A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program

Recruiting now · Not applicable

Conditions studied: Serious Mental Illness, Older Adults

In brief

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.

Key facts

Study ID
NCT06940843
Run by
Boston University Charles River Campus
People needed
60
Starts
2025-03-12
Expected to finish
2028-07-31
Last updated by the study team
2026-07-20

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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