Viewing Study NCT04545593



Ignite Creation Date: 2024-05-06 @ 3:11 PM
Last Modification Date: 2024-10-26 @ 1:44 PM
Study NCT ID: NCT04545593
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-05-06
First Post: 2020-09-04

Brief Title: Positive Minds Strong Bodies Implementation
Sponsor: Massachusetts General Hospital
Organization: Massachusetts General Hospital

Study Overview

Official Title: Building Community Capacity for Disability Prevention for Minority Elders - Renewal
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PMSB-E
Brief Summary: This study aims to address treatment and service disparities and prevent disability among racialethnic 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None