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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Building Community Capacity for Disability Prevention for Minority Elders

Conditions
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Depression, Anxiety, Physical Disability

Intervention / Treatment
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* Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT + InVEST exercise<br>10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period. | Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care<br> <br> |
| Active Comparator: Enhanced Usual Care<br>Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders. | Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions | The number of participants attending more than 50% of intervention sessions was measured in three ways: (1) number attending 50% or more of the CBT sessions (CBT), (2) number attending 50% or more of the InVEST exercise sessions (InVEST), and (3) number attending 50% or more of the CBT and InVEST sessions (CBT and InVEST). Satisfaction with the intervention sessions was measured as the number of participants reporting to be very satisfied. | 6-months post-baseline | 
| Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up | The HSCL-25 is a 25-item screener of mood symptoms (ten anxiety symptoms and 15 depressive symptoms). Respondents are asked how much they were bothered by each symptom in the last four weeks, with responses rated on a 4-point scale (1 = not at all and 4 = extremely). Total scores are computed averaging all items (range: 1-4), and higher scores represent worse symptoms. | 6-months post-baseline | 
| Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up | The SPPB is an objective assessment tool developed by the National Institute of Aging to evaluate lower extremity functioning in older persons. It includes three tests (subscales) of functional relevance: standing balance, 4-meter gait speed, and five-repetition sit-to-stand motion. Each of the three components is scored on a 5-point subscale from 0 (unable to perform or low performance) to 4 (high performance). These three subscales are added to obtain a summary score than ranges between 0 and 12, with higher scores representing higher performance of physical functioning. | 6-months post-baseline | 
| 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. | The Function Component of the LLFDI is a 32-item self-reported measure assessing difficulty in performing discrete daily physical activities in older adults. Respondents are asked about difficulties performing an activity without help from someone else or the use of assisted devices, with responses rated on a 5-point scale (1 = cannot do and 5 = none). Total scores are calculated summing all items (range: 32-160), and lower scores (approaching 32) are worse as they indicate more difficulties performing discrete daily activities, while higher scores are better as they indicate less difficulties. | 6-months post-baseline | 
| 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. | The WHODAS 2.0 is a 12-item measure of level of functioning in six domains of life: Cognition, mobility, self-care, getting along, life activities, and participation. Respondents are asked about functioning difficulties experienced in the last 30 days, with responses rated on a 5-point scale (1 = none and 5 = extreme or cannot do). Final scores are calculated summing all items (range: 12-60), and higher scores represent more difficulties. | 6-months post-baseline | 
| Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up | The GAD-7 is a 7-item self-reported tool to identify probable cases of Generalized Anxiety Disorder. Respondents are asked how often, during the last two weeks, they were bothered by each symptom, with responses rated on a 4-point scale (0 = not at all and 3 = nearly every day). Total scores are calculated summing all items (range: 0-21), and higher scores represent worse symptoms. | 6-moths post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elders, Anxiety, Ethnic Minority, Depression, Disability