RECOVERING TOGETHER: BUILDING RESILIENCY IN DYADS OF PATIENTS ADMITTED TO THE NEUROSCIENCE INTENSIVE CARE UNIT (NICU) AND THEIR CAREGIVERS (R01NR019982)

Principal Investigator: Ana-Maria Vranceanu, PhD
Project Director: Victoria Grunberg, PhD and Alex Presciutti, PhD, MSCS
Study Clinicians: Christina Rush, PhD, Julia Hooker, PhD, Kirsten Klein, MS, Darby Simon, MS, Nicolás Alvarez Frank
Study Coordinator: Claire Szapary, MPH
Funding Source: National Institute of Nursing Research

This is a fully powered, efficacy RCT testing two behavioral programs (Recovering Together-1 and Recovering Together-2) to prevent chronic emotional distress in dyads of patients with an acute brain injury (e.g., stroke, TBI) and their family caregivers. The programs support dyads from hospitalization in the Neuro-ICU through discharge home or to rehab.

Study Status: Actively Recruiting

For more information, please contact Claire Szapary (cszapary@mgh.harvard.edu)

LIVE VIDEO MIND-BODY TREATMENT TO PREVENT PERSISTENT SYMPTOMS FOLLOWING MTBI (1K23AT010653-01A1)

Principal Investigator: Jonathan Greenberg, PhD
Study Clinician: Jonathan Greenberg, PhD
Study Coordinator: Nadine Levey, BA
Funding Source: National Center for Complementary and Integrative Health

This study will establish the feasibility, acceptability, and credibility of a novel, live video mind-body program (i.e., Toolkit for Optimal Recovery after Concussions) aimed at preventing persistent symptoms and optimizing recovery following mild traumatic brain injury (mTBI) among young individuals (ages 18-35) with mTBI and anxiety. This study is currently conducting an RCT (Phase 3) comparing two programs designed specifically for this population (TOR-C1 and TOR-C2). Both programs aim to improve recovery following a concussion.

Study Status: Data Analysis

For more information, please contact Nadine Levey (nlevey@mgh.harvard.edu)

RESILIENCY TRAINING FOR ADOLESCENTS WITH NF1 AND NF2 VIA LIVE VIDEOCONFERENCING (W81XWH1910184)

Principal Investigator: Ana-Maria Vranceanu, PhD
Project Director: Heena Manglani, MA
Study Coordinator: Claire Szapary, MPH
Funding Source: Department of Defense

This fully powered single blind, virtual RCT compares 2 live video resiliency programs to determine which one better improves quality of life among adolescents with NF1 or NF2. Secondary outcomes include pain, pain interference, coping, mindfulness, depression, and anxiety.

Study Status: Actively Recruiting

For more information please contact Claire Szapary (cszapary@mgh.harvard.edu)

ACTIVE BRAINS: MANAGING PAIN AND COGNITIONS IN OLDER ADULTS WITH MILD COGNITIVE IMPAIRMENT (MCI) OR MEMORY RELATED PROBLEMS (MRP) AND CHRONIC PAIN (R01AG075899)

Principal Investigator: Ana-Maria Vranceanu, PhD
Co-Investigator & Study Manager: Ryan Mace, PhD
Study Coordinators: Defne Yucebas and Elizabeth Rochon, BA
Funding Source: National Institute on Aging

This fully powered, single blind, remote RCT compares two symptom management groups (Active Brains 1 and Active Brains 2). Our goal is to improve multimodal physical, cognitive, and emotional functioning among older adults with chronic pain and early subjective or objective cognitive decline. We will also test sustainability of improvement over 6 months and mechanisms of improvement through mediators and moderators.

Study Status: Actively Recruiting

For more information, please contact Defne Yucebas (dyucebas@mgh.harvard.edu)

RESILIENT FAMILIES (R-FAM): A DYADIC RESILIENCY INTERVENTION FOR PARENTS OF BABIES IN NEONATAL INTENSIVE CARE

Principal Investigator: Victoria Grunberg, PhD
Study Clinician: Victoria Grunberg, PhD
Study Coordinator: Julia Davis
Funding Source: National Institute of Child Health and Development

This study aims to adapt a dyadic intervention for parent couples who have babies in neonatal intensive care. We will: (1) develop R-FAM based on stakeholder input (interviews) and the Recovering Together intervention; (2) optimize R-FAM through an open pilot; and (3) test for R-FAM feasibility and acceptability in a pilot RCT. The goal of this intervention is to reduce parental emotional distress and improve family relationships. We hope to test R-FAM eficacy-effeciveness in future trials.

Study Status: Actively Recruiting

For more information, please contact our study team (parentsupportstudy@mgh.harvard.edu)

HEALTHY ACTIVITY IMPROVES LIVES (HAIL) (1R21AG067091-01A1)

Principal Investigators: Louisa Sylvia, PhD & Ana-Maria Vranceanu, PhD
Project Director: Roberta Tovey, PhD
Study Clinicians: Sarah Bannon, PhD
Study Coordinators: Antonietta Alvarez Hernandez, Ariana Sofia Gonzalez Montinola
Funding source: National Institute on Aging

This study aims to adapt the evidence based-Fit and Strong! (F&S!) program to help engage older Black adults in sustained physical activity. We have partnered with the Black Ministerial Alliance of Greater Boston (BMA), an organization of predominantly Black churches, to conduct focus groups to better understand key barriers to engaging in physical activity in this population, and to gather impressions of an online platform to encourage sustained physical activity. We are currently developing an adjunct, online platform to the F&S! program and will be running an open pilot study (N=30) across BMA-affiliated churches to examine the feasibility and acceptability of the F&S! Online program.

Study Status: Conducting focus groups, building the platform

For more information, please contact Antonietta Alvarez Hernandez (aalvarezhernandez@mgh.harvard.edu)

My Healthy Brain: a mindfulness-based lifestyle intervention to modify early risk of dementia in older adults (1K23AG075257-01)

Principal Investigator: Ryan Mace, PhD
Study Coordinator: Makenna Law, BS
Funding source: National Institute on Aging

This K23 project will establish the feasibility of a mindfulness-based lifestyle program, My Healthy Brain (MHB), to modify multiple risk factors dementia in older adults with subjective cognitive decline. We will conduct focus groups with medical stakeholders (N = 20) and a feasibility randomized clinical trial (RCT) of the MHB program (N = 50). This data will inform a larger efficacy trial of the MHB program, which we hope to scale with mobile health technology to widely engage older adults in healthy lifestyles with aging.

Study Status: Actively Recruiting for the Randomized Clinical Trial

For more information, please contact Makenna Law (mlaw@mgh.harvard.edu)

Improving multimodal physical function in adults with heterogeneous chronic pain; Multi-site feasibility RCT (1Ro1At012069-01)

Multiple Principal Investigators: Ana-Maria Vranceanu, PhD & Jonathan Greenberg, PhD
Study Clinician: Julia Hooker, MS
Study Coordinators: Dany La Camera, BA and Claire Szapary, MPH
Study Sites: Massachusetts General Hospital, Duke University, & Rush University
Funding Source: National Center for Complementary and Integrative Health

This study aims to evaluate the multi-site feasibility of two behavioral programs for adults with chronic musculoskeletal pain. We are testing fidelity of training and implementation and assessing feasibility benchmarks of these programs at 3 locations: Massachusetts General Hospital, Duke University, & Rush University. We will enroll 90 participants across 3 sites for this study. We will then refine our procedures in preparation for a future fully powered multisite randomized controlled efficacy trial.

Study Status: Data Analysis

For more information, please contact Dany La Camera at (dlacamera@mgb.org)

iHOPE: A mind-body and activity program aimed at improving physical and emotional function among older adults in underserved communities with chronic pain; a multimodal RCT (GetActive+) (1R61AG081034-01)

Principal Investigators: Ana-Maria Vranceanu, PhD & Christine Ritchie, MD, MSPH
Project Directors: Jonathan Greenberg, PhD & Katherine McDermott, PhD
Study Coordinators: Clara Vonderheide, BA
Funding Source: National Institute on Aging

This study aims to optimize and implement our mind-body and activity program, GetActive, for older adults experiencing chronic musculoskeletal pain from underserved community health centers. In the R61 phase, we will conduct focus groups with stakeholders and patients, followed by an open pilot (N=30) to assess the feasibility and acceptability of the new program (GetActive+). Feedback received will be used to refine and finalize the approach for the R33 phase, a randomized hybrid type 1 trial evaluating the effectiveness and implementation of GetActive+. We will enroll 200 participants for this study. Both phases will take place at the MGH-Revere HealthCare Center (RHC), which serves a diverse and underserved community in Revere, Massachusetts. The overarching goal of the HEAL project is to incorporate GetActive+ into the daily operations of underserved health centers across the region and nation.

Study Status: Data Analysis

For more information, please contact Clara Vonderheide (cvonderheide@mgh.harvard.edu)

stride: Using Mobile Technology to Reduce Stress in Caregivers of Persons with Dementia. A Scalable Solution to A Growing Problem (R21 AG075187-01A1)

Principal Investigators: Ana-Maria Vranceanu, PhD & Jennifer Huberty, PhD
Study Coordinators: Morgan Seward, BA
Funding Source: National Institute on Aging 

This study aims to evaluate the feasibility and proof of concept of two consumer-based mobile applications in decreasing stress, emotional distress, and sleep dysfunction in informal caregivers of persons with Alzheimer's disease and related dementias. Participants are randomized to one of two apps and complete guided listening for 10 minutes/day for 12 weeks. We recruited N=93 participants.

Study Status: Not Recruiting

For more information, please contact Morgan Seward (mseward1@mgh.harvard.edu)

TEND: Toolkit for Experiential well-being in Dementia (78597)

Principal Investigators: Christine Ritchie, MD, MSPH & Ana-Maria Vranceanu, PhD
Study Clinician: Evan Plys, Ph.D
Study Coordinators: Elizabeth Rochon, BA & Ayush Thacker, BS
Funding Source: Robert Wood Johnson Foundation

This study aims to develop a novel approach to supporting wellness among persons living with dementia and their caregivers (dyads) through the application of bio-experiential design developed by our collaborative partners, Studio Elsewhere. We will (1) conduct multiple focus groups with clinicians, persons living with dementia, and caregivers to assess the safety of a bio-experiential platform; (2) conduct multiple workshops with persons living with dementia and caregivers to assess the user-friendliness of a refined prototype and; (3) launch an open pilot with (N = 5) dyads to assess usability, engagement, and interest in the bio-experiential platform. We will learn from this study how bio-experiential and serious gaming technology may support wellbeing among persons with dementia and caregiver dyads in the home.

Study Status: Data Analysis

For more information, please contact Elizabeth Rochon (erochon@mgh.harvard.edu)

Resilient Together ALS: Building Resiliency in Dyads of People with ALS and their Caregivers

Principal Investigators: Christina Rush, PhD
Study Clinician: Christina Rush, PhD
Study Coordinator: Morgan Seward, BA
Funding Source: The ALS Association and the National Palliative Care Research Center

We seek to gather qualitative feedback from people with ALS, their care-partners, and ALS healthcare clinicians to create a biopsychosocial spiritual adaptation of the Recovering Together resiliency intervention (PI:  Vranceanu, R01NR019982) for people with ALS and their care-partners. Data will inform development and open pilot testing of the Resilient Together ALS intervention with the aim to improve adjustment among patients with ALS and their care-partners.

Study Status: Actively Recruiting

For more information, please contact Morgan Seward (mseward1@mgh.harvard.edu)

MASC: The Mindful and Self-Compassionate Care Program; Reducing Stress for Caregivers of Persons with Dementia (1R01AG078204-01)

Principal Investigators: Christina Ritchie, MD, MSPH & Ana-Maria Vranceanu, PhD
Study Coordinator: Aniyah Travis, BA
Funding Source: National Institute on Aging

This study aims to develop, optimize and establish proof of concept for the Mindful, Self-Compassionate Care Program (MASC) for stressed caregivers of persons with ADRD with challenging behaviors. In aim 1, we will use qualitative focus groups to develop MASC (NIH stage 1A; up to 30 caregivers; n=4 groups). In aim 2, we will optimize MASC and conduct an open pilot with exit interviews to explore feasibility benchmarks, target engagement and signal of improvement in stress, depression, anxiety and well- being (NIH stage 1A; up to 10 caregivers; n=1 group). In aim 3, we will conduct a pilot RCT of MASC versus a Health Education control to establish feasibility benchmarks and preliminary efficacy and explore evidence for potential mechanisms of improvement through the proposed mechanistic targets (N=80/c0 completers).  MASC combines evidence- based skills from mindfulness programs, self-compassion programs, and behavioral management programs to facilitate uptake, skill practice, and sustainability of improvements. The overarching goal of this project is to disseminate and implement MASC to reduce stress among all in need caregivers of persons with ADRD.

Study Status: Start-Up

For more information, please contact Aniyah Travis (atravis1@mgh.harvard.edu)

INSTILL: INterventions for Stressful Transitions in Later Life

Principal Investigators: Evan Plys, PhD
Study Coordinator: Makenna Law, BS & Morgan Seward, BA
Funding Source: The Ki Sub Joung Innovative Junior Faculty Pilot Award in Aging and Palliative Care (MGH Internal)

This study will build partnerships with skilled nursing facilities and establish a community advisory board to co-design a psychosocial intervention for older adults receiving nursing home-based post-acute rehabilitation care as well as their family care-partners (i.e., family dyads), with an emphasis on socioeconomically under-resourced families. We will (1) conduct qualitative interviews with Medicaid-eligible older adults and their family care-partners skilled nursing facilities to identify psychosocial treatment preferences; (2) conduct focus groups with skilled nursing facility staff to identify workflows for psychosocial intervention; and (3) convene a community advisory board of clinicians and other persons with relevant lived experience to collaboratively develop an intervention for family dyads in skilled nursing facilities.

Study Status: Data Analysis

First Year of Multiple Sclerosis in the MS Dyad (2022A012374)

Principal Investigator: Heena Manglani, PhD
Study Coordinators: Anastasia Prussakova & Ariel Emrani
Funding Source: International Neuropalliative Care Society

This online study aims to learn about the experiences and needs of people with multiple sclerosis and their care partners (e.g., spouse, family member, close friend) early after diagnosis. We will enroll 100 MS dyads: newly diagnosed people with MS (< 3 months) and their loved ones. Participants will be asked to complete surveys at enrollment and 6 months later, and some participants will be invited to participate in focus groups to share their experiences, challenges, and barriers to whole health care. Results from this study will be used to develop an intervention for MS dyads in the early period after diagnosis.

Study Status: Actively Recruiting

For more information, please contact Anastasia Prussakova (msdyad@mgb.org)

RECOVERING TOGETHER AFTER CARDIAC ARREST: A DYADIC MIND-BODY INTERVENTION FOR EMOTIONAL DISTRESS IN CARDIAC ARREST SURVIVORS AND THEIR INFORMAL CAREGIVERS (K23AT012487)

Principal Investigator: Alexander Presciutti, PhD, MSCS
Study Coordinators: Dany La Camera, BA
Funding Source: National Center for Complementary and Integrative Health

This study aims to develop a dyadic mind-body intervention for emotional distress in cardiac arrest survivors and their caregivers, “Recovering Together after Cardiac Arrest” (RT-CA). We will: (1) develop RT-CA content and study procedures based on interviews and focus groups with dyads and key stakeholders, (2) refine RT-CA through an open pilot, and (3) test the feasibility and acceptability of RT-CA through a pilot randomized controlled trial.

Study Status: Actively recruiting for the open pilot.

For more information, please contact Dany La Camera, BA (dlacamera@mgb.org)

Development and feasibility of a mind-body intervention to improve physical activity for patients with chronic hip pain

Principal Investigator: Kate Jochimsen, PhD, ATC
Funding Source: National Center for Complementary and Integrative Health

This study aims to develop a multi-modal psychological skills intervention (Helping Improve PSychological health: HIPS) for patients with chronic, non-arthritic hip pain. We will: (1) develop the HIPS intervention based on stakeholder input (focus groups); (2) optimize HIPS through an open pilot; and (3) test the feasibility, acceptability, and satisfaction of the HIPS intervention in a pilot RCT.

Study Status: Actively Recruiting

For more information, please contact Dr. Kate Jochimsen (kjochimsen@mgh.harvard.edu)

WEB-BASED MIND-BODY TREATMENT TO ENHANCE RESILIENCE AMONG PATIENTS WITH PAINFUL NONTRAUMATIC UPPER EXTREMITY CONDITIONS AND COMORBID RISKY SUBSTANCE USE (1K23AT012364-01)

Principal Investigator: Jafar Bakhshaie MD, PhD
Study Coordinator: Nadine Levey, BA
Funding Source: National Center for Complementary and Integrative Health

This study will establish the feasibility, acceptability, and credibility of a novel, asynchronous web-based mind-body program (i.e., Toolkit for Resilient Life beyond Pain and Substance Use) aimed at decreasing disability, pain, emotional distress, and prescription opioid/other substance dependence among patients who seek care for non-traumatic painful upper extremity conditions with comorbid risky substance use. This study has completed aim I (qualitative interviews with stakeholders) and is currently analyzing this data and preparing to launch the feasibility open pilot (n=Up to 12).

Study Status: Actively Recruiting

For more information, please contact Nadine Levey (nlevey@mgh.harvard.edu)

Mindfulness-based cognitive therapy for the chronic pain-depression co-morbidity among older Black individuals in the community; The Quiet Focus study (1K23AT012363-01)

Principal Investigators: Tony V Pham, MD, MScGH
Study Coordinators: Nomin Enkhtsetseg, BA and Mary Nzeyimana, BA
Funding Source: National Center for Complementary and Integrative Health, The Mongan Institute Center for Aging and Serious Illness

This study aims to adapt mindfulness based cognitive therapy (MBCT) for the chronic pain and depression needs of older Black Americans. We will adapt MBCT using guidance from the older Black community with co-occurring chronic pain and depression. We will then pilot the adapted MBCT ("Quiet Focus") and conduct a pilot RCT to assess for feasibility and acceptability. These proposed efforts will inform an efficacy trial as well as future studies aimed at generalizing this work to other underrepresented groups.

Study Status: Actively Recruiting

For more information, please contact Tony V Pham (tonyvpham@mgh.harvard.edu)

Culturally Adapting mindfulness based cognitive therapy for Black older adults with comorbid early cognitive decline and chronic pain; The Feeling of Being study (P30AG083196, UM1TR004408)

Principal Investigators: Tony V Pham, MD, MScGH
Study Coordinators: Nomin Enkhtsetseg, BA and Mary Nzeyimana, BA
Funding Source: National Institute on Aging, National Center for Advancing Translational Sciences

This study aims to culturally adapt mindfulness based cognitive therapy for the treatment needs and preferences of older Black adults with chronic pain and early cognitive decline. We will gather feedback about mindfulness-based cognitive therapy via qualitative focus groups with the central goal of finalizing a manual and study procedures. We will then conduct a feasibility open pilot study of the culturally adapted mindfulness-based cognitive therapy “Feeling of Being” to further assess for feasibility and acceptability.

Study Status: Actively Recruiting

For more information, please contact Tony V Pham (tonyvpham@mgh.harvard.edu)

BRISK: BUILDING RESILIENCE IN SKILLED NURISNG CARE (K23AG078410)

Principal Investigator: Evan Plys, PhD
Study Coordinators: Makenna Law, BS & Morgan Seward, BA
Funding Source: National Institute on Aging

This study will develop and pilot test a dyadic intervention to reduce depression and anxiety among Medicaid beneficiaries receiving rehabilitation care in a community nursing home (skilled nursing facility) and their primary care-partner. Specifically, we will: (1) iteratively develop the BRISK intervention through feedback from skilled nursing facility residents and their care-partners as well as a community advisory board; and (2) test the feasibility and preliminary clinical benefit in a pilot randomized controlled trial.

Study Status: Start-up

For more information, please contact Evan Plys, PhD (eplys@mgh.harvard.edu)

THE COMA FAMILY PROGRAM: A RESILIENCE PROGRAM FOR CAREGIVERS OF PATIENTS WITH SEVERE ACUTE BRAIN INJURIE

Principal Investigators: Alexander Presciutti, PhD, MSCS and David Hwang, MD
Study Coordinator: Elizabeth Rochon, BA
Funding Source: Neurocritical Care Foundation

This multi-site study aims to refine a resilience intervention for emotional distress in caregivers of patients with severe acute brain injuries. We are currently refining the intervention through an open pilot to prepare for feasibility testing

Study Status: Actively recruiting for the open pilot.

For more information, please contact Elizabeth Rochon, BA (erochon@mgh.harvard.edu)

Psychophysical and Neural Mechanisms Contributing to Chronic Postsurgical Pain in Adolescents and Adults

Principal Investigator: Christine B. Sieberg, PhD, EdM, MA
Study Clinician: Christine B. Sieberg, PhD, EdM, MA
Study Coordinators: Caitlin Curry, BA & Margaret Moreland, BA
Study Post Doctoral Fellow: Ziyan Wu, PhD
Funding Source: National Institute of General Medical Sciences

This grant has two projects: (1) A prospective study (pre & post-surgery) examining the biobehavioral and neural mechanisms contributing to chronic postsurgical pain (CPSP) through the lifespan. We enroll participants who are presenting for surgery and use a variety of behavioral and biological measures, as well as neuroimaging, to gain an understanding of the biological and psychological factors that contribute to the development of CPSP. (2) A mechanistic clinical trial of a group behavioral intervention based on Acceptance and Commitment Therapy (ACT). Participants are ages 12 and older and living with CPSP. They are randomized to complete the intervention or to treatment as usual. Participants complete behavioral and biological measures, including neuroimaging, in order to understand the potential mechanisms that contribute to treatment response in patients with CPSP.

Study Status: Actively recruiting individuals presenting for surgery, individuals with chronic post-surgical pain, and healthy (pain-free, surgery-free controls).

For more information, please contact mghpspresearch@mgb.org

COMORBIDITY OF CHRONIC PAIN AND EARLY COGNITIVE DECLINE AMONG OLDER, COMMUNITY-BASED BLACK ADULTS: COMPARATIVE EFFECTIVENESS TRIAL; HABIT: HEALTHY AGEING AS BLACK ADULTS: IN IT TOGETHER

Principal Investigators: Olivia Okereke, MD, MS, & Ana-Maria Vranceanu, PhD
Co-Principal Investigators: Karen T. Craddock, PhD, EdM, Jeanette Callahan, MD, Fanta Atkinson, PhD, LMHC & Dita Obler, MS, LCGC
Study Coordinators: Fatima Fontes, BA & Mary Nzeyimana, BA
Funding Source: Patient-Centered Outcomes Research Institute (PCORI)

This is a comparative effectiveness trial comparing two previously developed, widely used, and effective programs – Mindfulness Based Cognitive Therapy with walking (MBCT+w) and Active Living Every Day (ALED). The study aims to determine which program is most effective at addressing the problem of comorbid Chronic Pain (CP) and Early Cognitive Decline (ECD) among older Black adults in the community. The study is observing improvements in health outcomes (physical, emotional, cognitive function) after the program ends and sustained gains in improvement after 6 months. The superior program will be implemented by community peer coaches in the Greater Boston area through a sustainability plan.

Study Status: Start-Up

For more information, please contact Fatima Fontes (ffontes@mgh.harvard.edu)

Development of "Face-Forward-Web": A novel web-based program targeting pain-related outcomes among patients with heterogeneous chronic orofacial pain

Principal Investigators: Jonathan Greenberg, PhD & Ana-Maria Vranceanu, PhD (MPIs)
Study Coordinator: Nadine Levey, BA
Funding Source: National Institute of Dental and Craniofacial Research

This project will develop, iteratively refine, and establish the feasibility, acceptability and credibility of Face-Forward-Web, the first psychosocial intervention developed through mixed-methods, tailored specifically for patients with heterogeneous chronic orofacial pain, and delivered through asynchronous web-platform.

Study Status: Starting up

For more information, please contact nlevey@mgh.harvard.edu

Pain Disengagement Training: A self-directed intervention for pain catastrophizing (K23AT012789)

Principal Investigator: Katherine McDermott, PhD 
Study Coordinator: Clara Vonderheide, BA
Funding Source: National Center for Complementary and Integrative Health

Overview: This study aims to develop, refine, and examine the feasibility of a self-directed mind-body intervention, Pain Disengagement Training (PDT), to reduce pain interference and depression in individuals with chronic musculoskeletal pain and pain catastrophizing. We will (1) conduct qualitative focus groups with individuals with chronic musculoskeletal pain and catastrophizing to evaluate treatment needs and investigate avenues of adaptation for PDT, (2) conduct an open pilot to determine the initial feasibility of the PDT intervention, and (3) conduct a randomized clinical trial to evaluate the feasibility and acceptability of PDT.

Study Status: Actively Recruiting

For more information, please contact Clara Vonderheide (cvonderheide@mgh.harvard.edu)