Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
427 participants
INTERVENTIONAL
2021-02-11
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Margarita Alegria, PhD
Chief, Disparities Research Unit
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2019P001292
Identifier Type: -
Identifier Source: org_study_id
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