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Trials / Completed

CompletedNCT04545593

Positive Minds Strong Bodies Implementation

Building Community Capacity for Disability Prevention for Minority Elders - Renewal

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
427 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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.

Detailed description

The Positive Minds-Strong Bodies Enhanced intervention addresses the dual challenges of mental health and physical disability among minority elders. The core Positive Minds intervention includes 10 sessions offered by Community Health Workers over a maximum of 6 months, designed to identify and correct negative distortions or cognitions, promote behavioral activation and encourage supportive relationships. Strong Bodies is a 36-session physical intervention consisting of a series of exercises conducted while wearing a weighted vest in a group setting over 6 months; both interventions include a group maintenance component to maintain gains. The investigators will evaluate the acceptability, effectiveness and twelve-month sustainability of the Enhanced Positive Minds-Strong Bodies intervention (E-PMSB) offered by Community Health Workers (CHWs) and Exercise Trainers in community-based organizations (CBOs) and community clinics. The intervention is offered in English, Spanish, Mandarin or Cantonese.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPositive Minds Strong Bodies EnhancedThe Positive Minds Strong Bodies Enhanced intervention (PMSB-E) was designed to provide a single, integrated program that could address the dual challenges of mental health and disability among minority elders. PMSB-E seeks to improve mood symptoms, identify and correct negative distortions or cognitions, promote behavioral activation through engaging the participant in pleasant activities, and encourage developing supportive relationships. All sessions are tailored to the participant's needs using a collaborative approach.
BEHAVIORALEnhanced Usual CareParticipants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. Research staff will call the participant 4 times over the course of 6 months to administer mental health items, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group.

Timeline

Start date
2021-02-11
Primary completion
2024-10-31
Completion
2024-10-31
First posted
2020-09-11
Last updated
2026-03-30
Results posted
2026-03-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04545593. Inclusion in this directory is not an endorsement.