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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02317432
Recruitment Status : Completed
First Posted : December 16, 2014
Results First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Collaborators:
New York University
Vanderbilt University
Information provided by (Responsible Party):
Margarita Alegria, PhD, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Physical Disability Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Building Community Capacity for Disability Prevention for Minority Elders
Study Start Date : July 2015
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: CBT + InVEST exercise
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
Active Comparator: Enhanced Usual Care
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions [ Time Frame: 6-months post-baseline ]
    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".

  2. Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up [ Time Frame: 6-months post-baseline ]
    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.

  3. Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up [ Time Frame: 6-months post-baseline ]
    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.

  4. 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. [ Time Frame: 6-months post-baseline ]
    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.

  5. 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. [ Time Frame: 6-months post-baseline ]
    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. Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up [ Time Frame: 6-moths post-baseline ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317432


Locations
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United States, Florida
King David Foundation
Aventura, Florida, United States, 33180
United States, Massachusetts
Greater Boston Chinese Golden Age Center
Boston, Massachusetts, United States, 02111
MGH Chelsea
Chelsea, Massachusetts, United States
Kit Clark Senior Services
Dorchester, Massachusetts, United States, 02122
MGH Revere
Revere, Massachusetts, United States
United States, New York
Central Harlem Senior Citizens' Center
New York, New York, United States, 10037
Hamilton Madison City Hall Senior Center
New York, New York, United States, 10038
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
Massachusetts General Hospital
New York University
Vanderbilt University
Investigators
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Principal Investigator: Margarita Alegria, PhD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Margarita Alegria, PhD, Massachusetts General Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] April 2, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Margarita Alegria, PhD, Chief, Disparities Research Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02317432    
Other Study ID Numbers: 1R01AG046149-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 16, 2014    Key Record Dates
Results First Posted: April 28, 2021
Last Update Posted: April 28, 2021
Last Verified: April 2021
Keywords provided by Margarita Alegria, PhD, Massachusetts General Hospital:
Depression
Anxiety
Disability
Ethnic Minority
Elders
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms