A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hopeful and Healthy Living (HHL).
- Who it may be relevant to
- Registry conditions: Serious Mental Illness, Older Adults. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Enhancing Social Connection, Health, and Aging in Older Persons: A Pilot Randomized Trial of the Hopeful and Healthy Living (HHL) Program
Overview
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.
Interventions
- 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 ind
Primary outcome measures
- 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]
Secondary outcome measures (1)
- HHL Group Satisfaction and Feedback Survey [Time frame: 4-month assessment only]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Bay Cove Center Club — Boston
- Bay Cove Transitions of Boston — Boston
Identifiers
NCT: NCT06940843 · 7458B · 90RTHF0007