Clinical trial NCT06940843: A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program
Official title: Enhancing Social Connection, Health, and Aging in Older Persons: A Pilot Randomized Trial of the Hopeful and Healthy Living (HHL) Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Serious Mental Illness
Older Adults
Keywords: psychosocial interventions
cognitive interventions
social skills interventions
healthy lifestyle interventions
older adults with SMI
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Bay Cove Human Services
First posted: 2025-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline, 4-, 8-, 12- month followup
measure: The Cognitive Self-Efficacy Scale
timeFrame: Baseline, 4-, 8-, 12- month followup
measure: The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure
timeFrame: Baseline, 4-, 8-, 12- month followup
measure: The UCLA Loneliness Scale-3-item instrument
timeFrame: Baseline, 4-, 8-, 12- month followup
measure: The Social Provisions Scale
timeFrame: Baseline, 4-, 8-, 12- month followup
measure: The Physical Activity Scale for the Elderly (PASE)
timeFrame: Baseline, 4-, 8-, 12- month followup
measure: Starting the Conversation
timeFrame: Baseline, 4-, 8-, 12- month followup
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: Baseline, 4-, 8-, 12- month followup
Secondary outcomes:
measure: HHL Group Satisfaction and Feedback Survey
timeFrame: 4-month assessment only
Other outcomes:
Locations:
city: Boston
country: United States
facility: Bay Cove Center Club
state: Massachusetts
city: Boston
country: United States
facility: Bay Cove Transitions of Boston
state: Massachusetts
Study officials:
affiliation: Boston University
name: Susan McGurk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Kim Mueser, PhD
role: PRINCIPAL_INVESTIGATOR
References: