CompletedNot Applicable

Positive Minds Strong Bodies Implementation

United States427 participantsStarted 2021-02-11

Plain-language summary

This study aims to address treatment and service disparities and prevent disability among racial/ethnic and linguistic minority elders. It tests the effectiveness and implementation readiness of the Positive Minds-Strong Bodies Enhanced intervention (PMSB-E), a combined mental and physical health intervention designed to be implemented in low-resource community settings. This renewal grant project includes a streamlined intervention with new components designed to improve and maintain participant outcomes.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Latino, Asian, Black, or non-Latino White adults 60+ years of age * With mild, moderate or severe depressive or anxiety symptoms. * Participants receiving medications for mental health will have this recorded and used as a covariate. * Community-dwelling participants who have some mobility limitations but are not home-bound. Exclusion Criteria: * Any specialty mental health care (therapy sessions with psychiatrist, psychologist or social worker) in the past 3 months or scheduled in the coming month. * Evidence that patient lacks capacity to consent or is cognitively impaired * Current suicidal risk (score of 4 or 5 on Paykel suicide questionnaire), whereby participant will be connected to an emergency services or specialty provider per the study emergency protocol. * Physically instability, acute or exacerbation of a chronic disease, or a neuro-musculoskeletal impairment * Severe substance abuse * Self-reported psychosis or schizophrenia * Inability to commit to 2 sessions per week

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability

Timeframe: 12 months after baseline

Depression and Anxiety Symptoms as Assessed by Hopkins Symptom Checklist-25

Timeframe: 3, 6, and 12 months after baseline

Physical Functioning as Assessed by Short Physical Performance Battery

Timeframe: 3, 6, and 12 months after baseline

Physical Functioning as Assessed by the Function Component of the Late-Life Functioning and Disability Instrument

Timeframe: 3, 6, and 12 months after baseline

Trial details

NCT IDNCT04545593

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

Results submitted2026-03-10

View on ClinicalTrials.gov More Depression trials

Plain-language summary

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Acceptability

Timeframe: 12 months after baseline

Depression and Anxiety Symptoms as Assessed by Hopkins Symptom Checklist-25

Timeframe: 3, 6, and 12 months after baseline

Physical Functioning as Assessed by Short Physical Performance Battery

Timeframe: 3, 6, and 12 months after baseline

Physical Functioning as Assessed by the Function Component of the Late-Life Functioning and Disability Instrument

Timeframe: 3, 6, and 12 months after baseline