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

Not Applicable

Recruiting

• Conditions: Serious Mental Illness; Older Adults

• Registration Number: NCT06940843
• Lead Sponsor: Boston University Charles River Campus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-12
• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-22
• Study First Posted: 2025-04-23
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2028-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure	Baseline, 4-, 8-, 12- month followup	Adult will be used to assess and statistically control for mental health symptom severity.
The UCLA Loneliness Scale-3-item instrument	Baseline, 4-, 8-, 12- month followup	3-item screening tool for loneliness.
The Social Provisions Scale	Baseline, 4-, 8-, 12- month followup	24-item instrument that will be used to measure various types of social supports.
The Physical Activity Scale for the Elderly (PASE)	Baseline, 4-, 8-, 12- month followup	Standardized measurement of physical activity related to exercise, work, recreation, and daily living activities.
Starting the Conversation	Baseline, 4-, 8-, 12- month followup	A brief standardized survey for assessing daily eating habits.
Pittsburg Sleep Quality Index (PSQI)	Baseline, 4-, 8-, 12- month followup	An 11-item tool that is used to assess sleep quality and routines.
Montreal Cognitive Assessment (MOCA)	Baseline, 4-, 8-, 12- month followup	Standardized screening tool used for assessing cognition.
The Cognitive Self-Efficacy Scale	Baseline, 4-, 8-, 12- month followup	10-item measure that assesses confidence in everyday cognitive tasks.

Secondary Outcome Measures

Name	Time	Method
HHL Group Satisfaction and Feedback Survey	4-month assessment only	For experimental group participants only.

Trial Locations

Locations (2)

Bay Cove Center Club; 🇺🇸 Boston, Massachusetts, United States

Bay Cove Transitions of Boston; 🇺🇸 Boston, Massachusetts, United States