Recruiting

Hopeful & Healthy

Sponsor:

Boston University Charles River Campus

Code:

NCT06940843

Conditions

Serious Mental Illness

Older Adults

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Hopeful and Healthy Living (HHL)

Study Details

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 ID

NCT06940843

Start date

Mar 12, 2025

Status verified date

Jul, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Primary outcome measure

  • Montreal Cognitive Assessment (MOCA) [ Time Frame: Baseline, 4-, 8-, 12- month followup ]
  • The Cognitive Self-Efficacy Scale [ Time Frame: Baseline, 4-, 8-, 12- month followup ]
  • The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure [ Time Frame: Baseline, 4-, 8-, 12- month followup ]
  • The UCLA Loneliness Scale-3-item instrument [ Time Frame: Baseline, 4-, 8-, 12- month followup ]
  • The Social Provisions Scale [ Time Frame: Baseline, 4-, 8-, 12- month followup ]
  • The Physical Activity Scale for the Elderly (PASE) [ Time Frame: Baseline, 4-, 8-, 12- month followup ]
  • Starting the Conversation [ Time Frame: Baseline, 4-, 8-, 12- month followup ]
  • Pittsburg Sleep Quality Index (PSQI) [ Time Frame: Baseline, 4-, 8-, 12- month followup ]

Central Contacts and Locations

Central contacts

Alexa R Trolley-Hanson, MS OTR/L

16037480379athanson@bu.edu

Susan McGurk, PhD

617-353-3549mcgurk@bu.edu

Locations

Bay Cove Center Club

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Program Director

617-788-1000mgregorio@baycove.org

athanson@bu.edu

Principal Investigator:

Susan McGurk, PhD

Bay Cove Transitions of Boston

Recruiting

Boston, Massachusetts, United States, 02122

Contacts

Program Director

617-788-1024jdorneus@baycove.org

athanson@bu.edu

Principal Investigator:

Susan McGurk, PhD

More Information

Sponsor

Boston University Charles River Campus

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University Charles River Campus on 2026-07-20.