Positive Minds Strong Bodies Implementation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Building Community Capacity for Disability Prevention for Minority Elders - Renewal

Conditions
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Depression, Anxiety, Physical Disability

Intervention / Treatment
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* Behavioral: Positive Minds Strong Bodies Enhanced
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Minds Strong Bodies Enhanced<br>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<br>* 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.<br>|
| Active Comparator: Enhanced Usual Care<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minority Elders