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

NCT ID: NCT02317432

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2019-03-01

Brief Summary

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.

Detailed 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.

Conditions

Depression; Anxiety; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CBT + InVEST exercise

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Enhanced Usual Care

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York University

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Margarita Alegria, PhD

Chief, Disparities Research Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margarita Alegria, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

King David Foundation

Aventura, Florida, United States

Greater Boston Chinese Golden Age Center

Boston, Massachusetts, United States

MGH Chelsea

Chelsea, Massachusetts, United States

Kit Clark Senior Services

Dorchester, Massachusetts, United States

MGH Revere

Revere, Massachusetts, United States

Central Harlem Senior Citizens' Center

New York, New York, United States

Hamilton Madison City Hall Senior Center

New York, New York, United States

University of Puerto Rico

San Juan, PR, Puerto Rico

Countries

United States; Puerto Rico

References

Zhang L, Cruz-Gonzalez M, Lin Z, Ouyang X, Zhao F, Alegria M. Association of everyday discrimination with health outcomes among Asian and non-Asian US older adults before and during the COVID-19 pandemic. Front Public Health. 2022 Oct 19;10:953155. doi: 10.3389/fpubh.2022.953155. eCollection 2022.

Reference Type: DERIVED

PMID: 36339195 (View on PubMed)

Porteny T, Alegria M, Del Cueto P, Fuentes L, Markle SL, NeMoyer A, Perez GK. Barriers and strategies for implementing community-based interventions with minority elders: positive minds-strong bodies. Implement Sci Commun. 2020 Apr 30;1:41. doi: 10.1186/s43058-020-00034-4. eCollection 2020.

Reference Type: DERIVED

PMID: 32885198 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01AG046149-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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