Positive Minds Strong Bodies Implementation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04545593
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Positive Minds Strong Bodies Enhanced — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 11, 2021
Status verified
Mar 2026
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
427 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Acceptability [ Time Frame: 12 months after baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Massachusetts General Hospital· Boston, MA

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