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

Boston University Charles River Campus

Status: Enrolling

Conditions: Older Adults; Serious Mental Illness

Treatments: Behavioral: Hopeful and Healthy Living (HHL)

Study type: Interventional

Funder types: Other

Identifiers

NCT06940843

90RTHF0007 (Other Grant/Funding Number)

7458B

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

HHL group participants

Experimental group

Description:

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.

Treatment:

Behavioral: Hopeful and Healthy Living (HHL)

Treatment as usual

No Intervention group

Description:

Participants assigned to this arm will continue with treatment as usual.