Clinical trial NCT02317432: Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)
Official title: Building Community Capacity for Disability Prevention for Minority Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Physical Disability
Keywords: Depression
Anxiety
Disability
Ethnic Minority
Elders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: New York University
name: Vanderbilt University
First posted: 2014-12-16
Enrollment: 307
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions
timeFrame: 6-months post-baseline
measure: Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up
timeFrame: 6-months post-baseline
measure: Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up
timeFrame: 6-months post-baseline
measure: 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.
timeFrame: 6-months post-baseline
measure: 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.
timeFrame: 6-months post-baseline
measure: Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up
timeFrame: 6-moths post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aventura
country: United States
facility: King David Foundation
state: Florida
city: Boston
country: United States
facility: Greater Boston Chinese Golden Age Center
state: Massachusetts
city: Chelsea
country: United States
facility: MGH Chelsea
state: Massachusetts
city: Dorchester
country: United States
facility: Kit Clark Senior Services
state: Massachusetts
city: Revere
country: United States
facility: MGH Revere
state: Massachusetts
city: New York
country: United States
facility: Central Harlem Senior Citizens' Center
state: New York
city: New York
country: United States
facility: Hamilton Madison City Hall Senior Center
state: New York
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: Massachusetts General Hospital
name: Margarita Alegria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.