NCT06940843 A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program
| NCT ID | NCT06940843 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University Charles River Campus |
| Condition | Serious Mental Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-12 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-03-12 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Susan McGurk, PhD
PRINCIPAL INVESTIGATOR
Boston University
Frequently Asked Questions
Who can join the NCT06940843 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Serious Mental Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06940843 currently recruiting?
Yes, NCT06940843 is actively recruiting participants. Contact the research team at athanson@bu.edu for enrollment information.
Where is the NCT06940843 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT06940843 clinical trial?
NCT06940843 is sponsored by Boston University Charles River Campus. The principal investigator is Susan McGurk, PhD at Boston University. The trial plans to enroll 60 participants.