Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06940843

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

Led by Boston University Charles River Campus · Updated on 2025-04-25

60

Participants Needed

2

Research Sites

176 weeks

Total Duration

On this page

Sponsors

B

Boston University Charles River Campus

Lead Sponsor

B

Bay Cove Human Services

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 50 years or older
  • Diagnosis of a serious mental illness
  • Member of Center Club or Transitions of Boston
Not Eligible

You will not qualify if you...

  • Diagnosis of dementia
  • Diagnosis of other progressive neurological disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Bay Cove Center Club

Boston, Massachusetts, United States, 02114

Actively Recruiting

2

Bay Cove Transitions of Boston

Boston, Massachusetts, United States, 02122

Actively Recruiting

Loading map...

Research Team

A

Alexa R Trolley-Hanson, MS OTR/L

CONTACT

S

Susan McGurk, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here