Positive Minds Strong Bodies Implementation

NCT04545593 | Completed Results DMC

• 1 other identifier: 2019P001292
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Physical Disability

Keywords

Minority Elders

Outcome Measures

Primary Outcomes (4)

• Acceptability

  \>/= 70% of participants attending \>/= 50% of their intervention sessions, reporting satisfaction with treatment. This outcome was measured among intervention participants only (Positive Minds Strong Bodies Enhanced) using four indicator variables for attending 5+ (out of 10) PM intervention sessions, 18+ (out of 36) SB intervention sessions, being very satisfied with the care received by intervention provider, and being very satisfied with the program.

  12 months after baseline

• Depression and Anxiety Symptoms as Assessed by Hopkins Symptom Checklist-25

  The Hopkins Symptom Checklist-25 (HSCL-25) assessed past 2-week self-reported symptoms of depression and anxiety. The HSCL-25 includes 25 items, each rated from 1 (not at all) to 4 (extremely). Total raw scores are calculated by averaging all items (range 1 to 4, with higher scores indicating more severe symptoms). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of HSCL-25 scores across follow-up assessments, adjusting for baseline HSCL-25 scores.

  3, 6, and 12 months after baseline

• Physical Functioning as Assessed by Short Physical Performance Battery

  The Short Physical Performance Battery (SPPB) objectively assessed physical functioning through balance, gait, and chair-rise timed tests. A summary performance score is calculated by summing categorical rankings on the three tests (range 0 to 12, with higher scores indicating better performance). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of SPPB scores across follow-up assessments, adjusting for baseline SPPB scores.

  3, 6, and 12 months after baseline

• Physical Functioning as Assessed by the Function Component of the Late-Life Functioning and Disability Instrument

  The Function Component of the Late-Life Functioning and Disability Instrument (LLFDI) assessed self-reported physical functioning, with 32 items assessing difficulty (1 'cannot do' to 5 'none') to perform discrete actions or activities without the help of someone else or using assistive devices. Total scores are calculated by summing all items (range 32 to 160, with higher scores indicating fewer difficulties). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of LLFDI scores across follow-up assessments, adjusting for baseline LLFDI scores.

  3, 6, and 12 months after baseline

Secondary Outcomes (1)

• Disability as Assessed by World Health Organization Disability Assessment Schedule 2.0

  3, 6, and 12 months after baseline

Study Arms (2)

Positive Minds Strong Bodies Enhanced

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

Enhanced Usual Care BEHAVIORAL

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.

Enhanced Usual Care

Positive Minds Strong Bodies Enhanced BEHAVIORAL

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.

Positive Minds Strong Bodies Enhanced

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Limitations and Caveats

The study was concluded as planned and no technical problems with measurement were experienced.

Results Point of Contact

• Title: Dr. Margarita Alegria
• Organization: Massachusetts General Hospital

malegria@mgh.harvard.edu

617-724-1237

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff conducting follow up assessments will be blinded to participant condition in the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Disparities Research Unit

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 11, 2020
• Study Start: February 11, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: April 21, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)