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NCT Number: NCT06940843

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bay Cove Center Club, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hopeful and Healthy Living (HHL)

Behavioral

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.

Primary outcomes

  1. Montreal Cognitive Assessment (MOCA)

    Time frame: Baseline, 4-, 8-, 12- month followup

    Standardized screening tool used for assessing cognition.

  2. The Cognitive Self-Efficacy Scale

    Time frame: Baseline, 4-, 8-, 12- month followup

    10-item measure that assesses confidence in everyday cognitive tasks.

  3. The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure

    Time frame: Baseline, 4-, 8-, 12- month followup

    Adult will be used to assess and statistically control for mental health symptom severity.

  4. The UCLA Loneliness Scale-3-item instrument

    Time frame: Baseline, 4-, 8-, 12- month followup

    3-item screening tool for loneliness.

  5. The Social Provisions Scale

    Time frame: Baseline, 4-, 8-, 12- month followup

    24-item instrument that will be used to measure various types of social supports.

  6. The Physical Activity Scale for the Elderly (PASE)

    Time frame: Baseline, 4-, 8-, 12- month followup

    Standardized measurement of physical activity related to exercise, work, recreation, and daily living activities.

  7. Starting the Conversation

    Time frame: Baseline, 4-, 8-, 12- month followup

    A brief standardized survey for assessing daily eating habits.

  8. Pittsburg Sleep Quality Index (PSQI)

    Time frame: Baseline, 4-, 8-, 12- month followup

    An 11-item tool that is used to assess sleep quality and routines.

Secondary outcomes

  1. HHL Group Satisfaction and Feedback Survey

    Time frame: 4-month assessment only

    For experimental group participants only.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexa R Trolley-Hanson, MS OTR/L

CONTACT

[email protected]

16037480379

Susan McGurk, PhD

CONTACT

[email protected]

617-353-3549

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • Bay Cove Human Services

Registry information

Official study title

Enhancing Social Connection, Health, and Aging in Older Persons: A Pilot Randomized Trial of the Hopeful and Healthy Living (HHL) Program

Acronym: (HHL)

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 23, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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