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

Purpose

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

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Boston University Charles River Campus

Study Contact

Alexa R Trolley-Hanson, MS OTR/L
16037480379
athanson@bu.edu