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

NCT02317432 | Completed Results

• 1 other identifier: 1R01AG046149-01A1
• Study Type: interventional
• Target: 307
• Locations: 2 countries
• Sites: 8

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.

Conditions

Depression; Anxiety; Physical Disability

Keywords

Depression; Anxiety; Disability; Ethnic Minority; Elders

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

CBT + InVEST exercise

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

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

CBT + InVEST exercise; Enhanced Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• New York University: collaborator
• Vanderbilt University: collaborator

Study Sites (8)

King David Foundation

Aventura, Florida, 33180, United States

Location

Greater Boston Chinese Golden Age Center

Boston, Massachusetts, 02111, United States

Location

MGH Chelsea

Chelsea, Massachusetts, United States

Location

Kit Clark Senior Services

Dorchester, Massachusetts, 02122, United States

Location

MGH Revere

Revere, Massachusetts, United States

Location

Central Harlem Senior Citizens' Center

New York, New York, 10037, United States

Location

Hamilton Madison City Hall Senior Center

New York, New York, 10038, United States

Location

University of Puerto Rico

San Juan, PR, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 36339195 DERIVED

• 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.

  PMID: 32885198 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Margarita Alegria, PI
• Organization: Disparities Research Unit, MGH

malegria@mgh.harvard.edu

617-724-1237

Study Officials

• Margarita Alegria, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Disparities Research Unit

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: December 16, 2014
• Study Start: July 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-04

Locations

PR (1); US (7)