Skip to main content
OpenTrials
Completed

NCT Number: NCT04545593

Positive Minds Strong Bodies Implementation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Acceptability

    Time frame: 12 months after baseline

    >/= 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.

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

    Time frame: 3, 6, and 12 months after baseline

    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. Physical Functioning as Assessed by Short Physical Performance Battery

    Time frame: 3, 6, and 12 months after baseline

    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.

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

    Time frame: 3, 6, and 12 months after baseline

    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.

Secondary outcomes

  1. Disability as Assessed by World Health Organization Disability Assessment Schedule 2.0

    Time frame: 3, 6, and 12 months after baseline

    The 12-item version of the WHO Disability Assessment Schedule (WHODAS 2.0) assessed past 30-day self-reported disability to capture difficulty performing activities in six domains of life (1 'none' to 5 'extreme or cannot do'). Total scores are calculated by summing all items (range 12 to 60, with higher scores indicating greater disability). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of WHODAS 2.0 scores across follow-up assessments, adjusting for baseline WHODAS 2.0 scores.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Building Community Capacity for Disability Prevention for Minority Elders - Renewal

Acronym: PMSB-E

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 11, 2020
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.