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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University Charles River Campus
Study ID
NCT06940843
Status
Recruiting
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Conditions

  • Older Adults
  • Serious Mental Illness

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hopeful and Healthy Living (HHL) — BEHAVIORAL
    The HHL intervention is a 16-week long, manualized group intervention. Classes will be held weekly for 90 minutes. The class covers 15 topics centered on building social connections, developing healthy lifestyle routines around eating, exercise, and sleep. Each class will target one social skill (i.e. starting conversations) and one cognitive self-management strategy (i.e. memory tips), which will be taught and practiced in class. Each class also includes a facilitated exercise component and individually tailored take home application activity.

Study Details

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 Dates

Start date
Mar 12, 2025
Status verified
Apr 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HHL group participants
    Participants will complete the 16-week manualized HHL intervention. This group intervention will occur weekly for 90 minutes. These participants will also continue with treatment as usual.
  • No Intervention: Treatment as usual
    Participants assigned to this arm will continue with treatment as usual.

Primary Outcome Measure

Montreal Cognitive Assessment (MOCA) [ Time Frame: Baseline, 4-, 8-, 12- month followup ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Bay Cove Center ClubBostonMassachusetts02114
Program Director
[email protected]
617-788-1000
[email protected]
Susan McGurk, PhD (PRINCIPAL_INVESTIGATOR)
Alexa Trolley-Hanson, MS (SUB_INVESTIGATOR)
Bay Cove Transitions of BostonBostonMassachusetts02122
Program Director
[email protected]
(617) 788-1024
[email protected]
Susan McGurk, PhD (PRINCIPAL_INVESTIGATOR)
Alexa Trolley-Hanson, MS (SUB_INVESTIGATOR)

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