Research in Behavioral Medicine
Domestic Research Projects
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.
National HIV Behavioral Surveillance
Site Principal Investigator: Conall O’Cleirigh, PhD
Funding Source: Centers for Disease Control and Prevention (CDC)
Description: 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:
- Gay, bisexual, and other men who have sex with men (MSM) [2017,2020] Persons who inject drugs (IDU) [2018, 2021] Heterosexuals at increased risk for HIV infection (HET) [2019, 2022]
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.
PrEP and MOUD Rapid Access for Persons who inject Drugs: the CHORUS Study
Principal Investigator: Christina Psaros, PhD
Funding Source: National Institute of Drug Abuse (NIDA)
Project Number: 1R01DA058367-01
Description: The current proposal seeks to determine the efficacy of a novel intervention to increase the uptake of evidence-based measures to prevent HIV and treat opioid use disorder. We will compare the CHORUS+ intervention to usual care (passive referral) among persons who inject opioids (aim 1). In addition, we will examine study implementation to facilitate potential future dissemination using a mixed-methods process evaluation of CHORUS+ (aim 2).
Potential Participants: Not yet recruiting.
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, and 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: No longer recruiting.
Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care
Principal Investigators: Steven Safren, PhD, ABPP and Kenneth Mayer, MD
Co-Investigator: Christina Psaros, PhD
Funding Source: National Institute of Health (NIH)
Project Number: R01 MH118043
Description: In this 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 open to enrollment.
Mindfulness and Behavior Change to Promote Cardiovascular Health in Older People with HIV (One-Mind One-Heart)
Principal Investigator: Jacklyn Foley, PhD
Funding Source: National Heart Lung and Blood Institute (NHLBI)
Project Number: 5K23HL167650-02
Description: This study will establish the feasibility and acceptability of a novel, text-enhanced integrative behavioral intervention “One Mind-One Heart (OM-OH),” aimed at reducing cardiovascular disease (CVD) risk in older people with HIV (OPWH). By addressing CVD, a significant co-morbidity that affects a growing number of OPWH in psychological distress due to shared pathophysiology linked to systemic inflammation, this work will be instrumental in improving the health and well-being of PWH across the lifespan.
Potential Participants: Currently open to enrollment. See https://rally.massgeneralbrigham.org/study/one_mind_one_heart
Mindfulness and Cardiovascular Health among People with HIV (MI-HHEART)
Principal Investigator: Jacklyn Foley, PhD
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 open to enrollment. https://rally.massgeneralbrigham.org/study/mi_hheartquant
Harvard Center for AIDS Research: Engaging Structurally Disadvantaged MSM Who Use Stimulants in HIV Prevention
Principal Investigator: Jacklyn Foley, PhD
Funding Source: NIAID/NIMH Administrative Supplements to NIH Centers for AIDS Research (CFAR) and NIMH AIDS Research Centers (ARC) for Ending the HIV Epidemic (EHE)
Project Number: 5P30AI060354-20
Description: This study involves collaboration between clinical psychology researchers, Fenway Health leaders and staff, and structurally disadvantaged men who have sex with men (MSM) who use stimulants. We aim to identify critical barriers to HIV prevention services, and unmet (e.g., psychosocial, and structural) needs for structurally disadvantaged men who have sex with men (MSM) who use stimulants via in-depth qualitative interviews; select evidence-based intervention content (e.g., skill-building problem-solving and emotion-focused coping skills) to meet these needs; and refine the selected interventions, with provider key stakeholder feedback, to be optimized for implementation in Fenway Health.
Potential Participants: Currently open to enrollment. See https://fenwayhealth.org/studies/project-upgage/
Bridge to Belonging (B2B): Peer Led Intervention to Reduce Loneliness and Depression among Older Gay and Bisexual Men Living with HIV
Principal Investigators: Abigail Batchelder, MPH, PhD and Sean Cahill, PhD
Co-Investigator: Jacklyn Foley, PhD
Funding Source: National Institute on Aging
Project Number: 1R21AG087792-01
Description: The proposed study will develop and refine a novel evidence-informed intervention, Bridge 2 Belonging (B2B), to reduce depression and loneliness among older gay and bisexual men living with HIV (OGBMLH) by leveraging three evidence-based intervention strategies: cognitive behavioral therapy-based friendship enrichment program (FEP), motivational interviewing (MI) communication styles, and peer mentorship (PM). Guided by the ADAPT-ITT model, we will systematically solicit feedback on these interventions from OGBMLH and subsequently community experts (n=15) to iteratively inform an innovative peer-delivered B2B intervention to increase participation in LGBTQ+ affirmative community-building services to reduce symptoms of depression and loneliness, and secondarily improve physical health and quality of life.
Potential Participants: Currently open to enrollment. Please e-mail b2b@fenwayhealth.org for more details.
Leveraging mHealth to Develop Syndemic-Based Behavioral Medicine HIV Prevention for the Emergency Department to Reach Minoritized PWUD
Principal Investigator: Tiffany Glynn, PhD
Funding Source: National Institute on Drug Abuse
Project Number: 1K23DA060719-01
Description: Using implementation science, the goal of this project is to develop and test a behavioral medicine mHealth HIV prevention point-of-care intervention for the emergency department for minoritized people who use drugs.
Potential Participants: Currently open to enrollment.
Informing Development of a Tailored Intervention to Address Drug Use and Subsequent HIV Risk Among Transgender Women
Principal Investigator: Tiffany Glynn, PhD
Funding Source: Harvard Center for AIDS Research (CFAR) Developmental Award
Project Number: NIH/NIAID P30 AI060354
Description: This project aims to inform the development of a tailored drug use intervention for transgender women in the context of primary and secondary HIV prevention. This goal will be achieved via a sequential mixed-methods, community-informed approach.
Potential Participants: Currently open to enrollment. Please reach out to mghtransform@mgb.org for more information.
Proof of Concept for a Behavioral ART Adherence Intervention using Virtual Reality: Life-Steps VR
Principal Investigator: Tiffany Glynn, PhD
Funding Source: Ken Mayer Fellowship/The Fenway Institute at Fenway Health
Description: Explore proof-of-concept to adapt the evidence-based adherence intervention,
Lifesteps, for virtual reality to increase ART adherence among people who use drugs with HIV.
Potential Participants: Recruitment is anticipated to start in early 2025.
Closing the Gap in Ongoing Health Equity Research in the Emergency Department: Informing Psychosocial-Behavioral Integrated Care Development en Español
Principal Investigator: Tiffany Glynn, PhD
Funding Source: Mass General Brigham Emergency Medicine Award
Description: The overall goal of this proposal is to expand an ongoing HIV-related health equity research project in the Brigham and Women’s Hospital emergency department (ED) by including Spanish speakers to develop a culturally responsible mHealth intervention accessible to patients who speak Spanish.
Potential Participants: Recruitment is anticipated to start in early 2025.
Smart Steps: A Context-Aware Adherence Intervention to Improve PrEP Adherence among Men who Have Sex with Men (MSM) with Substance Use Disorder
Principal Investigator: Peter Chai, MS, MD
Funding Source: National Institute on Drug Abuse Avenir Award
Project Number: DP2DA056107
Description: Our current work has demonstrated that men who have sex with men (MSM) with substance use disorder (SUD) will accept and operate the digital pill system (DPS) to measure PrEP adherence and are willing to accept interventions that account for patterns of PrEP ingestion from the digital pill. This study aims to develop SmartSteps, a context aware, antecedent intervention that digests PrEP adherence data from the digital pill, and combine it with digital phenotyping to anticipate potential PrEP nonadherence. In the face of anticipated nonadherence SmartSteps will deliver empiric corrective feedback thereby mitigating PrEP nonadherence before it occurs. This proposal will consist of two phases. In phase I, we will inform the specification of an algorithm that utilizes smartphone digital phenotyping features (location, Bluetooth, charging, accelerometry, app usage, phone and text usage) to anticipate PrEP nonadherence annotated by the digital pill. We will utilize a digital phenotyping app, Beiwe, which securely and anonymously collects raw smartphone use data. We will recruit N=40 MSM with substance use to utilize the digital pill for PrEP adherence in concert with Beiwe over 60 days to generate a dataset that will be used to train the algorithm behind SmartSteps. In phase II, we will conduct a pilot randomized controlled trial of SmartSteps compared to treatment as usual among HIV negative MSM with substance use disorder with a primary outcome of understanding the potential for an effect of SmartSteps in mitigating nonadherence and improving both overall and weekly adherence.
Potential Participants: Currently open to enrollment.
Development of an Integrated mHealth App-Based Intervention to Support Smoking Cessation in People Living with HIV
Principal Investigators: Conall O’Cleirigh, PhD and 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 open to enrollment.
Effectiveness of a Smoking Cessation Algorithm Integrated into HIV Primary Care
Principal Investigators: Conall O’Cleirigh, PhD, Karen Cropsey, PhD, and Heidi Crane, MD
Funding Source: National Institute on Drug Abuse (NIDA)
Project Number: R01DA044112
Description: 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:
- Compare the efficacy of Algorithm Treatment to Enhanced Treatment as Usual for smoking cessation among PLWH who smoke engaged in HIV clinical care. Algorithm Treatment includes the generation of a pharmacotherapy prescription recommendation sent to the patient’s medical provider through the electronic medical record.
- Characterize provider-, staff-, patient-, and clinic-level facilitators and barriers to integration of Algorithm Treatment.
- Examine the cost effectiveness for the intervention relative to primary smoking outcomes.
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 open to enrollment.
Principal Investigators: Conall O’Cleirigh, PhD, Michael Zvolensky, PhD, and Jasper Smits, PhD
Funding Source: National Institute on Drug Abuse (NIDA)
Project Number: R01DA047933
Description: 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:
- Test the efficacy of the QUIT intervention plus Nicotine Replacement Therapy in people with HIV who smoke, using a 3-arm RCT. QUIT is a cognitive-behavioral-based intervention to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities.
- Examine the degree to which smoking abstinence is mediated by reductions in symptoms of anxiety and depression.
- Estimate the cost-effectiveness of the QUIT intervention for smoking cessation among people living with HIV who smoke with clinically significant symptoms of anxiety/depression.
Potential Participants: Currently open to enrollment.
Assessing the Integration of Tobacco Cessation Treatment into Lung Cancer Screening (Screen ASSIST)
Principal Investigators: Elyse R. Park, PhD, MPH, Nancy A. Rigotti, MD, and 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 open to enrollment.
Implementing a Virtual Tobacco Treatment in Community Oncology Practices (Smoke Free Support Study 2.0)
Principal Investigator: Elyse R. Park, PhD, MPH and 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: No longer recruiting.
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 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 Perez Lougee, 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.
Understanding and Improving Health Insurance Coverage Among Long-Term Follow-up Study Cohort Participants / HINT I
Principal Investigators: Elyse Park, PhD and Giselle Perez Lougee, PhD
Funding Source: American Cancer Society (ACS)
Project Number: RSGI-18-135-01
Description: 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.
Building Resiliency Among Caregivers of Curvivors and Metavivors: A Pilot randomized Trial
Principal Investigators: Elyse R. Park, PhD, MPH and Areej El-Jawahri, MD
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: Currently open to enrollment.
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, PhD and Gina Kruse, MD
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 open to enrollment.
Developing a Mind-Body Intervention to Promote Sexual Well-Being of Female GI Cancer Survivors
Principal Investigators: Elyse Park, PhD, MPH and Lucy Finkelstein Fox, PhD
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: Currently open to enrollment for an open trial pilot.
Assessing the Effect of Virtual Navigation Interventions to Improve Health Insurance Literacy and Decrease Financial Burden / HINT II
Principal Investigators: Elyse Park, PhD and Giselle Perez Lougee, 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 open to enrollment.
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 and 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 open to enrollment.
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.
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 (FCR). FCR 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 FCR 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 FCR 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 FCR-related coping and healthcare engagement patterns. Phase 2 tested the feasibility of the adapted intervention in a pilot RCT and explored preliminary effects on FCR and healthcare engagement outcomes.
NCT.gov: https://clinicaltrials.gov/ct2/show/NCT04876599
Potential Participants: No longer recruiting.
Innovating CBT-I for Cancer Survivors: An Optimization Trial Principal
Principal Investigator: Daniel L. Hall, PhD
Funding Source: National Cancer Institute (NCI)
Project Number: 1R21CA279248-01A1
Description: This is a 2-year study aiming to conduct a randomized controlled trial evaluating the Survivorship Sleep Program delivered in four different ways (individual sessions + booster sessions, individual sessions + no booster sessions, group sessions + booster sessions, or group sessions + no booster sessions) among 80 cancer survivors with insomnia. Additionally, we will be enrolling a majority (>50%) racial and/or ethnic minority cancer survivors.. Racially and ethnically diverse cancer survivors are understudied in CBT-I trials. Even as there have been repeated calls for addressing sleep health disparities in cancer survivorship inclusion of American Indian/Alaska Native, Asian, Native Hawaiian/Pacific Islander, Black or African American, Multiracial, and Hispanic cancer survivors in CBT-I trials remains dismal. Fortunately, emerging research has found that CBT-I has similar effects on insomnia severity for Black vs. non-Hispanic white women, and comparably large effects for Hispanic cancer survivors. However, racially and ethnically diverse cancer survivors may face additional and/or unique barriers to accessing or completing CBT-I, as most programs were developed with predominantly non-Hispanic white samples when determining optimal delivery plans. Thus, there is a need to understand the feasibility, acceptability, and efficacy of synchronous, virtual CBT-I among these growing subgroups of cancer survivors.NCT.gov: NCT06181643
Potential Participants: Currently open to enrollment.
Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia across Phases of Cancer Survivorship
Principal Investigator: Daniel L. Hall, PhD
Funding Source: American Cancer Society (ACS)
Project Number: Research Scholar Grant
Description: This is a 4-year study aiming to conduct a randomized controlled trial evaluating the Survivorship Sleep Program compared to enhanced usual care among 198 cancer survivors with insomnia. We will be enrolling individuals who have competed primary cancer treatment, in active cancer treatment, and those living with metastatic cancer and not in treatment. Cancer survivors who are in treatment and metavivors are understudied in CBT-I trials, and emerging research suggests that CBT-I may also be helpful for survivors across the phases of survivorship, including survivors who are currently in treatment and survivors who are living with metastatic cancer and not in treatment (i.e., metavivors). 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.
NCT.gov: N/A
Potential Participants: Recruitment will begin on 3/1/25.
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 617-724-1414
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. In Phase 1 of the study, we conducted interviews with young adult couples to collect feedback on a couples- based intervention including the delivery, timing, and content of the program. We have developed a virtual, eight-session 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 caregivingresearch@mgh.harvard.edu or 857-600-0315.
Principal Investigators: 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: No longer recruiting.
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.
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.
Exploring Oncology Providers’ Attitudes Toward Cancer Clinical Trials
Principal Investigator: Giselle Perez Lougee, PhD
Funding Source: Lazarex-Mass General Cancer Care Equity Program
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.
A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors
Principal Investigator: Giselle 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:
- Adapt a mind-body resiliency group intervention for AYAs (3RP-AYA) that is aimed at reducing stress and promoting stress- management during the post-treatment transitional period
- Conduct an open pilot (n=8) to test and refine the 3RP-AYA
- Examine, in a pilot randomized controlled trial (n=60), the feasibility, acceptability, and preliminary effects of a virtual, group-based, stress-management program for AYAs who are in the early stages of survivorship; and 3b) explore the feasibility and acceptability of collecting hair samples to examine intervention-related changes in stress as measured by cortisol.
Potential Participants: No longer recruiting.
Promoting Stress Management and Resiliency Among Lymphoma Survivors Transitioning Off Treatment
Principal Investigator: Giselle 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.
Examining Sexual Minority Engagement in Recovery Community Centers
Principal Investigator: Abigail Batchelder, PhD, MPH
Co-Investigator: Jillian Scheer, PhD, John Kelly, PhD, and Bettina Hoeppner, MS, PhD
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: Currently enrolling participants. See https://rally.massgeneralbrigham.org/study/rcc.
The Daily Effects of Trauma and Minority Stress among Sexual Minority Women with Post-Traumatic Stress Symptoms
Principal Investigators: Jillian Scheer, PhD
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, PhD
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 Investigator: Abigail Batchelder, PhD, MPH
Co-Investigators: Jennifer Potter, MD and Jenna Morris, MD
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.
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.
Potential Participants: No longer recruiting. To learn more about this study, please contact the study coordinator at mscully@mgh.harvard.edu
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 open to enrollment.
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)
Effectiveness of Interventions to Improve Resiliency and Burnout in Behavioral Health Residential Staff
Principal Investigators: Stephen Bartels, MD, MS and Giselle Perez, PhD
Co-Investigator: Christina Psaros, PhD
Funding Source: Patient Centered Outcomes Research (PCORI)
Project Number: IHS-2022C1-26444
Description: This project plans to conduct a practical research trial comparing two different system-level approaches to improving Residential Care Workers well-being and resiliency to reduce burnout and staff turnover: (1) a microsystem intervention (group home level) of integrated resiliency training and task sharing (IRTTS) and (2) a mesosystem intervention (organization level) intervention of a virtual workplace improvement learning collaborative (WILC) aimed at reducing administrative burdens and increasing workflow efficiencies.
Potential Participants: Currently open to enrollment.
Promoting Resiliency and Mental Health Among Health Professional Workforce
Principal Investigators: Watura Finley and Gaurdia Banister, PhD
Co-Investigators: Elyse R. Park, PhD, MPH and Louisa Sylvia, PhD
Funding Source: US 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 open to enrollment.
Promoting Resiliency among SIBLINGS of Children with Autism Spectrum Disorder (ASD)
Principal Investigators: Karen Kuhlthau, PhD and Elyse R. Park, PhD, MPH
Funding Source: US Health Resources and Services Administration (HRSA)
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.
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 and Elyse R. Park, PhD, MPH
Funding Source: US Health Resources and Services Administration (HRSA)
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.
For more information, please email Lucy Fell (lfell@mgh.harvard.edu).
Mind-Body Resiliency Data Repository
Principal Investigator: Elyse R. Park, PhD, MPH
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.
For more information, please email Lucy Fell (lfell@mgh.harvard.edu & awrasmussen@mgh.harvard.edu)
Recently Completed Domestic Research Projects
Development of a Trauma-Informed Intervention to Support Adaptive Engagement in Care among MSM
Principal Investigators: Conall O’Cleirigh, PhD and 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:
- Test the feasibility and acceptability of a psychosocial intervention to improve engagement in HIV care, HIV medication adherence among MSM living with HIV with trauma histories. The intervention integrates most current empirically supported cognitive-behavioral approaches to support engagement in HIV care (i.e., LifeSteps) with cognitive-processing therapy, an empirically validated, cognitive-behavioral intervention for reducing posttraumatic stress.
- Examine, in a pilot randomized controlled trial, the impact of the proposed intervention for MSM with trauma history on improvement in engagement in HIV care, adherence to HIV treatment, (primary outcomes) and reductions of sexual transmission risk taking behaviors (secondary outcome).
- Explore whether intervention related changes in trauma-specific distress, will mediate intervention related changes in increases in engagement in care and ART adherence.
This project is being conducted at Fenway Health in Boston, MA and Ryerson University in Toronto, Canada.
This project was conducted at Fenway Health in Boston, MA and Ryerson University in Toronto, Canada.
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 and Steve Safren, PhD, ABPP
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.
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 Investigators: Lisa Hightow-Weidman, MD, MPH and Patrick Sullivan, PhD
Project Principal Investigators: Christina Psaros, PhD and Kenneth Mayer, MD
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.
PrEP Demonstration Project Among Women at Risk for HIV Infection
Co-Principal Investigators: Christina Psaros, PhD and Mirjam Kempf, PhD, MPH
Funding Source: National Institute of Mental Health (NIMH)
Project Number: 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.
Please contact ottcm@uab.edu for more information.
Developing a Resilience Intervention for Older, HIV-Infected Women
Principal Investigator: Christina Psaros, PhD
Funding Source: National Center for Complementary and Integrative Health (NCCIH)
Project Number: 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.
Promoting Resiliency among Parents of Children with Learning and Attention Disabilities (LD)
Principal Investigator: Elyse R. Park, PhD, MPH
Funding Source: The Marino Foundation
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.
Promoting Resiliency Among Parents of Children with Autism Spectrum Disorder (ASD)
Principal Investigator: Karen Kuhlthau, PhD
Co-Investigator: Elyse R. Park, PhD, MPH
Funding Source: US Health Resources and Services Administration (HRSA)
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.
For more information, please email ParentalStressStudy@partners.org, or contact Emma Chad-Friedman at 617-643-6036.
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, PhD, MPH
Co-Investigator: Jacklyn Foley, PhD
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.
