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NCT06940843 · ClinicalTrials.gov registry record · NA
A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program
A NA study of Older Adults and Serious Mental Illness, sponsored by Boston University Charles River Campus.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT06940843: Recruiting NA study of Older Adults and Serious Mental Illness, sponsored by Boston University Charles River Campus.
NCT06940843 is a NA study of Older Adults and Serious Mental Illness that is actively recruiting participants, run by Boston University Charles River Campus. The registered enrollment target is 60 participants, below the 223-participant average among 23 other Older Adults trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06940843, a NA study of Older Adults and Serious Mental Illness, is actively recruiting participants, sponsored by Boston University Charles River Campus.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Standardized screening tool used for assessing cognition.
Conditions Studied
Interventions
- BEHAVIORAL Hopeful and Healthy Living (HHL)
Study Locations (2)
Massachusetts
- Bay Cove Center Club - Boston
- Bay Cove Transitions of Boston - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-03-12 |
| Est. Completion | 2028-07-31 |
| Phase | NA |
What NCT06940843 shows while recruiting
NCT06940843 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 223-participant average among 23 other Older Adults trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Older Adults appearing as the primary indexed condition, and to 1 intervention - of which Hopeful and Healthy Living (HHL) is the first listed.
NCT06940843 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06940843 about?
NCT06940843 is a clinical study titled "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...
What is the current status of trial NCT06940843?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-03-12. Estimated completion is 2028-07-31.
What conditions does trial NCT06940843 study?
This clinical trial studies the following conditions: Older Adults, Serious Mental Illness.
What interventions are being tested in trial NCT06940843?
The interventions under investigation include: Hopeful and Healthy Living (HHL) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06940843?
This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06940843 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06940843's enrollment target sits among peer trials
60 13th of 23 higher than 11 of 23 other Older Adults trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Older Adults trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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