Positive Minds Strong Bodies Implementation

Not Applicable

Completed

• Conditions: Anxiety; Depression; Physical Disability
• Interventions: Behavioral: Positive Minds Strong Bodies Enhanced; Behavioral: Enhanced Usual Care

• Registration Number: NCT04545593
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-11
• Study Start: 2021-02-11
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 427

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive Minds Strong Bodies Enhanced	Positive Minds Strong Bodies Enhanced	The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) consists of 10 sessions focused on mental health (PM) and 36 sessions focused on physical health (SB), along with a group maintenance component.
Enhanced Usual Care	Enhanced Usual Care	The Enhanced Usual Care condition includes written materials on depression and anxiety and 4 calls to participants over the course of 6 months to assess symptoms and safety.

Primary Outcome Measures

Name	Time	Method
Hopkins Symptom Checklist-25 (change)	Baseline and 3, 6, and 12 months after baseline	Widely used measure of depression and anxiety in clinical monitoring and outcome assessment.
Acceptability	6 months at end of treatment	\>/= 70% of participants attending \>/= 50% of their intervention sessions, reporting satisfaction with treatment.
Late-Life Function and Disability Instrument (LLFDI) - functional component (change)	Baseline and 3, 6, and 12 months after baseline	Self-report instrument designed to measure both functional capacity and components of disability.
Short Physical Performance Battery (change)	Baseline and 3, 6, and 12 months after baseline	Assessment of standing balance, timed 4-m walk, and timed test of five chair-rise repetitions, to assess functional limitations. A virtual option will be used while in person assessment is not possible due to COVID-19.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States