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A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program
Enhancing Social Connection, Health, and Aging in Older Persons: A Pilot Randomized Trial of the Hopeful and Healthy Living (HHL) Program
Who can join
Ages 50 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 50 years or older, diagnosis of a serious mental illness, and a member of Center Club or Transitions of Boston Exclusion Criteria: Diagnosis of dementia or other progressive neurological disorder
About the study
The goal of this clinical trial is to learn if a novel psychosocial intervention is effective in helping adults over 50 with serious mental illness (SMI) increase their social connections and participate in more healthy lifestyle activities. The Hopeful and Healthy Living (HHL) intervention combines social skills training and training in cognitive self-management strategies in order to help older adults build healthy lifestyle and social routines. We predict that:
* Individuals who participate in the HHL intervention will improve more in perceived social support (i.e., what people get from relationships such as reliance, reassurance of worth, attachment) and loneliness at the 4-, 8-, and 12-month follow-up assessments than those who receive treatment as usual (TAU). * Individuals who participate in the HHL intervention will improve more in overall psychosocial functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. * Individuals who participate in the HHL intervention will improve more in cognitive functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. * Individuals who participate in the HHL intervention will improve more in healthy behaviors (sleep, activity, diet) at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU.
In this trial, participants will be either receive the HHL intervention or participate in their regular treatment activities (treatment as usual). HHL vs. TAU will be compared to see if there are any differences in social support, cognition, loneliness, psychosocial functioning, or healthy lifestyle activities including physical activity, sleep, and diet.
Participants will be asked to complete an interview-based assessment at baseline, 4-months, 8-months, and 12-months. After completing the baseline assessment, those who are in the experimental group will participate in the 16-week long HHL group intervention.
What is being tested
- Hopeful and Healthy Living (HHL) (behavioral)
Sponsor: Boston University Charles River Campus · Participants: 60 · Started: Mar 12, 2025
Contact the study team
- Alexa R Trolley-Hanson, MS OTR/L · Phone: 16037480379
- Susan McGurk, PhD · Phone: 617-353-3549
Official record on ClinicalTrials.gov — NCT06940843
Locations in the U.S.
| Massachusetts | Bay Cove Center Club, Boston Bay Cove Transitions of Boston, Boston |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.