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

Depression Clinical Trial

Official title:

Building Community Capacity for Disability Prevention for Minority Elders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317432
• Other study ID #: 1R01AG046149-01A1
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Physical Disability

Intervention

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

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan
United States	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	Central Harlem Senior Citizens' Center	New York	New York
United States	Hamilton Madison City Hall Senior Center	New York	New York
United States	MGH Revere	Revere	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	New York University, Vanderbilt University

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
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.	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
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.	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
Primary	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