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Mental and Physical Health Intervention for Preventing Disability in Minority Elders (PMSB-E Trial)
N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
With mild, moderate or severe depressive or anxiety symptoms.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3, 6, and 12 months after baseline
Awards & highlights
PMSB-E Trial Summary
This trial tests a new mental and physical health intervention for racial/ethnic and linguistic minority elders to address treatment and service disparities and prevent disability.
Who is the study for?
This trial is for Latino, Asian, Black, or non-Latino White adults over 60 with mild to severe anxiety or depression and some mobility issues but not home-bound. They must be able to attend two sessions weekly and can't have cognitive impairments, current high suicide risk, severe substance abuse, psychosis/schizophrenia history, recent specialty mental health care or physical instability.Check my eligibility
What is being tested?
The study tests the Positive Minds-Strong Bodies Enhanced intervention (PMSB-E), designed for low-resource community settings to improve mental and physical health in minority elders. It compares PMSB-E against enhanced usual care to see which is more effective at preventing disability.See study design
What are the potential side effects?
Since this trial involves a non-drug intervention focusing on mental and physical exercises rather than medications, typical drug side effects are not expected. However, participants may experience discomfort from new activities or emotional distress during therapy.
PMSB-E Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience symptoms of depression or anxiety.
PMSB-E Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3, 6, and 12 months after baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3, 6, and 12 months after baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability
Hopkins Symptom Checklist-25 (change)
Late-Life Function and Disability Instrument (LLFDI) - functional component (change)
+1 morePMSB-E Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Positive Minds Strong Bodies EnhancedExperimental Treatment1 Intervention
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.
Group II: Enhanced Usual CareActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,031 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently stable and do not have any worsening chronic diseases or physical impairments.I live at home and can move around but with some difficulty.My mental health medications will be noted for the study.I am unable to make medical decisions due to cognitive impairment.I have seen or plan to see a mental health specialist recently.I experience symptoms of depression or anxiety.I am 60 or older and identify as Latino, Asian, Black, or non-Latino White.You are currently at high risk for suicide, and the study has an emergency plan in place to connect you with specialized care if needed.You have a serious problem with drug or alcohol abuse.You have been diagnosed with schizophrenia or psychosis according to your own report.
Research Study Groups:
This trial has the following groups:- Group 1: Positive Minds Strong Bodies Enhanced
- Group 2: Enhanced Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are partaking in this medical experiment?
"Affirmative. Clinicaltrials.gov records demonstrate that this experiment, posted on February 11th 2021 and updated on April 4th 2022, is in the process of recruiting participants. The study requires 450 individuals from a solitary location to participate."
Answered by AI
Are there any available openings for participants in this clinical research?
"Yes, the data on clinicaltrials.gov confirm that this study is actively enrolling patients. Starting from February 11th 2021 and having been recently updated in April 4th 2022, it aims to recruit 450 individuals at a single medical centre."
Answered by AI
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