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The Behavioral Medicine Program at Massachusetts General Hospital is at the forefront of research focused on developing, validating and disseminating psychosocial interventions to help individuals with a variety of health and medical issues. The research conducted by the scientists of the Behavioral Medicine Program is focused on developing and validating new psychosocial interventions to help individuals with a variety of health and medical issues. We conduct research both domestically and internationally across three continents.
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:
Principal Investigator: Bettina Hoeppner, PhD
Co-Investigator: Conall O’Cleirigh, PhD
Funding Source: NIH
Project Number: 1R21CA261458-01
Description: HIV positive smokers 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 smokers.
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: National Institute on Drug Abuse
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 smokers are now, more than ever, at heightened risk for tobacco-related illness and death. In fact, PLWH smokers engaged in treatment lose more years of life due to smoking now than to HIV disease. Although PLWH smokers 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.
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: National Institute on Drug Abuse
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. Smokers living with HIV 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 smokers living with HIV include exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression.
The purpose of this study is to:
Principal Investigator: Elyse R. Park, PhD, MPH; Nancy A. Rigotti, MD; Jennifer S. Haas, MD, MSPH
Funding Source: National Cancer Institute
Project Number: R01CA218123
Description: This project will address the integration of a virtual tobacco cessation treatment into lung cancer screening in a large integrated health care delivery system by integrating into its LDCT-LCS sites a novel, personalized, evidence-based smoking cessation intervention in English and Spanish.
Currently enrolling participants.
Principal Investigator: Elyse R. Park, PhD, MPH; Jamie Ostroff, PhD
Funding Source: National Cancer Institute
Project Number: 1R01CA214427-01A1
Description: The aim of this study is to conduct an effectiveness-implementation trial to assess virtual delivery of an evidence-based tobacco treatment intervention in cancer community sites affiliated with the newly established NCI community Oncology Research Program nationally.
Currently enrolling participants.
Principal Investigator: Elyse R. Park, PhD, MPH
Funding Source: National Cancer Institute
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.
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.
Principal Investigator: Jessica McCurley, PhD, MPH
Funding Source: National Heart, Lung, and Blood Institute
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.
Principal Investigator: Allison Applebaum, PhD and Douglas Mennin, PhD (MGH Site PI: Jamie Jacobs, PhD)
Funding Source: National Cancer Institute
Project Number: R01CA244185
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. Interested patients or caregivers may contact Kate Morgan for more information at caregivingresearch@mgh.harvard.edu.
Principal Investigator: Areej El-Jawahri, MD
Co-investigator: Lara Traeger, PhD
Funding Source: American Cancer Society
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.
Principal Investigator: Deborah Forst, MD
Co-investigator: Jamie Jacobs, PhD
Funding Source: Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO)
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. For more information about this study contact Michelle Mesa: mmesa@mgh.harvard.edu.
Principal Investigator: Daniel L. Hall, PhD
Funding Source: National Center for Complementary and Integrative Health
Project Number: K23At010157
Description: This is a 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.
Potential Participants: We anticipate opening recruitment for our pilot trial early 2021. To learn more about this research study, please contact the study coordinator at hmizrach@mgh.harvard.edu or 617-982-3972.
Principal Investigator: Daniel L. Hall, PhD
Funding Source: American Cancer Society
Project Number: Institutional Research Grant
Description: This is a study to test the feasibility, acceptability, and preliminary effects of a 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. 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 and will explore preliminary effects on evening actigraphy measures.
Potential Participants: We are looking for cancer survivors experiencing difficulty sleeping to participate in study testing a 4-week virtual cognitive behavioral program. If you are interested in participating in this research, please contact the study coordinator at hmizrach@mgh.harvard.edu or 617-982-3972.
Principal Investigator: Jamie Jacobs, PhD
Funding Source: MGH ESSCO Breast Oncology
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 culturally sensitive intervention to address cultural barriers to starting endocrine therapy. For more information contact Shibani Datta: sdatta12@mgh.harvard.edu.
Principal Investigator: Jamie Jacobs, PhD
Funding Source: National Cancer Institute
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: We are currently recruiting female breast cancer survivors who have completed active treatment (e.g., surgery, chemotherapy, radiation) for early-stage, ER+/PR+ breast cancer and are currently taking endocrine therapy (e.g., Tamoxifen, Arimidex, Aromasin, Femara, Faslodex, Zoladex). Participants will complete a 20-30 minute phone interview with research staff.
For more information, please contact: Emily Walsh, 617-724-1414
Principle investigator: Jamie Jacobs, PhD
Funding Source: National Cancer Institute
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.
Potential participants: We are currently recruiting female breast cancer survivors who have completed active treatment (e.g., surgery, chemotherapy, radiation) for early-stage, ER+/PR+ breast cancer and are currently taking endocrine therapy (e.g., Tamoxifen, Arimidex, Aromasin, Femara, Faslodex, Zoladex).
For more information, please contact: Jamie Jacobs, 617-724-1414
Principal Investigators: Elyse Park, PhD; Giselle Perez Lougee, PhD
Funding Source: American Cancer Society
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.
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.
Currently enrolling participants.
Principal Investigator: Perez Lougee, PhD
Funding Source: National Cancer Institute
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.
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.
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.
Innovation Award
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.
To learn more about this study, please contact the study coordinator at: kmassad@mgh.harvard.edu
Principal Investigator: Lara Traeger, PhD
Funding Source: American Cancer Society
Project Number: ACS MRSG PCSM 1410701
Description: This study is a trial of the Transitions Program, a telehealth intervention for up to 45 adults who have been treated for lung cancer or mesothelioma with curative intent. As patients finish cancer treatment and move on (“transition”) to surveillance or follow-up care, they may face a range of unexpected concerns. Some of these concerns may include lingering symptoms, changes in social support, and uncertainty about the future, which can impact important areas of wellbeing. Study participants who are assigned to the Transitions Program will receive up to five sessions with a study clinician to learn and practice strategies for enhancing their quality of life. We aim to test the feasibility and acceptability of the Transitions Program, along with its benefits to quality of life. This study is a critical step toward enhancing quality of life during a critical but often neglected phase of cancer care for patients with thoracic cancers.
Potential Participants: If you are interested in participating in this research, please contact the study coordinator at kmassad@mgh.harvard.edu.
Principal Investigator: Conall O’Cleirigh, PhD, Associate Director
Description: In his role as Associate Director of the Harvard University CFAR Behavioral and Social Sciences (BSS) Core, Dr. O’Cleirigh provides consultation on developing and supporting HIV-related clinical research. The Core provides services to behavioral and biomedical researchers; will leverage ongoing biomedical projects to integrate behavioral/social science and conduct add-on behavioral/social science studies; and will engages community stakeholders to increase buy-in of research and acceptance of new biomedical technologies.
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.
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. The well-supported Stress and Coping Theory suggests that the relationship between internalized stigma and poor engagement in HIV care may be due to avoidant coping, a common outcome of 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. However, the mechanisms by which intersecting internalized stigmas (e.g., being MSM, HIV+, or a substance user) lead to worse HIV outcomes are neither well understood nor addressed with existing interventions. Leveraging recent findings on the intersectionality of identities and related-chronic trauma, this study will expand on my previous work by providing critical data to adapt a promising intervention that I originally designed 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 in order to improve engagement in HIV care among HIV+ substance users.
Goals:
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 more strategically intervene on these barriers to HIV care. This K23 aims to elucidate underlying behavioral and social mechanisms associated with substance use and to optimize treatment success among MSM sub-optimally engaged in HIV care. This work involves three aims. 1) The assessment of the interrelationships between HIV care cascade indicators (i.e., linkage and engagement in care), substance use, and stigma-related emotions, informed by three measurements (recently validated nonverbal behavioral coding, narrative coding, and self-report).
This study will also assess whether avoidant coping mediates these relationships. 2) Focus groups with this target population in order to obtain feedback to be integrated with the results from the secondary data analysis to inform the refinement of a previously developed emotion regulation intervention (PI Batchelder: supported by UCSF’s Center for AIDS Prevention Studies Innovative Early Investigator Award) designed to improve engagement in HIV-care among substance using HIV+ MSM sub-optimally engaged in care. 3) A pilot randomized controlled trial (RCT) of the refined intervention with substance using HIV+ MSM 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.
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: The Fenway Institute
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 is to:
This project is being conducted at Fenway Health in Boston, MA and Ryerson University in Toronto, Canada.
Potential Participants: If you are interested in participating, please call 617-927-6465 (Boston site) or 416-979-5000 (Toronto site)
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: Centers for Disease Control and Prevention
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.
(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: 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.
Co-Principal Investigators: Christina Psaros and M. Kempf
Funding Source: NCCIH / 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.
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: NIH/NIAID
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.
Principal Investigators: S. Safren and K. Mayer
Co-Investigator: Christina Psaros
Funding Source: 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.
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.
Principal Investigator: Lara Traeger, PhD
Funding Source: Erickson Living
Description: Mind-body medicine offers key strategies to help older adults enhance their health, resilience and capacity to flourish. This pilot study is designed to test the feasibility of integrating a mind-body group program into senior living communities. We also will explore participant satisfaction and potential benefits of program participation. This study will be conducted in collaboration with Erickson Living senior living communities across the U.S. We will use study results to guide next steps for larger scale program implementation.
To learn more about this study, please contact the study coordinator at gstyklunas@mgh.harvard.edu
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.
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 qualitative study is to better understand the lived experiences of physical activity in patients who have undergone bariatric surgery, in particular the emotions they experience when engaging in physical activity. The results will inform the development of a positive psychology-based intervention to increase physical activity after bariatric surgery.
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 looking to recruit people 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).
Principal Investigators: Jillian Scheer
Co-Investigator: Abigail Batchelder, PhD, MPH
Funding Source: Yale Fund for Lesbian and Gay Studies
Description: This study aims to understand the trajectory of minority stress among sexual minority women with posttraumatic stress symptoms using daily diaries.
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.
Principal Investigators: Karen Kuhlthau, PhD & Elyse R. Park, PhD, MPH
Funding Source: 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 recruited siblings, nationally, of children any age with Autism Spectrum Disorder.
Contact information: For more information, please email Lucy Fell (lfell@mgh.harvard.edu).
Principal Investigators: Karen Kuhlthau, PhD & Elyse R. Park, PhD, MPH
Funding Source: 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).
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: Clinical and research participants enrolled in resiliency treatment programs and research.
Contact information: For more information, please email Lucy Fell (awrasmussen@mgh.harvard.edu)
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: The Fenway Institute
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 is to:
Potential Participants: If you are interested in participating, please call 617-927-6465 (Boston site) or 416-979-5000 (Toronto site)
Principal Investigator: Conall O’Cleirigh, PhD; Steven A. Safren, PhD; Matthew Mimiaga, ScD
Funding Source: National Institute of Mental Health (NIMH)
Project Number: R01 MH100627
Description: The goal of this multi-site randomized controlled trial is to examine the efficacy of an intervention to reduce HIV and STI risk among MSM in India. This 2-arm RCT compares a self-acceptance based HIV risk reduction intervention with voluntary HIV/STI counseling and testing (VCT) to VCT among MSM in Chennai and Mumbai, India.
Potential participants: Recruitment took place at two sites in India from 2015 to July 2018.
Principal investigator: Jessica Magidson, PhD
Funding Source: 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: Recruitment taking place in Cape Town, South Africa.
Principal Investigator: Conall O’Cleirigh, PhD; Steven Safren, PhD, ABPP
Funding Source: NIH
Project Number: R01 MH103770
Description: This is a proposal to conduct 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:
Potential Participants: This study will be recruiting HIV-positive adults with a current diagnosis of depression and an uncontrolled viral load in South Africa.
Principal Investigator: Conall O’Cleirigh, PHD; Melanie Abas, MD
Funding Source: 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.
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: NIH/NIAID
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.
Principal Investigator: Christina Psaros, PhD
Funding Source: NIH
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.
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.
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: National Institute of Drug Abuse (NIDA)
Project Number: R34 DA031038
Description: This trial provided important information regarding the potential efficacy and mechanisms of an integrated intervention for and at risk group of HIV+ smokers, namely those who also have clinically significant anxiety problems (>60% of HIV+ smokers). Identifying efficacious treatments for smoking cessation for HIV+ adults has considerable public health significance because cigarette smoking is the leading cause of death and disability in the United States (U.S.), contributing to over 440,000 deaths each year, and HIV+ smokers comprise an overrepresented group among smokers. This study yielded important information in the treatment of drug use and anxiety symptoms in HIV+ individuals, including how best to treat this vulnerable population. Moreover, this study guided advances in the theoretical conceptualization of the mechanisms involved in HIV-anxiety- smoking relations.
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: NIH
Project Number: R21 DA038197
Description: Men who have sex with men (MSM) in the US are most heavily affected by HIV, representing ~63% of all new HIV infections annually. With highly effective HIV medication and consistent engagement in HIV health care, these MSM are living longer; by 2015 it is estimated that more than 50% of Americans living with HIV will be 50 years of age or older. Evidence is emerging that chronic pain is prevalent in older HIV-infected patients and likely occurs synergistically with substance use and abuse, which predispose to non-engagement and non-retention in HIV care, non-adherence to HIV medications and sexual risk taking. Understanding these relationships and incorporating pain management strategies in health interventions will forge the development of a tailored behavioral-based, integrated intervention that has the potential to improve pain management, reduce substance use (and/or its interference in HIV disease management) and improve ART adherence and engagement in care Design. The purpose of this research application is to develop and openly pilot an integrative intervention for older HIV- infected MSM)who report chronic pain and substance-using behaviors that interfere with engagement in care and sexual risk taking. The application has the potential to change the manner in which older HIV infected MSM with chronic pain and substance abuse are treated, thus increasing quality of life and longevity in this population.
Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: NIH
Project Number: R01 MH095624
The prevalence of HIV among men who have sex with men (MSM) is estimated at an alarming 19% domestically, rates comparable to endemic settings in certain regions of sub-Saharan Africa where approximately 20% of the adult population is HIV infected. Studies have also demonstrated a staggeringly high prevalence of childhood sexual abuse (CSA) in MSM, and shown an association between CSA and HIV risk in MSM. A successful intervention for MSM with a CSA history to prevent HIV has the potential to avert infections among some of the riskiest members of the most HIV vulnerable group in the U.S. Notwithstanding the ability of the existing HIV prevention interventions to show reductions in sexual risk taking, the recent successes of chemoprophylaxis, current policy initiatives, and empirically supported recommendations, all support development of combination prevention interventions that can specify multiple prevention targets, address related risk factors and barriers, and are grounded in a community context. The pathways from CSA to adult sexual risk behavior are varied and complex and this complexity is appropriately addressed in individual-based interventions where empirically supported interventions for CSA related trauma were efficacy tested. The development of an integrated prevention intervention that utilizes cognitive behavioral technologies to address co-occurring and interfering CSA and sexual risk represents a novel and largely untested innovative application that is theoretically designed to address sexual risk directly and indirectly through reductions in CSA-related trauma symptoms. The flexibility of integrated and combination prevention programs has the potential to support triage of MSM with risk profiles to the programs that best meet their prevention needs.
This two-arm RCT is designed to test the efficacy of a psycho-social intervention that addresses intersecting epidemics among MSM, HIV and CSA. The experimental condition integrates sexual risk reduction counseling with Cognitive Processing Therapy for Trauma and Self Care (CPT-TSC). CPT-TSC has been specifically piloted on MSM with CSA histories and sexual risk to reduce interfering negative CSA-related thoughts about self, to more accurately appraise sexual risk, and to decrease avoidance of sexual safety considerations through rehearsals of sexual safety behaviors. The active and time-matched comparison condition is risk reduction counseling plus supportive psychotherapy. The primary outcome will be self-reported sexual risk taking as assessed via a computer-based questionnaire. Secondary outcomes include trauma symptom severity, both cognitive and behavioral.
Project THRIVE was conducted at Fenway Health in Boston, MA and the University of Miami in Miami, FL.
Principal Investigator: Sannisha K. Dale, PhD, EdM
Funding Source: National Institute of Mental Health (NIMH)
Project Number: 1K23MH108439-02
Description: Among women in the U.S, Black women are the most impacted by HIV. Relevant psychosocial and contextual factors facing Black women with HIV include having a history of abuse, posttraumatic stress, racial discrimination, HIV-related stigma/discrimination, and prescribed female traditional gender roles; each of which are associated with worse HIV outcomes. Despite the need, there is currently no evidenced-based psychosocial intervention for Black women with HIV that addresses these contextual factors. The purpose of the current study is to develop and assess the feasibility and acceptability of an intervention for Black women with HIV that combines evidence-based strategies for trauma symptom reduction, strategies for coping with racial and HIV-related discrimination, gender empowerment, problem solving techniques for medication adherence, and other resilient coping techniques.
Specific aims:
Principal Investigator: Douglas Krakower, MD
Funding Source: Center for AIDS Research
Project Number: NCT03493555
Description: New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). Oral pre-exposure prophylaxis (PrEP) can reduce HIV acquisition among MSM over 90% when adherence levels are high, and increasing the effective use of PrEP among YMSM is one of the highest priorities in HIV prevention. However, YMSM face multiple barriers to initiating and adhering to PrEP, including structural barriers (e.g. housing insecurity), psychosocial factors (e.g. substance use, depression), underestimation of their risk for acquiring HIV, and ambivalence about using PrEP due to medical mistrust. In an open-label study of PrEP use by 200 YMSM, only one-third of participants had protective levels of drug in their blood at 1 year despite intensive adherence counseling, and HIV incidence was high at 3% per year. When PrEP is prescribed to YMSM in care settings, where adherence support is less intensive than in clinical studies, adherence levels, and thus effectiveness, are likely to be even lower. Without strategies to optimize adherence to PrEP for these youth, PrEP is unlikely to have a major impact on HIV incidence for YMSM.
One approach to overcoming the multi-factorial barriers that prevent YMSM from adhering to PrEP is the use of peer health system navigators. Navigators are healthcare workers who are trained to support adherence and retention in care for individuals who are at risk for suboptimal adherence. For YMSM who use PrEP, peer navigators could support adherence by connecting youth with resources to address their unmet structural and psychosocial needs and by helping them to negotiate the complexities of healthcare systems. As navigators have been used for over a decade to improve adherence in HIV-infected persons, and an evaluation showed that HIV-infected persons who used navigators had higher rates of virologic suppression, it is important to test whether peer navigation can optimize adherence to PrEP for YMSM.
Our long-term goal is to optimize adherence to PrEP for YMSM and thus decrease HIV incidence. The objective of this study, the first step towards our goal, is to develop and pilot test a peer navigator program to optimize adherence to PrEP for YMSM.
This project is being conducted at the Sidney Borum Jr. Health Center in Boston, MA.
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.
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.
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.
Potential participants: We are recruiting parents, nationally, of children any age with learning or attention disabilities. For more information, please email ParentalStressStudy@partners.org, or contact Emma Chad-Friedman at 617-643-6036.
This program is for parents and is once a week, for 1 hour/ week for 8 consecutive weeks. Participation will be done virtually (via videoconferencing). To participate in this study, we ask you to complete three questionnaires over the course of 6 months, as well as to provide two hair samples to measure cortisol levels.
If interested in participating, please complete the pre-screen questionnaire. We will contact you soon to let you know about beginning the program.
Principal Investigator: Elyse R. Park, PhD, MPH
Funding source: National Cancer Institute
Project number: R01 CA166147
Description: A multi-site randomized controlled comparative effectiveness trial will enroll 295 current smokers with suspected or newly diagnosed melanoma, lymphoma, thoracic, breast, genitourinary, gastrointestinal, head and neck, or gynecologic cancer. Participants will be randomly assigned to receive the Intensive Treatment (IT) or Standard Treatment (ST) condition. Both groups will receive an initial motivational counseling session and 3 weekly follow-up counseling sessions with a tobacco treatment counselor, conducted in-person or by telephone. The IT arm has the option to also receive an additional 4 biweekly and 3 monthly proactive counseling sessions and up to a 12-week supply of FDA-approved smoking cessation medication at no cost.
Potential participants: Mass General patients who have smoked a cigarette, even a puff, within the last 30 days with newly diagnosed or suspected cancer, who are English or Spanish-speaking may be eligible. If you are interested in participating, please contact the study coordinator at 617-643-4765 or email smokefreesupportstudy@partners.org.
Principal Investigator: Christina Psaros, PhD
Funding Source: National Institute of Mental Health (NIMH)
Description: Rates of HIV infection among young women in South Africa are among the highest in the world. Adolescent women in South Africa represent part of the "second generation" of HIV affected youth, a cohort that remains understudied. Adolescent women coming of age today likely have different experiences related to HIV than the generation before; we explored how the experiences of these women may impact current HIV risk behavior to learn how to best intervene in order to reduce rates of HIV in the future.
Principal Investigator: Christina Psaros, PhD
Funding Source: National Institute of Mental Health (NIMH)
Project Number: 1K23MH096651
Description: The United Nations Millennium Development Goals (MDGs) illustrate key areas in which the lives of women and children worldwide are in need, including improving maternal health and a reduction in childhood mortality. The success of meeting both these goals depends on reducing rates of vertical transmission of HIV. Sub-Saharan Africa is one of the areas targeted by the MDGs and bears a substantial degree of HIV disease burden, with well over 22 million people living with HIV at the end of 2008, a significant number of whom are women of reproductive age. Depression has been associated with non-adherence to the series of health behaviors known as preventing mother-to-child transmission (PMTCT) of HIV. Women in resource limited settings are likely to face additional barriers to PMTCT adherence, including stigma and structural barriers. While structural barriers may be circumvented by relying on community resources (known as social capital), depression and stigma may make it difficult to access these resources. Thus, understanding the role of modifiable factors that contribute to PMTCT adherence is critical to meeting the goals of the MDGs. The goals of the proposed project were to: (1) Investigate the relationships among perinatal depression, stigma, social capital utilization, PMTCT adherence, and (2) Test a pilot intervention to treat perinatal depression and improve adherence to ARVs among HIV infected women in a resource-limited setting.
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.
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:
Principal Investigator: Steven Safren, PhD, ABPP
Funding Source: National Institute of Mental Health (NIMH)
Description: This is a 3-year study to investigate the efficacy of a cognitive behavioral intervention for adolescents with ADHD who are stabilized on medications but still show clinically significant residual symptoms. Self-report, parent-report, teacher report, and independent assessor (who will be blind to treatment condition) data will be used as outcomes.
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.
Principal Investigator: Lara Traeger, PhD
Funding Source: American Cancer Society
Project Number: ACS MRSG PCSM 1410701
Description: The goal of this study is to examine and address associations of depression, anxiety and adherence to long-acting opioids among adults with chronic cancer-related pain. Study procedures currently are integrated into ambulatory care at the Massachusetts General Hospital Cancer Center. In Project 1 (a prospective observational study), we will examine the extent to which depression and anxiety symptoms are associated with poorer opioid adherence and worse pain outcomes. In Project 2 (an open pilot trial), we will use our results to develop and test a structured intervention to help patients adhere to their opioid regimens while reducing depression and anxiety symptoms. This work has the potential to increase the benefits of guideline-based treatments for chronic cancer pain and to optimize quality of life for patients at high risk for crisis-oriented pain care.
See recent publications from the members of the Behavioral Medicine Program.
Note: * indicates a current or former member of the program
Batchelder, A.W., Foley, J.*, Wirtz, M.R.*, Mayer, K., O’Cleirigh, C.* Substance Use Stigma, Avoidance Coping, and Missed HIV Appointments among MSM who Use Substances. AIDS and Behavior (in press).
Hall DL*, Millstein RA*, Luberto CM*, Perez G*, Park ER*. Responding to COVID-19 stress: Disseminating mind-body resiliency approaches. Global Advances in Health and Medicine. In Press.
Hall DL*, Park ER*, Cheung T, Davis RB, Yeh GY. A pilot mind-body resiliency intervention targeting fear of recurrence among Cancer survivors. Journal of Psychosomatic Research. In press.
Hall DL*, Peppercorn JM. Wake Up Oncologists! It’s Time to Help our Patients with Insomnia. Journal of the National Comprehensive Cancer Network (JNCCN). In press.
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