N/A
N=307
Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)
Depression · Anxiety · Physical Disability
Bottom Line
View on ClinicalTrials.gov: NCT02317432 ↗Enrolled (actual)
307
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions — 118; 63; 58; 121 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Comparison of a combined CBT + exercise intervention and enhanced usual care (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions |
118; 63; 58; 121 | — |
| PRIMARY Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up |
1.44; 1.56 | <0.01 sig |
| PRIMARY Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up |
7.89; 7.29 | 0.03 sig |
| PRIMARY Change in Self-reported Level of Functioning in the Function Component of the Late Life Functioning and Disability Instrument (LLFDI) From Baseline, at 6-month Follow-up. |
120.87; 114.87 | 0.02 sig |
| PRIMARY Change in Level of Functioning in the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) From Baseline, at 6-month Follow-up. |
21.23; 22.47 | 0.15 |
| PRIMARY Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up |
4.80; 5.29 | 0.35 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02317432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.