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Positive Minds Strong Bodies Implementation (PMSB-E)

Primary Purpose

Depression, Anxiety, Physical Disability

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Positive Minds Strong Bodies Enhanced

Enhanced Usual Care

About this trial

This is an interventional treatment trial for Depression focused on measuring Minority Elders

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive Minds Strong Bodies Enhanced

Enhanced Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Acceptability

>/= 70% of participants attending >/= 50% of their intervention sessions, reporting satisfaction with treatment.

Hopkins Symptom Checklist-25 (change)

Widely used measure of depression and anxiety in clinical monitoring and outcome assessment.

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.

Late-Life Function and Disability Instrument (LLFDI) - functional component (change)

Self-report instrument designed to measure both functional capacity and components of disability.

Secondary Outcome Measures

Full Information

NCT ID

NCT04545593

First Posted

September 4, 2020

Last Updated

April 4, 2022

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04545593

Brief Title

Positive Minds Strong Bodies Implementation

Acronym

PMSB-E

Official Title

Building Community Capacity for Disability Prevention for Minority Elders - Renewal

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2021 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Anxiety, Physical Disability

Keywords

Minority Elders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Research staff conducting follow up assessments will be blinded to participant condition in the trial.

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Positive Minds Strong Bodies Enhanced

Arm Type

Experimental

Arm Description

Arm Title

Enhanced Usual Care

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Positive Minds Strong Bodies Enhanced

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Enhanced Usual Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Acceptability

Description

>/= 70% of participants attending >/= 50% of their intervention sessions, reporting satisfaction with treatment.

Time Frame

6 months at end of treatment

Title

Hopkins Symptom Checklist-25 (change)

Description

Widely used measure of depression and anxiety in clinical monitoring and outcome assessment.

Time Frame

Baseline and 3, 6, and 12 months after baseline

Title

Short Physical Performance Battery (change)

Description

Time Frame

Baseline and 3, 6, and 12 months after baseline

Title

Late-Life Function and Disability Instrument (LLFDI) - functional component (change)

Description

Self-report instrument designed to measure both functional capacity and components of disability.

Time Frame

Baseline and 3, 6, and 12 months after baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Margarita Alegria, Ph.D.

Phone

(617) 724-4987

malegria@mgh.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sheri Markle, MIA

Phone

617-643-5042

smarkle@mgh.harvard.edu

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Margarita Alegria, PhD

Phone

617-724-4987

malegria@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Sheri L Markle, MIA

Phone

617-643-5042

smarkle@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Positive Minds Strong Bodies Implementation

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