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IIMR vs CDSMP for Mental Health Disorders
N/A
Recruiting
Led By Sarah Pratt
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serious Mental Illness (diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or chronic depression with moderate impairment in functioning) receiving services at Centerstone(KY and TN)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two different interventions for people with serious mental illness to see which is more effective.
Who is the study for?
This trial is for people with serious mental illnesses like schizophrenia or bipolar disorder, who also have a chronic physical condition such as diabetes or heart disease. They should have had an ER visit or hospitalization in the past year and need help managing their health. It's only for those receiving services at Centerstone in KY or TN and who speak English.
What is being tested?
The study compares two programs: I-IMR, which helps people with serious mental illness manage both physical and mental health, and CDSMP, focused on managing physical health conditions. The goal is to see which program better supports individuals' self-management of their chronic diseases.
What are the potential side effects?
Since this trial involves educational interventions rather than medications, traditional side effects are not applicable. However, participants may experience stress or discomfort when discussing personal health issues during the programs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a serious mental illness and am getting help from Centerstone in KY or TN.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Acute Hospital Events from Electronic Medical Record Review.
Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale
Change in Patient Activation on the Patient Activation Measure (PAM)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stanford Chronic Disease Self-Management Program (CDSMP):Experimental Treatment1 Intervention
Participants randomly assigned get a 6-session group-based educational program co-delivered by two peers (lay people who have successfully managed a chronic illness) or a peer and a professional
Group II: Integrated Illness Management and Recovery (I-IMR):Experimental Treatment1 Intervention
Participants assigned to I-IMR will receive 2 individual sessions to discuss principles of recovery and set personally meaningful goals, with the remainder of the 14 I-IMR sessions delivered in groups of 8-10 (to enable individual tailoring)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Integrated Illness Management and Recovery
2020
N/A
~170
Chronic Disease Self-Management Program
2015
N/A
~1320
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Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
537 Previous Clinical Trials
2,539,453 Total Patients Enrolled
4 Trials studying Chronic Disease
1,863 Patients Enrolled for Chronic Disease
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,078,532 Total Patients Enrolled
14 Trials studying Chronic Disease
221,880 Patients Enrolled for Chronic Disease
Sarah PrattPrincipal InvestigatorDartmouth-Hitchcock Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a test that measures how well your brain is working, called the Mini Mental Status Examination. If your score is less than 24, it means you have significant problems with your thinking and memory.I have a chronic condition like diabetes or heart disease and was hospitalized or visited the ER last year.I have a serious mental illness and am getting help from Centerstone in KY or TN.
Research Study Groups:
This trial has the following groups:- Group 1: Integrated Illness Management and Recovery (I-IMR):
- Group 2: Stanford Chronic Disease Self-Management Program (CDSMP):
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.
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