- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02317432
Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)
April 2, 2021 updated by: Margarita Alegria, PhD, Massachusetts General Hospital
Building Community Capacity for Disability Prevention for Minority Elders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
307
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico
- University of Puerto Rico
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Florida
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Aventura, Florida, United States, 33180
- King David Foundation
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Greater Boston Chinese Golden Age Center
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Chelsea, Massachusetts, United States
- MGH Chelsea
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Dorchester, Massachusetts, United States, 02122
- Kit Clark Senior Services
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Revere, Massachusetts, United States
- MGH Revere
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New York
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New York, New York, United States, 10037
- Central Harlem Senior Citizens' Center
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New York, New York, United States, 10038
- Hamilton Madison City Hall Senior Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CBT + InVEST exercise
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
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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.
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What is the study measuring?
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
Time Frame: 6-months post-baseline
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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".
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6-months post-baseline
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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
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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.
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6-months post-baseline
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Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up
Time Frame: 6-months post-baseline
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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.
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6-months post-baseline
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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
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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.
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6-months post-baseline
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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
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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.
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6-months post-baseline
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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
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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.
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6-moths post-baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Margarita Alegria, PhD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
November 12, 2014
First Submitted That Met QC Criteria
December 15, 2014
First Posted (Estimate)
December 16, 2014
Study Record Updates
Last Update Posted (Actual)
April 28, 2021
Last Update Submitted That Met QC Criteria
April 2, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01AG046149-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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