Positive Minds Strong Bodies Implementation (PMSB-E)

Mass General Brigham

Status: Completed

Conditions: Physical Disability; Depression; Anxiety

Treatments: Behavioral: Enhanced Usual Care; Behavioral: Positive Minds Strong Bodies Enhanced

Study type: Interventional

Funder types: Other

Identifiers

NCT04545593

2019P001292

Details and patient eligibility

About

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.

Full 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.

Enrollment: 427 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

427 participants in 2 patient groups

Positive Minds Strong Bodies Enhanced

Experimental group

Description:

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.

Treatment:

Behavioral: Positive Minds Strong Bodies Enhanced

Enhanced Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care