them participation in a smoking cessation study. All study participants will receive evidence-based cessation treatment at no cost. The goal is to identify the most effective combination of (1) tobacco cessation counseling (4 vs. 8 sessions); (2) nicotine replacement (2 vs. 8 weeks); and referral to a community-based resource to address social stresses that make quitting difficult (referral vs. no referral). Smoking status (primary outcome) will be measured at 6-month follow-up.
Potential participants: Currently enrolling participants.
Implementing a virtual tobacco treatment in community oncology practices (Smoke Free Support Study 2.0)
Principal Investigator: Elyse R. Park, PhD, MPH; Jamie Ostroff, PhD
Funding Source: National Cancer Institute (NCI)
Project Number: 1R01CA214427-01A1
Description: The Smoke Free Support Study 2.0, or SSS2, is designed to examine the effectiveness and implementation of a virtually delivered, evidence-based tobacco treatment, in cancer care for patients in community oncology settings. SSS2 is designed to compare the effectiveness and implementation of an Enhanced Usual Care (EUC; control group) versus a Virtual Intervention Treatment (VIT; intervention group) for tobacco cessation in newly diagnosed cancer patients who smoke. Trial findings will establish the effectiveness and cost of utilizing a virtual strategy to deliver evidence-based tobacco treatment in community oncology settings and provide detailed initial data on implementation processes that will inform subsequent testing of multi-level implementation strategies for broad national dissemination into community cancer care settings.
Potential participants: Currently enrolling participants.
Integrating tobacco treatment into cancer care (Smoke Free Support Study)
Principal Investigator: Elyse R. Park, PhD, MPH
Funding Source: National Cancer Institute (NCI)
Project Number: 1K24 CA197381-01
Description: The mentoring and research aims of this proposal involve expanding our knowledge of how to develop and deliver evidence-based tobacco treatment for diverse/variety of cancer patients.
Potential participants: No longer recruiting.
Integrating tobacco treatment into cancer care (Smoke Free Support Study): Supplement to promote diversity in research
Principal Investigator: Elyse R. Park, PhD, MPH
Co-PI: Giselle K. Perez, PhD
Funding Source: National Cancer Institute (NCI)
Project Number: 3R01CA166147-03S1
Description: Although there is a clear need for tobacco treatment among black and Hispanic smokers, little is known about their smoking behaviors and engagement in tobacco treatment following a cancer diagnosis and initiation of cancer care. Understanding the contribution of racial and ethnic factors on tobacco treatment during cancer care will help inform the development of tobacco programs that target the needs of this group. The proposed supplement aims to understand attitudes and barriers toward tobacco cessation treatment among black and Hispanic cancer patients.
Potential participants: No longer recruiting.
Oncology
Principal Investigator: Allison Applebaum, PhD and Douglas Mennin, PhD
MGH Site Principal Investigator: Jamie Jacobs, PhD
Funding Source: National Cancer Institute (NCI)
Project Number: R01CA244185
Description: This is a multisite randomized controlled trial comparing Emotion Regulation Therapy to Traditional Cognitive Behavioral Therapy to reduce distress and burden in family and friend caregivers of patients undergoing treatment for varying cancer types and stages. Caregivers caring for patients with any type of cancer or any stage of disease are eligible to participate and will receive 8 free individual therapy sessions via videoconference. Patients are also eligible to complete surveys if their caregiver is enrolled in the trial. Enrollment is active.
Potential participants: We are recruiting informal caregivers to patients with any site/stage of cancer who have received any type of medical treatment (e.g. curative, palliative) at MGH in the past 12 months. Eligible caregivers are experiencing distress as evidenced by a score equal or above the study-specific cutoff on the Distress Thermometer (DT) and indicate that distress is associated with the caregiving experience. Interested patients or caregivers may contact Ali Wheeler for more information at caregivingresearch@mgh.harvard.edu.
Randomized trial of a multimodal sexual dysfunction intervention for hematopoietic stem cell transplant survivors
Principal Investigator: Areej El-Jawahri, MD
Co-investigator: Lara Traeger, PhD
Funding Source: American Cancer Society (ACS)
Description: This project entails conducting a single site randomized clinical trial to test the efficacy of a multimodal sexual dysfunction intervention to enhance sexual function, quality of life, and mood in hematopoietic stem cell transplant survivors.
Potential participants: Currently enrolling participants.
Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation
Principal Investigator: Ashley Nelson, PhD
Funding Source: National Heart, Lung, and Blood Institute
Project Number: 1K23HL159328-01
Description: The major goals of this project are to develop and test the feasibility and preliminary efficacy of a cognitive-behavioral intervention to reduce persistent fatigue following hematopoietic stem cell transplantation.
Potential participants: We are currently recruiting patients who completed autologous or allogeneic hematopoietic stem cell transplant for any hematologic condition and who are at least 6 months post-transplant and reporting moderate to severe fatigue.
For more information about this study contact: Katherine Cronin kgcronin@mgh.harvard.edu.
Psychological Intervention for Caregivers of Patients with Malignant Gliomas
Principal Investigator: Deborah Forst, MD
Co-investigator: Jamie Jacobs, PhD
Funding Source: Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO)
Description: This is a randomized controlled trial to examine the efficacy of a 6-session intervention based in cognitive behavioral therapy to reduce anxiety in caregivers of patients with malignant gliomas, in comparison with usual care. Caregivers of patients with malignant gliomas are eligible and will be randomly assigned to either the intervention (6 sessions with a therapist via videoconference) or a usual care control group.
Project Status: Recently completed; in data analysis.
Potential participants: No longer recruiting.
Intervention for Fear of Cancer Recurrence and Uncertainty in Survivorship (IN FOCUS)
Principal Investigator: Daniel L. Hall, PhD
Funding Source: National Center for Complementary and Integrative Health (NCCIH)
Project Number: K23At010157
Description: This is a 5-year study to adapt and pilot test a virtual, multimodal mind-body resiliency intervention (SMART-3RP) to help cancer survivors manage fear of recurrence (FOR). FOR is a common, highly distressing difficulty after diagnosis of a chronic and/or life threatening illness that may increase risk for poorer clinical outcomes by influencing healthcare engagement (e.g., frequency of follow-up screening). Among cancer survivors, a population growing in prevalence, clinically-impairing FOR is pervasive and can persist for years. Using qualitative and quantitative methods, this project will assess the feasibility and acceptability of an adapted mind-body intervention targeting FOR among cancer survivors and will inform the science of managing these fears and their clinical consequences among medical populations more broadly. Phase 1 of this study included focus groups and individual interviews with cancer survivors to identify targets for adaptation, including FOR-related coping and healthcare engagement patterns. Phase 2 will test the feasibility of the adapted intervention in a pilot RCT and will explore preliminary effects on FOR and healthcare engagement outcomes.
NCT.gov: https://clinicaltrials.gov/ct2/show/NCT04876599
Potential participants: No longer recruiting.
Survivorship Sleep Program (SSP): An Adapted Telehealth Intervention for Insomnia among Cancer Survivors
Principal Investigator: Daniel L. Hall, PhD
Funding Source: American Cancer Society (ACS)
Project Number: Institutional Research Grant
Description: This is a study to test the feasibility, acceptability, and preliminary effects of a synchronous, virtual cognitive behavioral therapy for insomnia (CBT-I) program for cancer survivors. Insomnia is a significant and often unaddressed problem for adults treated for various types of cancer, with a prevalence rate (30-50%) approximately three times as high as in the general population. CBT-I is a safe, highly effective, and affordable treatment for insomnia that may be delivered to patients in as few as four sessions; however, attrition is common, and engaging patients may require a patient-centered approach.
Using qualitative and quantitative methods, this project will seek to adapt CBT-I to address survivor late effects and unique sleep related concerns, via synchronous, virtual technology (e.g., Zoom). Phase 1 of this study included 10 individual interviews with cancer survivors with insomnia to identify perceived needs and preferences for virtually-delivered CBT-I. Phase 2 is testing the feasibility and preliminary efficacy of the Survivorship Sleep Program in a pilot RCT.
NCT.gov: https://www.clinicaltrials.gov/ct2/show/NCT04566068Potential participants: No longer recruiting.
INITIATE: Addressing Non-Initiation of Recommended Adjuvant Endocrine Therapy with a Culturally Informed Intervention
Principal Investigator: Jamie Jacobs, PhD
Funding Source: MGH ESSCO Breast Oncology
Description: The goal of this project is to develop and test a culturally-informed psychosocial intervention to increase initiation of adjuvant endocrine therapy in patients with early-stage, hormone receptor positive breast cancer and to improve equity in breast cancer care. This is a mixed methods study which will entail a qualitative phase with semi-structured interviews of Black, Latina, and Asian American patients who have not started adjuvant endocrine therapy and are hesitant to begin therapy. The second phase will involve a single arm pilot to test a 2-session virtual, culturally sensitive intervention to address barriers to starting endocrine therapy. The intervention will be led by a nurse practitioner in the Breast Oncology clinic.
Potential participants: We are recruiting women with Stage I-IIIB, ER+/PR+ breast cancer who have not yet started their recommended endocrine therapy (e.g., Tamoxifen, Arimidex, Aromasin, Femara, Faslodex, Zoladex) and are experiencing some hesitation about starting. To learn more about the study, please contact the study coordinator at sdatta12@mgh.harvard.edu or 617-643-8288.
Promoting adherence to endocrine therapy for breast cancer survivors
Principal Investigator: Jamie Jacobs, PhD
Funding Source: National Cancer Institute (NCI)
Project Number: 5K07CA211107-02
Description: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors) to reduce the risk of recurrence and improve survival; however, adherence to these medications among breast cancer survivors is overwhelmingly poor, with half of women being non-adherent within five years. Furthermore, breast cancer survivors with high psychological distress (e.g., related to side effects) are less likely to be adherent to this preventative treatment. There is an absence of efficacious interventions to improve endocrine therapy adherence, help survivors manage symptoms, and reduce distress. To address this gap, this study employs a mixed-methods design to develop and test a stepped-care, telehealth intervention to improve adherence to endocrine therapy and reduce distress in breast cancer survivors at Massachusetts General Hospital Cancer Center and three community affiliates. Step 1 is a 3-session, Brief Adherence Intervention for BCS with poor adherence; Step 2 is an adapted 8-session Cognitive-Behavioral Therapy for BCS with poor adherence and high distress. Phase 1 includes (1) intervention development with psychologists and oncology clinicians and semi-structured interviews with breast cancer survivors, and (2) a pilot study to evaluate acceptability and refine the intervention. Phase 2 will entail a randomized controlled trial to assess the feasibility of comparing the stepped-care, telehealth intervention to a medication monitoring control on adherence outcomes over eight months.
Potential participants: No longer recruiting.
STRIDE: Promoting adherence to endocrine therapy for breast cancer survivors
Principal investigator: Jamie Jacobs, PhD
Funding Source: National Cancer Institute (NCI)
Project Number: K07CA211107
Description: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors) to reduce the risk of recurrence and improve survival; however, adherence to these medications among breast cancer survivors is overwhelmingly poor, with half of women being non-adherent within five years. Furthermore, breast cancer survivors with high psychological distress (e.g., related to side effects) are less likely to be adherent to this preventative treatment. There is an absence of efficacious interventions to improve endocrine therapy adherence, help survivors manage symptoms, and reduce distress. To address this gap, this study employs an intervention, STRIDE (Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy), versus standard care plus medication monitoring in up to 100 breast cancer survivors taking adjuvant endocrine therapy (run-in period, n=5; RCT, n=100). Patients randomly assigned to the STRIDE intervention will receive six weekly one-hour sessions in small groups of two to three patients delivered via videoconferencing by a mental health professional. Patients assigned to the medication monitoring group will store their medication in the electronic pill bottle and receive oncology follow-up care as usual.
Project Status: Recently completed; in data analysis.
Potential participants: No longer recruiting.
Developing a couple-based intervention for young adults with cancer and their partner caregivers
Principal Investigator: Jamie Jacobs, PhD
Co-Investigator: Giselle Perez Lougee, PhD
Funding Source: American Cancer Society, Harvard Club of New York Foundation
Description: Young adult patients with cancer and their partner caregivers have unique unmet needs and specific challenges due to the timing of a cancer. The purpose of Phase 1 of this study is to gain a better understanding of the issues that are most distressing to young adult patients with cancer and their partner caregivers by conducting qualitative semi-structured interviews. We will collect feedback on the intervention delivery, timing, and content to develop the couple-based intervention. In Phase 2, we will refine and administer the intervention to help couples manage the stressors and challenges they may face as they navigate cancer treatment.
Potential participants: We are recruiting patients aged 25-39 that are in active treatment or have completed treatment within the past 1 year and their partner caregivers (spouses, partners, significant others) of any age. To learn more about the study, please contact the study coordinator at sdatta12@mgh.harvard.edu or 617-643-8288.
Exercise in Men with Prostate Cancer on Androgen Deprivation Therapy: A Qualitative Study
Principal Investigator: Daniel Lage, MD
Co-Investigator: Jamie Jacobs, PhD
Funding Source: Trefler Foundation: Trefler Cancer Care Equity Program
Description: The goal of this study is to understand barriers to uptake of exercise and healthy behaviors in men with prostate cancer on androgen deprivation therapy and develop an intervention to increase uptake of these behaviors. We will gather feedback through interviews with clinicians and patients with prostate cancer and their caregivers in order to develop a supportive care intervention that will address the challenges identified by this research in order to increase exercise, improve quality of life, and manage side effects in men with prostate cancer on ADT.
Potential participants: We are recruiting English or Spanish-speaking, Black and/or Hispanic or Latino patients with prostate cancer who are on androgen deprivation therapy and are planned to continue as of their last clinic visit.
Understanding and Improving Health Insurance Coverage Among Long-Term Follow-up Study Cohort Participants / HINT I
Principal Investigators: Elyse Park, PhD; Giselle Perez Lougee, PhD
Funding Source: American Cancer Society (ACS)
Project Number: RSGI-18-135-01
Description: Dr. Park and her colleagues published findings in the Journal of Clinical Oncology demonstrating that CCSS survivors, compared to siblings, were significantly more likely to be uninsured and to have difficulties obtaining health insurance. Given the current insurance landscape and the additional insurance burden that childhood cancer survivors face, the present study seeks to develop and pilot a health insurance navigation program targeted at feasibility and acceptability with survivors and improving health insurance literacy and ameliorating financial distress related to medical costs. The proposed health insurance navigation will involve 4 navigator-led health insurance navigation sessions. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.
Potential participants: No longer recruiting.
Assessing the Effect of Virtual Navigation Interventions to Improve Health Insurance Literacy and Decrease Financial Burden / HINT II
Principal Investigators: Elyse Park, PhD; Giselle Perez, PhD
Funding Source: American Cancer Society (ACS)
Project Number: 5 R01 CA271380
Description: We are conducting a Type I hybrid effectiveness-implementation trial to assess the effectiveness of HINT-S compared to enhanced usual care (EUC) in promoting health insurance literacy, thus reducing worry, unmet health care needs, and financial consequences due to medical costs to improve care and long-term outcomes of childhood cancer survivors. While this synchronous intervention is individualized, an asynchronous intervention may be more cost-effective and scalable. Thus, we will also compare HINT-S to HINT-A, a prerecorded, asynchronous version of the 5 HINT-S navigator sessions. Potential participants will complete an electronic screen, consent, and baseline survey and then will be randomized to one of three treatment arm (HINT-S, HINT-A, or EUC). All participants will complete surveys at baseline, 6, 12, and an 18-month follow-up and will receive $20 for each survey. A rigorous implementation evaluation will be conducted.
Potential participants: Currently enrolling participants.
Building Resiliency Among Caregivers of Curvivors and Metavivors: A Pilot randomized Trial
Principal Investigators: Elyse R. Park, Ph.D., MPH and Areej El-Jawahri, M.D.
Project Number: R21CA273785
Description: We will conduct a randomized trial of the SMART 3RP to intervene on 80 caregivers and cancer survivors (curvivors and metavivors) at the Massachusetts General Hospital Cancer Center (MGH). As caregiver and survivor stress can be synergistic and interdependent, we propose to intervene simultaneously, yet focus separately, on improving the resiliency of caregivers and survivors. We aim to determine the feasibility and acceptability of the SMART-3RP, based on the percent of survivor/caregivers who are eligible, enroll, complete the follow-up survey and attend 6/8 intervention sessions. Acceptability be assessed by treatment satisfaction (structure, delivery and content) reported via follow-up surveys and exit interviews. Our secondary aims are to determine the preliminary efficacy of the SMART-3RP for improving caregiver (primary) and survivor (secondary) resiliency as well as caregiver and survivor stress management and caregiver and survivor growth enhancement. We will also explore sociodemographic (e.g., gender, sex) and clinical characteristics (e.g., metavivor or curvivor) associated with intervention efficacy for caregivers and survivors and the effects of the SMART-3RP on caregivers’ and survivors’ health care utilization (e.g., hospitalizations, ED visits, surveillance, preventive services, and mental healthcare services).
Potential participants: Not yet recruiting.
Assessing the impact of health beliefs and psychological factors on lung cancer screening and intentions in urban and rural settings affected by COVID
Principal Investigators: Elyse R. Park, Ph.D. and Gina Kruse, M.D.
Funding Source: National Comprehensive Cancer Network (NCCN)
Description: The goal of this proposal is to assess the attitudinal and emotional impact of r21COVID-19 and vaccination status on patient willingness to complete lung cancer screening (LCS) in rural and urban settings. We will further explore patient- and provider-level barriers to LCS across two geographically diverse healthcare systems, as well as investigating whether the impact of the pandemic has further exacerbated existing health inequities in LCS behaviors.
Potential participants: Currently enrolling participants.
Using a Virtual Health Insurance Navigation Pilot Program to Understand and Improve Health Insurance Coverage Among Survivors of Colorectal Cancer / HINT-C
Principal Investigators: Elyse Park, PhD; Giselle Perez Lougee PhD
Description: This trial aims to assess the feasibility and acceptability of colorectal survivors approached and engaged in HINT and aims to assess the preliminary efficacy of HINT to improve 1) health insurance literacy and 2) financial burden related to medical cost concerns colorectal survivors. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the HINT intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.
Potential participants: Currently enrolling participants.
Developing a Mind-Body Intervention to Promote Sexual Well-Being of Female GI Cancer Survivors
Principal Investigator(s): Elyse Park, Ph.D., M.P.H.; Lucy Finkelstein Fox, Ph.D.
Funding Source: Osher Center for Integrative Medicine
Project Number: n/a
Description: Many female colorectal and anal cancer survivors experience changes to sexual well-being during and after treatment, including changes to body image, libido, and intimate relationships. The aim of this study is to develop a mind-body intervention to meet female colorectal and anal cancer survivors’ specific needs for sexual well-being. Focus groups with clinicians and interviews with cancer survivors will identify areas of unmet need and inform intervention development. Ultimately, we will conduct an open pilot trial to inform ongoing intervention refinement.
Potential Participants: Not yet open to recruitment.
A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors
Principal Investigator: Perez Lougee, PhD
Funding Source: National Cancer Institute (NCI)
Project Number: 1K07CA211955-01A1
Description: Survivors of cancers diagnosed during adolescence and young adulthood (AYA) represent a distinct group of survivors who are vulnerable to experiencing chronic stress and adverse health outcomes. Receiving a cancer diagnosis during a developmental period marked by peak socioemotional and physical changes has the potential to exacerbate typical adjustment problems and interfere with important age-specific milestones; despite their vulnerability, there are a lack of targeted programs to help AYAs manage these stressors. Using self-report and objective measures, this study proposes to develop and test the feasibility, acceptability and preliminary effects of an adapted, virtually delivered, evidence-based program, the Relaxation Response Resiliency Program (3RP),9 in promoting stress management and coping among survivors of AYA cancers.
Specific Aims: Using a 2-phase, mixed methods approach, we propose to:
Potential participants: No longer recruiting.
Exploring oncology providers’ attitudes toward cancer clinical trials
Principal Investigator: Giselle K. Perez, PhD
Funding Source: Lazarex-Mass General Cancer Care Equity Program
Project Number: NA
Description: Cancer clinical trials represent the “gold standard” of comparing and testing the safety and effectiveness of novel therapies for the treatment of cancer. Adequate participation of eligible populations is critical to ensuring the accuracy and generalizability of trial findings across diverse groups; however, trial enrollment rates remain suboptimal. The proposed study intends to expand this body of research by using mixed methods strategies to describe oncology providers’ perspectives of enrolling eligible patients into cancer clinical trials. Specifically, we aim to describe their attitudes, experiences, and barriers with recommending and enrolling patients into cancer clinical trials, purposely attending to concerns related to the enrollment of minority and underserved groups. In addition, this study aims to identify strategies to improve trial accrual rates. Findings will help guide the development of an educational intervention for cancer care providers to improve clinical trial enrollment among vulnerable and underserved populations.
Potential participants: No longer recruiting.
Promoting stress management and resiliency among lymphoma survivors transitioning off treatment
Principal Investigator: Perez Lougee, PhD
Funding Source: American Cancer Society (ACS)
Project Number: ACS IRG 2016S000828
Description: Lymphoma survivors are faced with a number of psychosocial and physical sequelae related to their cancer type and treatment that makes them susceptible to experiencing higher rates of distress compared to other survivor groups. This study proposes to develop and test a virtual group program to promote stress management and coping among lymphoma survivors transitioning off treatment.
Potential participants: No longer recruiting.
Enhancing quality of life in adults completing lung cancer treatment with curative intent
Principal Investigator: Lara Traeger, PhD
Funding Source: American Lung Association
Description: The goal of this project is to conduct a multi-site randomized clinical trial to test the efficacy of the Transitions Program, a behavioral intervention to improve quality of life in patients who have completed lung cancer treatment with curative intent. We aim to test the efficacy of the Transitions Program in improving patient-reported quality of life relative to the control group.
Potential participants: Currently enrolling participants.
To learn more about this study, please contact the study coordinator at: mscully@mgh.harvard.edu
HIV
Harvard University Center for AIDS Research (CFAR) Substance Use Scientific Working Group
Director: Abigail Batchelder, PhD, MPH
Description: This Scientific Working Group facilitates innovative and fruitful collaborations focused on substance use and HIV across the Harvard University CFAR (HU CFAR). While the role of substance use in the perpetuation of the HIV epidemic is well established in the literature, collaborations focused on substance use in the context of HIV treatment and prevention is underdeveloped at the HU CFAR. We accomplish the goal, this Scientific Working Group: 1) holds quarterly meetings; 2) produces and hosts cross-disciplinary symposiums focused on substance use HIV research; and 3) facilates structured mentorship opportunities focused on HIV and substance use. Additionally, we have an overarching anti-racism stance aiming to highlight, prioritize, and advocate for researchers and research collaborations that benefit black and indigenous people of color (BIPOC) given the historical inequities in responding to substance use in relation to HIV.
Potential participants: N/A
Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People with HIV who Inject Drugs
Principal Investigator: Abigail Batchelder, Ph.D., MPH
Funding Source: National Institute on Drug Abuse (NIDA)
Project Number: R34DA053686
Description: Recognizing that substance use is one of the most common predictors of antiretroviral therapy (ART) adherence and that people who inject drugs, specifically, demonstrate lower levels of ART adherence, this study pairs an app-based incentivize direct observation therapy (DOT) with a 1:1 stigma-focused cognitive-behavioral therapy (CBT) intervention, to examine its effects on ART adherence among people living with HIV who inject drugs. Our aim is to test the feasibility and acceptability of this stigma-focused intervention, while estimating its scalability via qualitative interviews with key informants, including collaborators at the Massachusetts Department of Public Health and community-based organizations.
Potential participants: Currently enrolling participants.
Status Neutral Psycho-Behavioral Capacity Building Intervention for People Who Use Drugs
Principal Investigator: Abigail Batchelder, Ph.D., MPH
Funding Source: This supplement was award through the Harvard University Center for AIDS Research (HU CFAR; NIH/NIAID 5P30AI060354-19) and is co-funded by NIA, NIDCR, NIGMS, NINR, NHLBI, NICHD, NIDA, NIDDK, NIMHD, NIMH, NCI, and the NIAID.
Description: This project aims to bring together clinical psychology researchers, leaders and staff from a local community-based organization which serves PWUD with and vulnerable to HIV (Victory Programs, Inc.), and people who use drugs (PWUD) to collaboratively select prioritized evidence-based brief interventions, optimize them for PWUD seeking services at Victory Programs, and make the optimized interventions available via a website and staff-training.
Potential Participants: Enrollment for this project is limited to staff, peer navigators, and individuals seeking services from Victory Programs, Inc.
Understanding and addressing internalized stigma and shame as barriers to engagement in HIV care (Project MATTER)
Principal Investigator: Abigail Batchelder, PhD, MPH
Funding Source: National Institute of Drug Abuse (NIDA)
Project Number: K23DA043418
Description: Internalized stigma and related emotions, such as shame, are under-addressed modifiable barriers to engagement in HIV care across the cascade, which theory indicates may mechanistically occur via avoidance coping behaviors, including substance use. As stigma-related emotions are notoriously under-reported, improved measurement and assessment of these pathways are needed to intervene on these barriers more strategically to HIV care. Building off of previous community-informed iterative intervention development work, this pilot randomized controlled trial (RCT) is designed to assess the feasibility and acceptability of the refined intervention among substance using HIV+ MSM with substance use disorders who are sub-optimally engaged in HIV care. Outcome data from this pilot will be used to assess the clinical utility for improving engagement in HIV care and reducing substance use.
Potential Participants: Currently enrolling participants. See https://fenwayhealth.org/studies/project-matter/
Principal Investigator: Abigail Batchelder, PhD, MPH
Funding Source: National Institute of Drug Abuse (NIDA)
Project Number: K23DA043418-04S1
Description: This administrative supplement supports ongoing community-based data collection and study operations related to the active pilot randomized controlled trial designed to improve engagement in HIV care by addressing internalized stigma and shame among sexual minority men with substance use disorders.
Addressing Internalized Stigma and Shame as Barriers to Engagement in HIV Care among Men who Have Sex with Men with Substance Use Disorders
Principal Investigator: Abigail Batchelder, Ph.D., M.P.H.
Funding Source: Claflin Distinguished Scholar Award, Executive Committee on Research (ECOR), MGH
Description: This award provides support for examining and intervening on internalized stigma and shame as barriers to engagement in HIV care among men who have sex with men with substance use disorders in the context of the Project MATTER intervention (K23DA043418).
Potential participants: N/A
Non-Verbal Measurement of Negative Self-Conscious Emotion
Principal Investigator: Abigail Batchelder, Ph.D., MPH
Funding Source: Osher Center for Integrative Medicine at Harvard University
Description: The internalization of stigma has been repeatedly associated with avoidance of self-care behaviors across populations, including people with stigmatized medical illnesses such as HIV. This pilot study involves the development and refinement of protocols for testing emotion using six measurement methods (postural movement, facial movement, autonomic stress response, vocal characteristics, narrative content, and self-reported emotion) in response to shame, frustration, and pride-evoking narrative induction tasks, as well as a rich battery of health-related outcomes. Ultimately, this measurement paradigm may serve as model for subsequent investigation among a more generalizable sample.
Potential Participants: Currently enrolling participants. See https://rally.massgeneralbrigham.org/study/one_time_study_emotions
Feasibility and Acceptability of a Cognitive Behavioral Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People with HIV (CHAMP)
Principal Investigator: Abigail Batchelder, Ph.D., MPH
Co-Investigator: Jacklyn Foley, Ph.D.
Funding Source: The Chong Jin Park Innovative Early Career Pilot Award in Aging and Palliative Care, MGH
Description: Evidence indicates that people aged 50 or older are disproportionately affected by age-related health disparities, attributable to chronic HIV immune activation and resulting inflammation. As psychological distress is also elevated among older people with HIV and exacerbates inflammation, the purpose of this intervention is to assess the feasibility and acceptability of an evidence-based cognitive behavioral therapy (CBT) group among older people with HIV as participants. This study additionally explores changes in inflammation biomarkers, psychological distress, and health risk behaviors in the intervention group versus an information-only control group. Ultimately, this study will propose an empirically supported model of the mechanisms linking CBT, psychological distress, inflammation, and age-related health in older people with HIV.
Potential Participants: Currently enrolling participants. See https://rally.massgeneralbrigham.org/study/champ
Prevention Navigator Expansion Initiative of Victory Programs’ Boston Living Center
Principal Investigator: Alyssa Collaro
Co-Investigator: Abigail Batchelder, Ph.D., M.P.H.
Funding Source: Substance Abuse and Mental Health Services (SAMHS) Projects of Regional and National Significance
Description: The primary purpose of this project is to provide and evaluate direct service expansion through Victory Programs’ Boston Living Center, a Boston-area nonprofit, to provide education and interventions to address substance misuse, HIV, and hepatitis prevention, and mental health challenges for racial/ethnic minority males and transgender individuals, as well as LGBTQ+ who are not in stable housing and live in communities with high incidences of HIV and viral hepatitis.
Potential Participants: Enrollment for this project is limited to individuals seeking services at the Boston Living Center.
Harvard University Center for AIDS Research (CFAR) Substance Use Scientific Working Group
Director: Abigail Batchelder, PhD, MPH
Funding Source: Harvard University CFAR (HU CFAR; NIH/NIAID 5P30AI060354-19)
Description: This Scientific Working Group facilitates innovative and fruitful collaborations focused on substance use and HIV across the Harvard University CFAR (HU CFAR). While the role of substance use in the perpetuation of the HIV epidemic is well established in the literature, collaborations focused on substance use in the context of HIV treatment and prevention is underdeveloped at the HU CFAR. We accomplish the goal, of this Scientific Working Group: 1) hold quarterly meetings; 2) produce and hosts cross-disciplinary symposiums focused on substance use HIV research, and 3) facilitate structured mentorship opportunities focused on HIV and substance use. Additionally, we have an overarching anti-racism stance aiming to highlight, prioritize, and advocate for researchers and research collaborations that benefit black and indigenous people of color (BIPOC) given the historical inequities in responding to substance use in relation to HIV
Potential Participants: NA
Examining Sexual Minority Engagement in Recovery Community Centers
Principal Investigator: Abigail Batchelder, Ph.D., MPH
Co-Investigators: Jillian Scheer, Ph.D., John Kelly, Ph.D., Bettina Hoeppner, Ph.D., MS
Funding Source: National Institute on Drug Abuse (NIDA)
Description: A more granular characterization of sexual minority individuals currently utilizing RCCs is needed to better understand how RCCs are serving sexual minority individuals. The purpose of this semi-structured qualitative interview study is to garner insights into perceived facilitators, barriers, and benefits of RCCs from sexual minority individuals may inform the design of more accessible, acceptable, and effective treatments for sexual minority individuals more broadly.
Potential Participants: No longer recruiting.
Mindfulness and Cardiovascular Health among People with HIV (MI-HHEART)
Principal Investigator: Jacklyn Foley, Ph.D.
Mentors: Abigail Batchelder, Ph.D., MPH, Conall O’Cleirigh, Ph.D., and Gloria Yeh, M.D., M.P.H.
Funding Source: Harvard University Center for AIDS Research (HU CFAR) Developmental Award
Description: People living with HIV (PLWH) are at greater risk of cardiovascular disease (CVD), in part, due to the influence of psychological distress on immune activation and CVD risk behaviors. Psychological distress, immune activation, and CVD risk behaviors have been successfully targeted with mindfulness practices; however, these associations have not been confirmed among PLWH. The purpose of this study is to inform the development of a CVD risk reduction intervention for PLWH that will include both qualitative and quantitative exploration of the possible benefit of including mindfulness and other participant-driven components. Participation involves completing quantitative self-report surveys, a blood draw for biological measurement, and qualitative focus group discussions.
Potential Participants: Currently enrolling participants. https://rally.massgeneralbrigham.org/study/mi_hheartquant; https://rally.massgeneralbrigham.org/study/mi_hheartqual
Identifying PrEP Use Facilitators and Barriers in People with Opioid Use Disorder
Principal Investigator: Matthew Sullivan, PhD
Co-Investigators: Abigail Batchelder, PhD, MPH; Conall O’Cleirigh, PhD; Christina Psaros, PhD
Funding source: HU CFAR Developmental Award: Bio-Behavioral and Community Science Research
Description: People with opioid use disorder (PWOUD) face elevated risk for HIV infection through both injection drug use and sexual risk. HIV pre-exposure prophylaxis (PrEP) holds the most promise of any available tool for containing the spread of HIV both domestically and worldwide. Yet, despite high awareness and willingness to use PrEP among people who inject drugs in treatment, oral PrEP uptake remains low. This study will enroll 120 adults with opioid use disorder (OUD) to complete a survey assessment to identify psychosocial and structural facilitators and barriers to PrEP uptake, and to determine the acceptability of oral and long-acting injectable formulations of PrEP. A subset of up to 30 participants will complete in-depth qualitative interviews assessing acceptable features of a PrEP support behavioral intervention. Consistent with the Theory of Planned Behavior, the study will examine PrEP attitudes, perceived norms concerning PrEP use, and perceived ability to obtain and adhere to PrEP as determinants of PrEP uptake intentions. We intend to extend the current literature by novelly investigating PrEP use intentions across the OUD treatment cascade. The study will also incorporate a behavioral measurement of PrEP intentions, employ quantitative as well as qualitative analysis, and examine acceptability of both oral and long-acting injectable formulations of PrEP. Results of this study will inform behavioral intervention development to support engagement in PrEP and HIV risk reduction among PWOUD.
Potential Participants: Recruitment is anticipated to start in winter 2022.
National HIV Behavioral Surveillance
Site Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: Centers for Disease Control and Prevention (CDC)
The purpose of National HIV Behavioral Surveillance (NHBS), which was created in 2003 by the Centers of Disease Control and Prevention, is to conduct behavioral surveillance among persons at high risk for HIV in 22 cities across the US. The study is run in 3 annual, rotating cycles, each of which aims to surveille a population at increased risk for HIV:
Since 2017, the Boston project site has been managed through a collaboration between the Massachusetts Department of Public Health and The Fenway Institute at Fenway Health.
Potential Participants: No longer recruiting.
The UNC/Emory Care Center for Innovative Technology (iTech) across the prevention and care continuum
(Sub-grant: An evidence-based cognitive behavioral adherence intervention to enhance PrEP uptake and adherence in high risk YMSM (Life Steps for Youth))
Principal Investigator: Christina Psaros, PhD & Kenneth Mayer, PhD (Project PIs); Lisa Hightow-Weidman & Patrick Sullivan (Overall PIs)
Funding Source: National Institute of Child Health and Human Development (NICHD)
Project Number: U19 HD089881-02S2
Description: The goal of this study is to refine the LifeSteps Intervention to meet the needs of young men who have sex with men who wish to use PrEP. We will then test the refined intervention in a pilot randomized controlled trial.
Potential participants: No longer recruiting
PrEP Demonstration Project Among Women at Risk for HIV Infection
Co-Principal Investigators: Christina Psaros and M. Kempf
Funding Source: National Institute of Mental Health (NIMH) / R34 MH118044
Description: In the proposed pilot implementation study, we will first conduct preliminary work to understand how to best implement PrEP services into FQHC clinics in Alabama. In the next phase, an existing protocol for PrEP delivery will be modified, implemented, and refined using an iterative process; provider and patient level data on adherence to the PrEP care continuum will be collected.
Potential participants: Currently enrolling participants.
Please contact ottcm@uab.edu for more information.
A qualitative ancillary study of HPTN 083
A phase 2b/3 double blind efficacy study of quarterly injectable cabotegravir compared to daily oral tenofovir/emtricitabine (Truvada), for PrEP in HIV uninfected MSM and transgender women
Protocol Chairs: Christina Psaros, PhD & Steve Safren, PhD
Funding Source: National Institute of Health (NIH)/ National Institute of Allergy and Infectious Diseases (NIAID) / National Institute of Mental Health (NIMH)
Project Number: HPTN 08320725
Description: The objective of this study is to (1) identify potential barriers, facilitators, and potentially modifiable issues related to adherence to clinic visits in the context of injectable PrEP; (2) learn about preferences and decision-making regarding the use of oral versus injectable PrEP, or other biomedical prevention products; and (3) gather explanatory qualitative data regarding participants’ experiences in HPTN 083 to better interpret study results and guide next step prevention strategies.
Potential participants: No longer recruiting.
Evaluation of Trial of Life-Steps to Enhance Adherence and Engagement in PrEP Care
Principal Investigators: S. Safren and K. Mayer
Co-Investigator: Christina Psaros
Funding Source: National Institute of Health (NIH) / R01 MH118043
Description: In the proposed study, the Life Steps intervention will be tested for efficacy in promoting PrEP adherence and maintenance. The primary outcome will be measure of adherence to daily PrEP over 12 months, and secondary outcomes will examine changes in sexual behavior, exploring the effectiveness of the intervention.
Potential participants: Currently enrolling participants.
Aging
Effect of COVID-19 in caregivers of persons with dementia
Principal Investigator: Christine Ritchie, MD, MSPH
Co-investigator: Lara Traeger, PhD
Funding Source: National Institute on Aging (NIA)
Project Number: 3R01AG050515-04S1
Description: The purpose of this study is to better understand the experience of caregivers caring for persons with dementia in assisted living facilities, nursing homes and in the community during the COVID-19 pandemic. We aim to: 1) describe the caregiver lived experience during the COVID-19 pandemic, 2) examine how COVID-19 related factors have affected caregiver stress, 3) explore the role of COVID-19 related factors on behavior changes and severity in persons living with dementia, and 4) assess the impact of COVID-19 on caregiver planning and health care decision-making.
Potential participants: No longer recruiting.
Enhancing Resilience in Senior Living Community Residents: A Randomized Controlled Trial
Principal Investigator: Lara Traeger, PhD
Funding Source: Davis Family Foundation
Description: Mind-body medicine offers key strategies to help older adults enhance their health, resilience and capacity to flourish. This multi-site randomized controlled trial is designed to test the efficacy of integrating a mind-body group program for improving resilience and flourishing among senior living communities. This study will be conducted in collaboration senior living communities across the U.S.
To learn more about this study, please contact the study coordinator at mscully@mgh.harvard.edu
Potential participants: No longer recruiting.
Understanding and improving surgical decision-making for persons living with dementia, their family caregivers role, and their providers: A mixed methods study
Principal Investigator: Joel Weissman, PhD
Co-investigator: Lara Traeger, PhD
Funding Source: National Institute on Aging (NIA)
Project Number: R01AG067507-01
Description: The goal of this study is to understand and improve surgical decision making in persons living with dementia. We aim to: 1) develop the evidence base to understand the case mix and comparative outcomes of surgery provided to people living with dementia, 2) characterize surgical decision-making in clinical settings for people living with dementia, and 3) develop recommendations around surgical decision-making processes.
Potential participants: Currently enrolling participants.
Weight Management and Physical Activity
Testing the feasibility and preliminary efficacy of a psychological and behavioral interventional to promote physical activity after weight loss
Principal Investigator: Emily Feig, PhD
Funding Source: National Heart Lung and Blood Institute (NHLBI)
Project Number: K23HL148017
Description: Physical activity is critical for maintaining health and preventing weight regain after bariatric surgery; however, most patients do not meet recommended levels of physical activity. The aim of this multiphase study is to develop and test a positive psychology-based telephone counseling intervention to increase physical activity in people who have recently had bariatric surgery. We completed a qualitative study to better understand the lived experiences of physical activity in this population which informed a proof-of-concept trial to refine the newly developed intervention. Now we are conducting a pilot randomized controlled trial of the refined intervention compared to a physical activity education control.
Potential participants: We are currently recruiting adults who have had bariatric surgery in the past 6-12 months and are interested in becoming more active.
Testing the feasibility of an intervention to promote physical activity for metabolic syndrome
Principal Investigator: Rachel Millstein, PhD
Funding Source: National Heart Lung and Blood Institute (NHLBI)
Project Number: K23HL135277
Description: Physical activity is critical for patients with metabolic syndrome, as it can prevent the risk of progressing to chronic diseases; however, most patients do not meet recommended levels of physical activity. This study aims to develop and test the feasibility of an 8-week physical activity intervention with targets of change at individual (positive psychology and motivational interviewing), social (group-based), and environmental (neighborhood walkability) levels of influence in patients with metabolic syndrome. If the intervention is successful, it can have the potential to improve health outcomes and prevent chronic diseases in this high-risk population.
Potential participants: We are recruiting individuals with a combination of high blood pressure, high blood sugar, high cholesterol or triglycerides, and high body weight, who speak English, do not do enough physical activity, and may benefit from learning skills to improve physical and emotional well-being. The program is takes place in groups of 4-8 people (total of up to 64 participants) and consists of eight weekly 90-minute sessions at local Mass General outpatient clinics.
For more information, please contact Sonia Kim (617-643-0871).
Sexual Minority Health
The daily effects of trauma and minority stress among sexual minority women with post-traumatic stress symptoms
Principal Investigators: Jillian Scheer
Co-Investigator: Abigail Batchelder, PhD, MPH
Funding Source: Yale Fund for Lesbian and Gay Studies (FLAGS)
Description: This study aims to understand the trajectory of minority stress among sexual minority women with posttraumatic stress symptoms using daily diaries.
Potential participants: No longer recruiting.
The Price of Minority Stress on Violence-exposed Sexual Minority Women’s Mental Health and Coping Strategies
Principal Investigators: Jillian Scheer
Co-Investigator: Abigail Batchelder, PhD, MPH
Funding Source: Women Faculty Forum Seed Grant
Description: This study aims to collect qualitative and quantitative data to develop an intervention for sexual minority women who have been exposed to violence.
Potential participants: No longer recruiting.
Gender Expression and Gender Identity of Sexual Minority Women in Relation to Health Behaviors
Principal Investigators: Abigail Batchelder, PhD, MPH
Co-Investigator: Jennifer Potter, M.D., Jenna Morris, M.D.
Funding Source: Fenway Health
Description: This web-based study assessed sexual minority women’s health behaviors in relation in relation to gender expression and validated psychological assessments of body satisfaction, minority stress, internalized sexism, and resilience.
Potential Participants: No longer recruiting.
Children with ASD/Special Needs
Promoting resiliency among SIBLINGS of children with autism spectrum disorder (ASD)
Principal Investigators: Karen Kuhlthau, PhD & Elyse R. Park, PhD, MPH
Funding Source: US Health Resources and Services Adminsistration (HRSA)
Project Number: N/A
Description: Building on our work with parents of children with ASD, we adapted a program for siblings of children with ASD. To learn more about the experience of being a sibling of a child with ASD. We completed a pilot wait-list controlled trial.
Potential participants: We are recruiting siblings, nationally, of children any age with Autism Spectrum Disorder.
Contact information: For more information, please email Lucy Fell (lfell@mgh.harvard.edu).
Promoting resiliency among FATHERS of children with autism spectrum disorder (ASD)
Principal Investigators: Karen Kuhlthau, PhD & Elyse R. Park, PhD, MPH
Funding Source: US Health Resources and Services Adminsistration (HRSA)
Project Number: N/A – Project under development
Description: Expanding our reach to fathers of children with special needs, we are conducting in-depth interviews and will pilot an adapted version of our resiliency treatment for fathers.
Potential participants: We are recruiting fathers, nationally, of children any age with special needs.
Contact information: For more information, please email Lucy Fell (lfell@mgh.harvard.edu).
Mind-body Resiliency Data Repository
Principal Investigator: Elyse R. Park, Ph.D., MPH
Funding Source: N/A
Project Number: N/A
Description: The purpose of the Resiliency Data Repository is to provide a centralized data warehouse that will make the research and clinical data collected from participants in clinical resiliency programs. Typically, participants in these programs are individuals dealing with an ongoing stressor and/or chronic illness. Participants include adult and young adult cancer survivors, relatives of children with learning and attentional disabilities, and women with HIV. Data collected may relate to, or reflect, participant quality of life, such as data regarding engagement in health behaviors (e.g., healthy eating, physical activity, sleep quality), resiliency, social support, emotional distress, positive affect, and mindfulness. The data repository will standardize and streamline the collection, management and analysis of this data from these clinical and research projects.
Potential participants: We are recruiting clinical and research participants enrolled in resiliency treatment programs and research.
Contact information: For more information, please email Lucy Fell (awrasmussen@mgh.harvard.edu)
Workforce Mental Health
Promoting Resiliency and Mental Health Among Health Professional Workforce
Principal Investigator: Watura Finley, The Mass League of Community Healthy Centers & MGH Principal Investigator: Gaurdia Banister, PhD
Co-Investigators: Elyse R. Park, Ph.D., MPH and Louisa Sylvia, Ph.D.
Funding Source: U.S. Health Resources and Services Administration (HRSA)
Description: The prolonged strain of the COVID-19 pandemic has taken an emotional toll on healthcare workers who continuously face resource-constraints, perpetual uncertainty about the overall impact and duration of the pandemic, changes in clinical knowledge and guidelines, and the high rates of patient mortality and morbidity. The goals of this project are to (1) identify and implement evidence-based informed programs that promote resilience, wellness, and mental health among the health center workforce serving in rural and medically underserved areas of Massachusetts and (2) to enhance organizational cultures at these health centers to move towards a sustainable model for enhancing employee mental health and wellness.
Potential participants: Currently enrolling participants.
Be Well at Work-Plus: Engaging low-wage workers in the design and implementation of a depression and physical activity intervention.
Principal Investigator: Jessica McCurley, PhD, MPH
Funding Source: National Heart, Lung, and Blood Institute (NHLBI)
Project Number: K23HL157763
Description: Low-wage workers comprise one third of all workers in the U.S. and have a high prevalence of cardiometabolic risk factors, including depression and physical inactivity. This study will develop and test a dynamic workplace-based telehealth depression intervention that is tailored to the specific social and behavioral needs of low-wage workers. In addition to Cognitive Behavioral Therapy to support work productivity, the intervention will include assessment and referrals for social determinants of health, physical activity promotion, and personalized text message support for mood and physical activity. This study will be developed using a planned adaptation approach and will involve low-wage workers in the design of the intervention.
Potential participants: This study will be recruiting adult low-wage hospital service and support workers with depression.
TENDAI Study: Task shifting to treat depression & HIV medication nonadherence
Principal Investigator: Conall O’Cleirigh, PHD; Melanie Abas, MD
Funding Source: National Institute of Health (NIH)
Project Number: R01 MH1147018
Description: Zimbabwe has the 5th highest prevalence of HIV globally, and depression has been identified as a major hurdle to people living with HIV (PLWH) adhering to their antiretroviral medication in this setting. Unfortunately, due to the dearth of mental health professionals in sub-Saharan Africa, there is a significant depression treatment gap. This project is a two-arm randomized effectiveness trial (n=290) evaluating the effectiveness and cost-effectiveness of a brief, stepped-care intervention for depression and ART adherence (TENDAI), in compared with an enhanced standard care condition, in patients living with HIV in rural Zimbabwe. To counter the mental health treatment gap, this study prioritizes task-shifting using adherence counselors and nurses as interventionists, and the stepped-care approach utilizes three successive intensity levels of depression treatment for non-responders to maximize efficient use of resources in resource limited settings. Outcomes for the project include viral suppression, medication adherence, and depression.
Potential Participants: This study will be recruiting HIV-positive adults with clinically significant depression symptoms and an uncontrolled viral load in Mashonaland East Province, Zimbabwe.
Hybrid effectiveness-implementation trial for ART adherence & substance use in HIV care in S. Africa
Funding Source: National Institute on Drug Abuse (NIDA)
Project Number: K23 DA041901
Description: The HIV epidemic in South Africa is among the highest in the world. South Africa has a large antiretroviral therapy (ART) program, but some individuals exhibit poor ART adherence, which increases the likelihood of developing drug resistance and failing the only available first and second line ART regimens in this setting. Unfortunately, ART nonadherence contributes to greater morbidity, mortality, and higher likelihood of sexual HIV transmission when the virus is detectable. At the same time, alcohol and other drug use is prevalent among HIV-infected individuals in South Africa and is associated with worse ART adherence, lower rates of viral suppression, and HIV risk behavior. Yet, despite the impact of untreated substance use on poor HIV treatment outcomes and continued HIV transmission, there is little if any integration of substance use and HIV care services in South Africa, which creates a fragmented and incomplete system of care. The current study had three phases, the first phase being formative, qualitative work which led to a systematic adaptation phase (Phase II). This study is currently in its third phase, the clinical trial, based on the formative work from the first phase and other empirical support using behavioral interventions to improve ART adherence and reduce substance use in resource-limited settings, including South Africa. The study is a Type 1 hybrid effectiveness-implementation trial of a lay counselor-delivered behavioral intervention for adherence and substance use integrated into the HIV primary care setting in South Africa. To ensure that those who need this intervention most will receive it, participants will be patients living with HIV who are struggling with adherence and who have an elevated substance use risk.
Potential participants: No longer recruiting.
Mental health barriers to PrEP uptake among pregnant women in South Africa
Principal Investigator: Amelia M. Stanton, PhD
Funding Source: Harvard Center for AIDS Research NIH/NIAID 5P30AI060354-17
Description: South Africa (SA) has the largest population of individuals living with HIV in the world. Women of reproductive age in SA are at disproportionately high risk for acquiring HIV compared to their male counterparts. Potential reasons for this discrepancy include gender-based violence, lack of agency in the context of intimate partnerships, sex with older men who are more likely to be infected, and low condom use rates. Pregnant women face particularly high HIV risk, as pregnancy and breastfeeding are associated with increased biological susceptibility to HIV infection. Adherence to once daily oral tenofovir-based PrEP is efficacious in preventing HIV acquisition, but PrEP uptake, adherence, and persistence in SA and has been poor. Pregnant women in SA are interested in taking PrEP, but they face numerous challenges, including psychological issues associated with intimate partner violence, traumatic stress, and depression, which may compromise engagement in HIV prevention behaviors. The main objective of this study is to collect mixed-methods data to inform a future cognitive behavioral therapy intervention that facilitates PrEP persistence by addressing relevant psychological barriers among HIV-negative pregnant and postpartum women.
Potential participants: Currently enrolling participants in South Africa.
Falling off the HIV treatment cascade cliff: Understanding postpartum attrition to HIV care
Principal Investigator: Christina Psaros, PhD
Funding Source: National Institute of Mental Health (NIMH)
Project Number: R01 MH112385
Description: The province of KwaZulu-Natal, South Africa, has the highest prevalence of HIV among pregnant women in the world: 40% of women enrolled in antenatal care are living with HIV. Pregnancy is an important time to engage women in HIV care to eliminate perinatal transmission through prevention of mother to child transmission programming (PMTCT), but it also presents an opportunity to engage women in lifelong HIV care. Many women leave HIV care during the postpartum period, even though ongoing care is imperative to maintaining their health and the health of their infants. The research community does not know enough about why women leave HIV care during the postpartum period, thus we cannot yet design interventions to retain more women in HIV care. The goal of this study is to better understand barriers to and facilitators of remaining in HIV care after having a baby in the province of KwaZulu-Natal, South Africa, with the ultimate goal of developing interventions to best support the health of women living with HIV and their children.
Potential participants: No longer recruiting.
PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women
Principal Investigator: L. Matthews
Co-Investigator: Christina Psaros, PhD
Funding Source: NIMH / R01 MH10842
Description: This is a single-arm study to offer daily oral PrEP for periconception use, in conjunction with safer conception counseling, to 350 HIV-uninfected women in KwaZulu-Natal, South Africa who report personal or partner plans for pregnancy and a partner who is HIV-infected or HIV-status unknown.
Potential participants: No longer recruiting.
A qualitative ancillary study of HPTN 083
A phase 2b/3 double blind efficacy study of quarterly injectable cabotegravir compared to daily oral tenofovir/emtricitabine (Truvada), for PrEP in HIV uninfected MSM and transgender women
Protocol Chairs: Christina Psaros, PhD & Steve Safren, PhD
Funding Source: National Institute of Health (NIH)/ National Institute of Allergy and Infectious Diseases (NIAID) / National Institute of Mental Health (NIMH)
Project Number: HPTN 08320725
Description: The objective of this study is to (1) identify potential barriers, facilitators, and potentially modifiable issues related to adherence to clinic visits in the context of injectable PrEP; (2) learn about preferences and decision-making regarding the use of oral versus injectable PrEP, or other biomedical prevention products; and (3) gather explanatory qualitative data regarding participants’ experiences in HPTN 083 to better interpret study results and guide next step prevention strategies.
Potential participants: No longer recruiting.
Nurse-delivered CBT for depression-adherence in HIV primary care in South Africa
Principal Investigator: Conall O’Cleirigh, PhD; Steven Safren, PhD, ABPP
Funding Source: National Institute of Health (NIH)
Project Number: R01 MH103770
Description: This study involved a two-arm randomized effectiveness trial investigating whether a task shifting/sharing model of treating depression and improving adherence to ART in patients who fail first line antiretroviral therapy (ART) can occur using nurses in South Africa trained in CBT. South Africa is the country with the highest number of HIV infections in the world and the highest number of HIV/AIDS-related deaths, and where access to third line ART treatment is not currently available in the public healthcare system. Clinical depression, like elsewhere, is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success. The U.S. based investigators have developed and successfully tested an approach integrating adherence counseling into cognitive- behavioral therapy for depression in HIV. The South Africa based team, in collaboration with the U.S. based team, has conducted preliminary work to evaluate the cultural appropriateness and feasibility of integrating this approach into the South African HIV treatment setting.
Accordingly, we have:
Development of a trauma-informed intervention to support adaptive engagement in care among MSM
Principal Investigator: Conall O’Cleirigh, PhD, Trevor Hart, Ph.D.
Funding Source: The Fenway Institute/The Ontario HIV Treatment Network
Description: Gay and bisexual men and other men who have sex with men (MSM) experience significant mental health disparities particularly, distress, trauma, depression and substance use compared to heterosexual men. Rates of PTSD and substance use are twice among gay and bisexual men and other MSM compared to heterosexual men. The relative high frequency of mental health problems among MSM may be even higher among MSM living with HIV/AIDS. For example, in a sample of over 500 gay and bisexual men living with HIV in primary care, 47% met diagnostic criteria for an anxiety disorder (inclusive of PTSD). These problems are not only distressing and interfering in and of themselves, but also are associated with health concerns such as higher risk of HIV or STI acquisition and, for MSM living with HIV/AIDS, suboptimal engagement in HIV and STI treatment uptake and care. Accordingly, no matter what new biomedical or behavioral HIV prevention or treatment tools emerge as we approach 2020, those at highest risk for HIV acquisition or worse HIV treatment outcome are likely to be those affected by comorbid mental health problems.
The purpose of this study was to:
This project was conducted at Fenway Health in Boston, MA and Ryerson University in Toronto, Canada.
Promoting resiliency among parents of children with autism spectrum disorder (ASD)
Principal Investigator: Karen Kuhlthau, PhD (Elyse R. Park, PhD, MPH, Co-Investigator)
Funding Source: HRSA
Project Number: N/A
Description: In addition to running the SMART-3RP with parents of LD, we are developing an adapted program for parents of children with ASD. To learn more about the experience of raising a child with ASD, we are running focus group interviews with parents of ASD. These interviews will inform an 8-week virtual-delivery program for parents of ASD.
Potential participants: We are recruiting parents, nationally, of children any age with Autism Spectrum Disorder to take part in a 1 hour-long interview to help us learn more about parenting a child with ASD.
Contact information: For more information, please email ParentalStressStudy@partners.org, or contact Emma Chad-Friedman at 617-643-6036.
Evaluating recovery coaches to improve treatment outcomes & reduce health care costs among patients
Principal Investigator: Jessica Magidson, PhD and Sarah Wakeman, MD
Funding Source: Partners Population Health Management
Project Number: N/A
Description: This grant aims to evaluate the clinical and cost effectiveness of integrating peer recovery coaches into primary care for outpatient management of substance use disorders, examining whether recovery coach involvement can improve substance use treatment outcomes and reduce health care costs among patients with substance use disorders.
Promoting resiliency among parents of children with learning and attention disabilities (LD)
Principal Investigator: Elyse R. Park, PhD, MPH
Funding Source: The Marino Foundation
Project Number: N/A
Description: According to the 2011/12 National Survey of Children’s Health, 14.6 million children in the U.S. have special health care needs (e.g., learning disability, ADD/ADHD, developmental delays, chronic mental or physical health conditions), and learning disabilities (LD) are the largest category of students receiving special education services. Having a child with LD is associated with an increased risk of problems with emotional and physical health and social well-being. Resiliency is a multidimensional construct that refers to the ability to maintain adaptation and effective functioning when faced with stressors. Resiliency provides a framework for understanding the adjustment to stress as a dynamic process. We will personalize and target the Stress Management and Resiliency Training- Relaxation Response Resiliency Program (SMART 3RP) to parents of children with LD. We will determine the feasibility, and acceptability, and efficacy of an 8-week group 3RP intervention to parents of children with special health care needs. Lastly, we will pilot test the end-of-treatment effects of the SMART 3RP on parents’ stress levels using health-relevant biomarker measures.
Developing a resilience intervention for older, HIV-Infected women
Principal Investigator: Christina Psaros
Funding Source: NCCIH / R34 MH118044
Description: The number of older, HIV-infected women in the U.S. is growing. In fact, it is estimated that approximately 50% of the HIV-infected population will be over age 50 by 2020, and a significant percent of women, particularly women of color, continue to be impacted by HIV/AIDS. Additionally, the experience of aging with HIV results in complex biopsychosocial challenges for women, which are experienced as stressors. Despite this, few interventions have been developed for older adults with HIV, and none have focused on women. The goal of this project is to adapt a 10-week mind-body resiliency intervention to the needs of women living with HIV over 50 and to test the feasibility and acceptability of the adapted group intervention in a small randomized controlled trial.
Developing a pilot lifestyle intervention to prevent cardiovascular disease among HIV-infected women
Principal Investigator: Greer A. Raggio, PhD, MPH
Funding Source: Harvard University CFAR/NIH/NIAID
Description: Cardiovascular disease contributes to 10-15% of deaths among people living with HIV in North America, and HIV-infected women have a 50% greater relative risk for incident cardiovascular disease than HIV-infected men. Older HIV-infected women in particular face unique challenges that may impede adherence to healthy lifestyle behaviors and increase the risk of cardiovascular disease. However, no existing lifestyle interventions target older HIV-infected women.
In this study, we will:
Identifying critical elements of discussions between providers, patients & families at end of life
Principal Investigator: Lara Traeger, PhD
Funding Source: American Cancer Society
Description: The goal of this study is to examine the nature and characteristics of discussions between palliative care providers and patients/families with metastatic cancer during key transitions in end-of-life care.
Intersecting stigmatized identities and engagement in HIV treatment (INSIGHT) study
Principal Investigator: Abigail Batchelder, PhD, MPH
Funding Source: Harvard Center for AIDS Research NIH/NIAID 5P30AI060354-13
Description: Men who have sex with men (MSM) continue to be disproportionately affected by HIV in the US and in Massachusetts; they also have higher rates of distress and substance use compared to heterosexual men. Further, the sexual minority stress theory posits that stigma accounts for higher rates of psychological distress and substance use. Emerging evidence indicates that when stigma is internalized, it can be experienced as chronic trauma. Internalized stigma is associated with poor engagement in care, including nonadherence to antiretroviral treatment (ART), which may be intensified by, the co-occurrence of intersecting internalized stigmas. Leveraging recent findings on the intersectionality of identities and related-chronic trauma, this mixed methods study will provide critical qualitative and quantitative data to adapt a promising intervention (Project MATTER) to address substance use and HIV-related shame and associated thoughts (e.g., internalized HIV and substance use-stigma), as barriers to engagement in HIV care. The intervention incorporates components of evidence-based cognitive behavioral therapy (CBT) with an innovative bidirectional text message platform to enhance emotional self-regulation to improve engagement in HIV care among HIV+ substance users.
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Conall O’Cleirigh, PhD
Christina Psaros, PhD
Abigail Batchelder, PhD, MPH
Jamie Jacobs, PhD
Elyse Park, PhD, MPH
Daniel Hall, PhD
Lara Traeger, PhD
Giselle Perez, PhD
Rachel Millstein, PhD
Emily Feig, PhD
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