N/A
N=427
Positive Minds Strong Bodies Implementation
Depression · Anxiety · Physical Disability
Bottom Line
View on ClinicalTrials.gov: NCT04545593 ↗Enrolled (actual)
427
Serious AEs
0.5%
Results posted
Mar 2026
Primary outcome: Primary: Acceptability — 167; 132; 80; 82 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Minds Strong Bodies Enhanced (Behavioral); Enhanced Usual Care (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability |
167; 132; 80; 82 | — |
| PRIMARY Depression and Anxiety Symptoms as Assessed by Hopkins Symptom Checklist-25 |
1.45; 1.52; 1.49; 1.50; 1.51; 1.50 | — |
| PRIMARY Physical Functioning as Assessed by Short Physical Performance Battery |
8.78; 8.03; 8.81; 8.08; 8.80; 8.19 | — |
| PRIMARY Physical Functioning as Assessed by the Function Component of the Late-Life Functioning and Disability Instrument |
118.39; 113.39; 114.52; 113.03; 114.83; 112.13 | — |
| SECONDARY Disability as Assessed by World Health Organization Disability Assessment Schedule 2.0 |
21.04; 22.54; 21.88; 23.01; 22.69; 22.86 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04545593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.