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Can a 16-Week group program help older adults with mental illness build stronger social ties and healthier routines?

NCT ID NCT06940843

Disease control Sponsor: Boston University Charles River Campus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This trial tests a 16-week group program called Hopeful and Healthy Living (HHL) for adults over 50 with serious mental illness. The program combines social skills training, cognitive strategies, exercise, and healthy lifestyle education. Participants are randomly assigned to either the HHL program or their usual care, and researchers track changes in social support, loneliness, cognition, physical activity, sleep, and diet over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a 16-week group program combining social skills training, cognitive self-management strategies, exercise, and healthy lifestyle education
What this could lead to
If effective, this program could offer a practical, non-drug way to improve social support, cognition, and healthy behaviors in older adults with serious mental illness.
What could go wrong
This is a small pilot study (60 participants) with no blinding, so results may not generalize. The program is time-intensive and may not suit everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Older adults Serious mental illness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bay Cove Center Club

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Bay Cove Transitions of Boston

    RECRUITING

    Boston, Massachusetts, 02122, United States

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