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

NCT ID: NCT06940843

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2028-07-31

Brief Summary

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.

Conditions

Serious Mental Illness; Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hopeful and Healthy Living (HHL)

Intervention Type: 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.

Treatment as usual

Participants assigned to this arm will continue with treatment as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hopeful and Healthy Living (HHL)

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bay Cove Human Services

OTHER

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan McGurk, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Kim Mueser, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Bay Cove Center Club

Boston, Massachusetts, United States

Site Status: RECRUITING

Bay Cove Transitions of Boston

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexa R Trolley-Hanson, MS OTR/L

Role: CONTACT

athanson@bu.edu

16037480379

Susan McGurk, PhD

Role: CONTACT

mcgurk@bu.edu

617-353-3549

Facility Contacts

Program Director

Role: primary

mgregorio@baycove.org

617-788-1000

Role: backup

athanson@bu.edu

Program Director

Role: primary

jdorneus@baycove.org

(617) 788-1024

Role: backup

athanson@bu.edu

Other Identifiers

90RTHF0007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

7458B

Identifier Type: -

Identifier Source: org_study_id