Positive Minds Strong Bodies Implementation

Depression Clinical Trial

— PMSB-E  

Official title:

Building Community Capacity for Disability Prevention for Minority Elders - Renewal

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04545593
• Other study ID #: 2019P001292
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to address treatment and service disparities and prevent disability among racial/ethnic and linguistic minority elders. It tests the effectiveness and implementation readiness of the Positive Minds-Strong Bodies Enhanced intervention (PMSB-E), a combined mental and physical health intervention designed to be implemented in low-resource community settings. This renewal grant project includes a streamlined intervention with new components designed to improve and maintain participant outcomes.

Description:

The Positive Minds-Strong Bodies Enhanced intervention addresses the dual challenges of mental health and physical disability among minority elders. The core Positive Minds intervention includes 10 sessions offered by Community Health Workers over a maximum of 6 months, designed to identify and correct negative distortions or cognitions, promote behavioral activation and encourage supportive relationships. Strong Bodies is a 36-session physical intervention consisting of a series of exercises conducted while wearing a weighted vest in a group setting over 6 months; both interventions include a group maintenance component to maintain gains. The investigators will evaluate the acceptability, effectiveness and twelve-month sustainability of the Enhanced Positive Minds-Strong Bodies intervention (E-PMSB) offered by Community Health Workers (CHWs) and Exercise Trainers in community-based organizations (CBOs) and community clinics. The intervention is offered in English, Spanish, Mandarin or Cantonese.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 427
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Latino, Asian, Black, or non-Latino White adults 60+ years of age

• With mild, moderate or severe depressive or anxiety symptoms.

• Participants receiving medications for mental health will have this recorded and used as a covariate.

• Community-dwelling participants who have some mobility limitations but are not home-bound.

Exclusion Criteria:

• Any specialty mental health care (therapy sessions with psychiatrist, psychologist or social worker) in the past 3 months or scheduled in the coming month.

• Evidence that patient lacks capacity to consent or is cognitively impaired

• Current suicidal risk (score of 4 or 5 on Paykel suicide questionnaire), whereby participant will be connected to an emergency services or specialty provider per the study emergency protocol.

• Physically instability, acute or exacerbation of a chronic disease, or a neuro-musculoskeletal impairment

• Severe substance abuse

• Self-reported psychosis or schizophrenia

• Inability to commit to 2 sessions per week

Related Conditions & MeSH terms

• Anxiety
• Depression
• Physical Disability

Intervention

Behavioral:
• Positive Minds Strong Bodies Enhanced
The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) was designed to provide a single, integrated program that could address the dual challenges of mental health and disability among minority elders. PMSB-E seeks to improve mood symptoms, identify and correct negative distortions or cognitions, promote behavioral activation through engaging the participant in pleasant activities, and encourage developing supportive relationships. All sessions are tailored to the participant's needs using a collaborative approach.
• Enhanced Usual Care
Participants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. Research staff will call the participant 4 times over the course of 6 months to administer mental health items, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	>/= 70% of participants attending >/= 50% of their intervention sessions, reporting satisfaction with treatment.	6 months at end of treatment
Primary	Hopkins Symptom Checklist-25 (change)	Widely used measure of depression and anxiety in clinical monitoring and outcome assessment.	Baseline and 3, 6, and 12 months after baseline
Primary	Short Physical Performance Battery (change)	Assessment of standing balance, timed 4-m walk, and timed test of five chair-rise repetitions, to assess functional limitations. A virtual option will be used while in person assessment is not possible due to COVID-19.	Baseline and 3, 6, and 12 months after baseline
Primary	Late-Life Function and Disability Instrument (LLFDI) - functional component (change)	Self-report instrument designed to measure both functional capacity and components of disability.	Baseline and 3, 6, and 12 months after baseline