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Positive Minds Strong Bodies Implementation (PMSB-E)

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ClinicalTrials.gov Identifier: NCT04545593
Recruitment Status : Recruiting
First Posted : September 11, 2020
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Margarita Alegria, PhD, Massachusetts General Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Physical Disability Behavioral: Positive Minds Strong Bodies Enhanced Behavioral: Enhanced Usual Care Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Research staff conducting follow up assessments will be blinded to participant condition in the trial.
Primary Purpose: Treatment
Official Title: Building Community Capacity for Disability Prevention for Minority Elders - Renewal
Actual Study Start Date : February 11, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Positive Minds Strong Bodies Enhanced
The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) consists of 10 sessions focused on mental health (PM) and 36 sessions focused on physical health (SB), along with a group maintenance component.
 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.
Active Comparator: Enhanced Usual Care
The Enhanced Usual Care condition includes written materials on depression and anxiety and 4 calls to participants over the course of 6 months to assess symptoms and safety.
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Acceptability [ Time Frame: 6 months at end of treatment ]
    >/= 70% of participants attending >/= 50% of their intervention sessions, reporting satisfaction with treatment.

  2. Hopkins Symptom Checklist-25 (change) [ Time Frame: Baseline and 3, 6, and 12 months after baseline ]
    Widely used measure of depression and anxiety in clinical monitoring and outcome assessment.

  3. Short Physical Performance Battery (change) [ Time Frame: Baseline and 3, 6, and 12 months after baseline ]
    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.

  4. Late-Life Function and Disability Instrument (LLFDI) - functional component (change) [ Time Frame: Baseline and 3, 6, and 12 months after baseline ]
    Self-report instrument designed to measure both functional capacity and components of disability.


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:   No
Criteria

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
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): NCT04545593


Contacts
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Contact: Margarita Alegria, Ph.D. (617) 724-4987 malegria@mgh.harvard.edu
Contact: Sheri Markle, MIA 617-643-5042 smarkle@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Margarita Alegria, PhD    617-724-4987    malegria@mgh.harvard.edu   
Contact: Sheri L Markle, MIA    617-643-5042    smarkle@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
More Information
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Responsible Party: Margarita Alegria, PhD, Chief, Disparities Research Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04545593    
Other Study ID Numbers: 2019P001292
First Posted: September 11, 2020    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margarita Alegria, PhD, Massachusetts General Hospital:
Minority Elders
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms