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

Enhancing Social Connection, Health, and Aging in Older Persons: A Pilot Randomized Trial of the Hopeful and Healthy Living (HHL) Program

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.

Study Overview

• Status: Recruiting
• Conditions: Older Adults; Serious Mental Illness
• Intervention / Treatment: Behavioral: Hopeful and Healthy Living (HHL)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan McGurk, PhD; Phone Number: 617-353-3549; Email: mcgurk@bu.edu
• Study Contact Backup: Name: Alexa R Trolley-Hanson, MS OTR/L; Phone Number: 16037480379; Email: athanson@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Bay Cove Center Club
      • Contact: Program Director; Phone Number: 617-788-1000; Email: mgregorio@baycove.org
      • Contact: Email: athanson@bu.edu
      • Contact: Susan McGurk, PhD
      • Contact: Alexa Trolley-Hanson, MS
    • Boston, Massachusetts, United States, 02122
      • Recruiting
      • Bay Cove Transitions of Boston
      • Contact: Email: athanson@bu.edu
      • Contact: Susan McGurk, PhD
      • Contact: Alexa Trolley-Hanson, MS
      • Contact: Program Director; Phone Number: (617) 788-1024; Email: jdorneus@baycove.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
No Intervention: Treatment as usual; Participants assigned to this arm will continue with treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HHL Group Satisfaction and Feedback Survey	For experimental group participants only.	4-month assessment only

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: Bay Cove Human Services
• Investigators: Principal Investigator: Susan McGurk, PhD, Boston University; Principal Investigator: Kim Mueser, PhD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: psychosocial interventions; cognitive interventions; social skills interventions; healthy lifestyle interventions; older adults with SMI
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 7458B; 90RTHF0007 (Other Grant/Funding Number: Nat. Ins. on Disability, Indepen. Living and Rehab Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No