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

NCT06940843 | Recruiting

• 2 other identifiers: 7458B90RTHF0007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

psychosocial interventions; cognitive interventions; social skills interventions; healthy lifestyle interventions; older adults with SMI

Outcome Measures

Primary Outcomes (8)

• Montreal Cognitive Assessment (MOCA)

  Standardized screening tool used for assessing cognition.

  Baseline, 4-, 8-, 12- month followup

• The Cognitive Self-Efficacy Scale

  10-item measure that assesses confidence in everyday cognitive tasks.

  Baseline, 4-, 8-, 12- month followup

• The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure

  Adult will be used to assess and statistically control for mental health symptom severity.

  Baseline, 4-, 8-, 12- month followup

• The UCLA Loneliness Scale-3-item instrument

  3-item screening tool for loneliness.

  Baseline, 4-, 8-, 12- month followup

• The Social Provisions Scale

  24-item instrument that will be used to measure various types of social supports.

  Baseline, 4-, 8-, 12- month followup

• The Physical Activity Scale for the Elderly (PASE)

  Standardized measurement of physical activity related to exercise, work, recreation, and daily living activities.

  Baseline, 4-, 8-, 12- month followup

• Starting the Conversation

  A brief standardized survey for assessing daily eating habits.

  Baseline, 4-, 8-, 12- month followup

• Pittsburg Sleep Quality Index (PSQI)

  An 11-item tool that is used to assess sleep quality and routines.

  Baseline, 4-, 8-, 12- month followup

Secondary Outcomes (1)

• HHL Group Satisfaction and Feedback Survey

  4-month assessment only

Study Arms (2)

HHL group participants

EXPERIMENTAL

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.

Behavioral: Hopeful and Healthy Living (HHL)

Treatment as usual

NO INTERVENTION

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

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.

HHL group participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older, diagnosis of a serious mental illness, and a member of Center Club or Transitions of Boston

You may not qualify if:

• Diagnosis of dementia or other progressive neurological disorder

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Bay Cove Human Services: collaborator

Study Sites (2)

Bay Cove Center Club

Boston, Massachusetts, 02114, United States

RECRUITING

Bay Cove Transitions of Boston

Boston, Massachusetts, 02122, United States

RECRUITING

Study Officials

• Susan McGurk, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Kim Mueser, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexa R Trolley-Hanson, MS OTR/L

CONTACT

16037480379; athanson@bu.edu

Susan McGurk, PhD

CONTACT

617-353-3549; mcgurk@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)