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

• 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: Massachusetts General Hospital
• Collaborators: New York University; Vanderbilt University
• Information provided by (Responsible Party): Margarita Alegria, PhD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: November 12, 2014
• First Posted Date: December 16, 2014
• Results First Submitted Date: March 1, 2021
• Results First Posted Date: April 28, 2021
• Last Update Posted Date: April 28, 2021
• Study Start Date: July 2015
• Actual Primary Completion Date: March 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 2, 2021)

• 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".
• 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.
• 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.
• 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.
• 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.
• 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.

Original Primary Outcome Measures (submitted: December 15, 2014)

• Percentage of participants attending more than 50% of CBT sessions. [ Time Frame: 3 months post-baseline ]
  >/= 70% of participants attending >50% of their intervention sessions and reporting satisfaction with treatment
• Change in depressive symptoms from baseline, at multiple follow-up periods. [ Time Frame: 3, 6, and 12 months post-baseline ]
  As measured by the Hopkins Symptom Checklist (HSCL-25)
• Change in functional limitations from baseline, at multiple follow-up periods. [ Time Frame: 3, 6, and 12 months post-intervention ]
  As measured by the Short Physical Performance Battery (SPPB)
• Change in self-reported disability from baseline, at multiple follow-up periods. [ Time Frame: 3, 6, and 12 months post-intervention ]
  As measured by the functional component of the Late Life Function and Disability Instrument (LLFDI)
• Change in number of disability days from baseline, at multiple follow-up periods. [ Time Frame: 3, 6, and 12 months post-intervention ]
  As measured by the World Health Organization Disability Assessment Schedule (WHO-DAS)
• Change in anxiety symptoms from baseline, at multiple follow-up periods [ Time Frame: 3, 6, and 12 months post intervention ]
  As measured by the Beck Anxiety Inventory (BAI)

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)
• Official Title: Building Community Capacity for Disability Prevention for Minority Elders
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Depression
• Anxiety
• Physical Disability

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

Study Arms

• Experimental: CBT + InVEST exercise
  10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
  Intervention: 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.
  Intervention: Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2018): 307
• Original Estimated Enrollment (submitted: December 15, 2014): 360
• Actual Study Completion Date: March 1, 2019
• Actual Primary Completion Date: March 1, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT02317432
• Other Study ID Numbers: 1R01AG046149-01A1( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Margarita Alegria, PhD, Massachusetts General Hospital
• Original Responsible Party: Margarita Alegria, PhD, Cambridge Health Alliance, Director, Center for Multicultural Mental Health Research
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Cambridge Health Alliance

Collaborators

• New York University
• Vanderbilt University

Investigators

• Principal Investigator: Margarita Alegria, PhD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: April 2021