Clinical trial NCT04545593: Positive Minds Strong Bodies Implementation
Official title: Building Community Capacity for Disability Prevention for Minority Elders - Renewal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Physical Disability
Keywords: Minority Elders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 427
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: 6 months at end of treatment
measure: Hopkins Symptom Checklist-25 (change)
timeFrame: Baseline and 3, 6, and 12 months after baseline
measure: Short Physical Performance Battery (change)
timeFrame: Baseline and 3, 6, and 12 months after baseline
measure: Late-Life Function and Disability Instrument (LLFDI) - functional component (change)
timeFrame: Baseline and 3, 6, and 12 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: