Clinical Trials Directory

Trials / Completed

CompletedNCT02317432

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

Building Community Capacity for Disability Prevention for Minority Elders

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
307 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALComparison of a combined CBT + exercise intervention and enhanced usual care

Timeline

Start date
2015-07-01
Primary completion
2019-03-01
Completion
2019-03-01
First posted
2014-12-16
Last updated
2021-04-28
Results posted
2021-04-28

Locations

8 sites across 2 countries: United States, Puerto Rico

Source: ClinicalTrials.gov record NCT02317432. Inclusion in this directory is not an endorsement.