Positive Minds Strong Bodies Implementation (PMSB-E)

Building Community Capacity for Disability Prevention for Minority Elders - Renewal

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety; Physical Disability
• Intervention / Treatment: Behavioral: Positive Minds Strong Bodies Enhanced; Behavioral: Enhanced Usual Care

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 Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margarita Alegria, Ph.D.; Phone Number: (617) 724-4987; Email: malegria@mgh.harvard.edu
• Study Contact Backup: Name: Sheri Markle, MIA; Phone Number: 617-643-5042; Email: smarkle@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Margarita Alegria, PhD; Phone Number: 617-724-4987; Email: malegria@mgh.harvard.edu
      • Contact: Sheri L Markle, MIA; Phone Number: 617-643-5042; Email: smarkle@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Positive Minds Strong Bodies Enhanced; The 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.
Active Comparator: 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.	Behavioral: Enhanced Usual Care; Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	>/= 70% of participants attending >/= 50% of their intervention sessions, reporting satisfaction with treatment.	6 months at end of treatment
Hopkins Symptom Checklist-25 (change)	Widely used measure of depression and anxiety in clinical monitoring and outcome assessment.	Baseline and 3, 6, and 12 months after baseline
Short Physical Performance Battery (change)	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.	Baseline and 3, 6, and 12 months after baseline
Late-Life Function and Disability Instrument (LLFDI) - functional component (change)	Self-report instrument designed to measure both functional capacity and components of disability.	Baseline and 3, 6, and 12 months after baseline

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 11, 2020

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Minority Elders
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2019P001292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No