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Peer Navigation for Psychiatric Disabilities (DRRRP-PHN Trial)
N/A
Recruiting
Led By Patrick W Corrigan, PsyD
Research Sponsored by Illinois Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older
Be older than 18 years old
Must not have
Currently receiving Assertive Community Treatment services
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 months, 8 months, 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a peer navigator program can help adults with psychiatric disabilities improve their physical health and wellness.
Who is the study for?
This trial is for adults over 18 with serious mental illness who want to improve their physical health and wellness. They must be active members of Thresholds in the Chicago South Side area, willing to attend sessions but not already receiving peer support or Assertive Community Treatment services.
What is being tested?
The study tests a Peer Navigator Program (PNP) against usual integrated care. PNP uses peers with similar backgrounds and recovery experiences to help participants navigate healthcare services. The goal is better engagement, health, recovery, and quality of life.
What are the potential side effects?
Since this intervention involves peer navigation rather than medication, traditional side effects are not expected. However, there may be emotional or social impacts due to the nature of personal interactions within the program.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently getting support from a community mental health team.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 months, 8 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 months, 8 months, 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 from Baseline in 36-Item Short Form Health Survey (SF-36) Scores at Months 4, 8, and 12
Change from Baseline in Texas Christian University Health Form (TCU-HLTHFORM) Scores at Months 4, 8, and 12
Secondary study objectives
Change from Baseline in COVID-19 Social Distancing and Hygiene Scale Scores at Months 4, 8, and 12
Change from Baseline in Center for Epidemiologic Studies Depression Scale-Depression 10-item version (CES-D 10) Scores at Months 4, 8, and 12
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scores at Months 4, 8, and 12
+7 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
Active Control
Group I: Peer Navigator Program (PNP)Experimental Treatment1 Intervention
Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* scheduling and attending healthcare appointments;
* partnering with participant on tasks that arise from appointments;
* health-related goal setting; and
* taking action-steps toward health-related goals.
Group II: Treatment as Usual-Integrated Care (TAU-IC)Active Control1 Intervention
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-half of research participants will be randomized to integrated care alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peer Navigation
2016
N/A
~890
Find a Location
Who is running the clinical trial?
Arizona State UniversityOTHER
299 Previous Clinical Trials
107,631 Total Patients Enrolled
Illinois Institute of TechnologyLead Sponsor
24 Previous Clinical Trials
14,833 Total Patients Enrolled
Thresholds Inc.Industry Sponsor
3 Previous Clinical Trials
455 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I want to better my health and prevent illness with the help of a health guide.I am currently getting support from a community mental health team.I am working with a peer support specialist on my health goals.I want to better my health and prevent illness with the help of a health guide.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual-Integrated Care (TAU-IC)
- Group 2: Peer Navigator Program (PNP)
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.
Psychiatric Disorder Patient Testimony for trial: Trial Name: NCT05018351 — N/A
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