Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)

Mass General Brigham

Status: Completed

Conditions: Physical Disability; Depression; Anxiety

Treatments: Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT02317432

1R01AG046149-01A1

Details and patient eligibility

About

The primary intervention offered through this study is a manualized and culturally adapted CBT intervention combined with an exercise intervention, administered by trained Community Health Workers and exercise trainers to ethnic minority elders with moderate to severe mood symptoms and at risk of disability. In addition to the intervention implementation, the study examines how to successfully build collaborative research for the provision of evidence-based mental health and disability prevention treatments for ethnic minority elders in community-based settings. Thus, the study will evaluate the three components necessary for a successful intervention: efficacy, since the intervention must work, acceptability among clients and partnering agencies, and feasibility and sustainability within the organization.

Full description

The researchers have partnered with 5 community-based organizations and 2 clinics, each of whom will recruit 60 elder participants to be randomized into either the intervention (CBT+exercise) or control (enhanced usual care) groups. Each participant randomized into the intervention group will receive 10 sessions of individual CBT for depression and anxiety (Positive Minds), using a translated and culturally adapted manual, and administered by a trained community health worker. In addition, each participant will engage in three exercise groups per week for 12 weeks, using the Increased Velocity Specific to Task (Strong Bodies; InVEST) protocol. Both intervention and control groups will be assessed biweekly for symptoms of depression, anxiety, and suicidality, and both groups will participate in a thorough assessment at baseline, and 2, 6, and 12 months after baseline.

Enrollment: 307 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 60+
• Fluency in English, Spanish, Mandarin or Cantonese
• Score above threshold on PHQ-9, GAD-7, or Geriatric Depression Scale (GDS-Short Form)
• Score within threshold of SPPB

Exclusion criteria

• Participants will be excluded if there is evidence of:
• Current substance use disorders
• Current or last 3 months of specialty mental health treatment
• Evidence that patient the participant lacks capacity to consent assessed using the UCSD Brief Assessment of Capacity to Consent.
• Suicidal risk (score of 4 or 5 on the Paykel suicide questionnaire), whereby participant will be referred for immediate treatment to specialty care
• If the participant's physician advises against strenuous physical exercise.
• Exclusion from the disability component will also happen if the participant is home-bound, has an acute or an exacerbated chronic disease, or has neuro-musculoskeletal impairment that prevents them from participating in the exercises

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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307 participants in 2 patient groups

CBT + InVEST exercise

Experimental group

Description:

10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.

Treatment:

Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care

Enhanced Usual Care

Active Comparator group

Description:

Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.

Treatment:

Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care