Active Studies

Principal Investigator: Ana-Maria Vranceanu, PhD
Co-Investigator & Study Manager: Ryan Mace, PhD
Study Clinicians: Dumichel Harley, PhD; Darby Simon, PhD
Study Coordinators: Aliya Hosford, 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.

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

Principal Investigator: Michael P. Williams, PhD  Study Coordinator: Ben Gordon, BS  Funding Source: National Center for Complementary and Integrative Health

Problematic social media use is a generational public health issue for emerging adults (aged 18-29 years) and is connected to a litany of negative health outcomes, notably anxiety. This K01-funded project through the National Center for Complementary and Integrative Health will establish the feasibility of the Healthy Minds Program for Emerging Adults (HMP-EA). HMP-EA is a digital mindfulness phone application that times nudges to users to participate in active mindfulness exercises during moments of social media binging. To build, test, and establish feasibility of HMP-EA we will conduct qualitative interviews with emerging adults (N=12-20), conduct a beta test and subsequent single-arm open pilot of the initial prototype of HMP-EA, before running a fully-powered feasibility randomized controlled trial of HMP-EA (N=50). The results of this project will inform a future R01-funded, full efficacy trial of HMP-EA. 

 Study Contact: Ben Gordon, bgordon5@mgh.harvard.edu 

Principal Investigator: Evan Plys, PhD
Funding Source: NEXT-STEPs Pilot

The goal of this study is to update the STAR-VA intervention for serious mental illness and community nursing homes, following the ADAPT-ITT framework and NIH Stage Model.

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

Principal Investigator: Evan Plys, PhD
Study Clinicians: Darby Simon, PhD
Study Coordinator: Sowmya Sridhar, BS
Funding Source: National Institute on Aging

This study will develop and pilot test a dyadic intervention to reduce depression among residents 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.

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

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
Project Manager: Mallory Morehead, MPH
Clinicians: Dumichel Harley, PhD
Study Coordinators: Adjoa Acquaah, BA; Mariam Ahmed, BA; Denise Taveras, 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.

For more information, please contact Mallory Morehead (mmorehead@mgb.org)

Principal Investigators: Tony V Pham, MD, MScGH
Co-Investigator: Robert Parker, ScD
Study Coordinator: TBD
Funding Source: National Institute on Aging (NIA) 

Learn More: Feeling of Being is an NIA-funded pilot randomized controlled trial for older Black adults living with chronic pain and memory-related changes, including changes in memory, attention, or other thinking skills. The study compares Feeling of Being, a mindfulness-based cognitive therapy program designed with these changes in mind, with the Health Enhancement Program.

Both programs were developed with community input, are delivered by trained peer instructors, and take place at a local community center. Eligible participants will be assigned by chance to one of the two programs.

The study will assess feasibility, acceptability, and delivery fidelity and estimate preliminary effects on physical function, pain, emotional well-being, and cognitive function.

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

Principal Investigator: Kate Jochimsen, PhD, ATC
Study Coordinator: Abby Kapoor, BA
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.

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

Principal Investigators: Jonathan Greenberg, PhD & Ana-Maria Vranceanu, PhD (MPIs)
Clinicians: Brenda Lovette, PhD, MS, CCC-SLP
Study Coordinators: TBD
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.

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

Principal Investigators: Victoria Grunberg, PhD & Christine Sieberg, PhD Study Coordinator: Sara Bogan, BS Funding Source: National Institutes of Health

This study aims to develop and test a mind-body group intervention for women with endometriosis-associated pain. We are currently conducting patient focus groups to inform the development of EASE-ENDO. Our next step will be to assess the feasibility and acceptability of the intervention.

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

Principal Investigators: Louisa Sylvia, PhD & Ana-Maria Vranceanu, PhD
Project Director: Roberta Tovey, PhD
Study Clinicians: Sarah Bannon, PhD
Study Coordinators: Antonietta Alvarez Hernandez, BA; Ariana Sofia Gonzalez Montinola, BA
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.

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

Principal Investigators: Ana-Maria Vranceanu, PhD & Christine Ritchie, MD, MSPH
Project Directors: Jonathan Greenberg, PhD & Katherine McDermott, PhD
Clinicians: Natalia Giraldo-Santiago, PhD, LCSW; Katherine Gnall, MS; Andrea Kurkul, NP
Study Coordinators: Aliya Hosford, BA; Jaden Trask, MS
Funding Source: National Institute on Aging

This study aims to optimize and implement our mind-body and activity program, GetActive+, for underserved English and Speaking-speaking older adults experiencing chronic musculoskeletal pain from MGH Revere community clinics. In the R61 phase, we conducted an open pilot (N=33) which exceeded feasibility and acceptability benchmarks. We are currently in the R33 phase, conducting a randomized hybrid type 1 trial evaluating the effectiveness and implementation of GetActive+ (N=200). The overarching goal of the NIH HEAL project is to incorporate GetActive+ into the daily operations of underserved health centers across the region and nation.

For more information, please contact Courtney Kilduff (ckilduff2@mgh.harvard.edu)

Principal Investigators: Tony V Pham, MD, MScGH
Study Coordinator: TBD
Funding Source: National Center for Complementary and Integrative Health (NCCIH)

Learn More: Quiet Focus is an NCCIH-funded study for older Black adults living with chronic pain and depression. The study compares Quiet Focus, a mindfulness-based cognitive therapy program, with the Health Enhancement Program.

Both programs were developed with community input, are delivered by trained peer instructors, and take place at a local community center. Eligible participants will be assigned by chance to one of the two programs.

The study will assess feasibility, acceptability, and delivery fidelity and estimate preliminary effects on pain, emotional well-being, and physical function.

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

Principal Investigator: Katherine McDermott, PhD 
Study Coordinator: Sara Bogan, BS
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.

For more information, please contact Sara Bogan (sbogan@mgh.harvard.edu)

Principal Investigators: Ana-Maria Vranceanu, PhD & Evan Plys, PhD Project Manager: Lena Stevens, PhD Project Coordinator: Makenna Law, BS Study Coordinators: Immaculate Kamau, BS and Adrianna Monzon-Osorio, BA Funding Source: Patient-Centered Outcomes Research Institute (PCORI)

Principal Investigator: Evan Plys, PhD Research Coordinator: Sowmya Sridhar, BS Funding Source: University of Massachusetts Chan Medical School & The Ki Sub Joung Innovative Junior Faculty Pilot Award in Aging and Palliative Care

The goal of this study is to test and refine an individual version of InSTILL, a dyadic psychological intervention designed to address common stressors and accommodate functional challenges experienced by older adults with high comorbidity burden and depression. In Aim 1, we will test the feasibility, acceptability, and fidelity of InSTILL-Individual with 20 short-stay skilled nursing facility residents with 5+ chronic conditions and comorbid depression symptoms. In Aim 2, we will test the preliminary clinical benefit of InSTILL-Individual for depression and mechanisms of action (i.e., life management skills, emotional regulation skills) at post-intervention and an 8-week follow up.

Principal Investigator: Ryan Mace, PhD
Study Clinicians: Dumichel Harley, PhD
Funding Source: Massachusetts Association of Council on Aging and Senior Center Directors, Inc

The goal of this study is to 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, delivered through three partner Councils on Aging (senior centers) in Massachusetts. We will conduct focus groups with older adults, staff, and leadership (N = 60) to inform delivery and implementation, and subsequently conduct a feasibility open pilot of the MHB program (N = 60).

Principal Investigators: Ana-Maria Vranceanu, PhD & Kate Jochimsen, PhD, ATC Site Pis: Kristin Archer PhD, DPT, David Ring MD, PhD, Trevor Lentz PT, PhD, MPH, Tony Pennuto, MS, ATC Study Coordinators: Abby Kapoor, BA; Aliya Hosford, BA Funding Source: NIH

Principal Investigator: Julia Hooker, PhD 
Study Coordinator: Caitlin Curry, BA
Funding Source: NCCIH/NIH

Overview: The proposed study will develop, iteratively refine, and assess the feasibility and acceptability of a novel 2-session mind-body intervention, the “Toolkit for Optimal Pain Management in the Emergency Department (TOPMED).” TOPMED aims to reduce the pain catastrophizing and pain anxiety that motivates individuals with chronic musculoskeletal pain to seek care in the emergency department (ED) for chronic pain. TOPMED has the potential to increase pain coping and pain-related resiliency, reduce pain catastrophizing and anxiety, and ultimately reduce repeated ED utilization for pain among individuals with chronic musculoskeletal pain.

For more information, please contact Julia Hooker (jhooker2@mgh.harvard.edu)

Principal Investigator: Ana-Maria Vranceanu, PhD
Project Director: Victoria Grunberg, PhD and Alex Presciutti, PhD, MSCS
Study Clinicians: Savannah Boyd, MS; Katherine Gnall, MS; Julia Hooker, PhD; Kush Mehta, MS; Malena Price, MSc; Christina Rush, PhD
Study Coordinators: Aliya Hosford, BA
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.

For more information, please contact Courtney Kilduff (ckilduff2@mgh.harvard.edu)

Principal Investigators: Ana-Maria Vranceanu, PhD ; Maggie Syme, PhD, Bradford Dickerson, MD
Project Manager: Donna Rusinak, BA
Study Clinicians: Savannah Boyd, MS; Kush Mehta, MS; Malena Price, MSc
Study Coordinators:‍ Study Coordinators: Rarinsri (Pin) Assakul, BS; Lily Munier, BA; Jaden Trask, MS ‍Funding Source: National Institute on Aging

This is a fully powered, efficacy RCT testing two behavioral programs (Resilient Together-Young Onset Dementia 1 (RT-YOD1) and Resilient Together-Young Onset Dementia 2 (RT-YOD2)) to prevent chronic emotional distress in dyads of patients recently diagnosed with Young Onset Dementia and their primary informal caregivers. We aim to 1) determine the efficacy of RT-YOD1 versus RT-YOD2 both delivered via live video, among dyads with YOD within 6 months of diagnosis 2) determine whether improvements in efficacy outcomes are maintained through follow-up. Primary outcome is dyadic emotional distress.  Secondary outcomes are: mindfulness, coping ability, dyadic coping, and quality of life for dyads and individual patients and caregivers 3) determine whether dependent improvement in emotional distress and quality of life are mediated by improvements in the putative mechanisms of action (mindfulness, coping ability,  dyadic coping) and modified by relevant demographic and clinical predictors. 

Contact Email: mghresilienttogetheryod@mgb.org

Principal Investigators: Christina Rush, PhD
Study Clinician: Christina Rush, PhD
Study Coordinator: Sara Bogan, BS
Funding Source: National Center for Complementary and Integrative Health (NCCIH)

This K23 study aims to develop, refine, and pilot a mind-body meaning intervention to prevent chronic emotional distress among patients with ALS and their care-partners: “Resilient Together ALS (RT-ALS). We will: 1) develop RT-ALS content and study procedures based on interviews and focus groups with dyads and interdisciplinary ALS healthcare providers, 2) refine RT-ALS content and methodology in an open pilot, and 3) test the feasibility and acceptability of RT-ALS in a pilot randomized controlled trial.

For more information, please contact Sara Bogan (sbogan@mgh.harvard.edu)

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

This study aims to develop and test a dyadic intervention for parent couples who have babies in neonatal intensive care. Currently, we are testing R-Fam for feasibility and acceptability in a pilot RCT. The goal of this intervention is to reduce parental emotional distress and improve parental relationships. We hope to test R-FAM efficacy-effectiveness in future trials.

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

Principal Investigator: Ana-Maria Vranceanu, PhD
Project Director: Heena Manglani, MA
Study Coordinator: Aliya Hosford, BA
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.

For more information please contact Amber Wolf (AWOLF9@bwh.harvard.edu)

Principal Investigator: Michael Samaan, PhD (University of Kentucky); Kate Jochimsen, PhD, ATC (MGH site PI)
Study Coordinator: Abby Kapoor, BA
Funding Source: Department of Defense

Aim: Quantify the muscular- and psychological-based factors associated with hip joint injury as well as the changes in hip joint loading patterns that occur during a loaded ruck task and relate these muscular, psychological and biomechanical factors to changes in hip joint pain and cartilage health during the loaded ruck.

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