- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03105973
Technology Enabled Mental Health Intervention for Individuals in the Criminal Justice System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the United States, over 2.2 million people are incarcerated. While these numbers are alarming, even more distressing is the rapid growth in the number of mentally ill individuals caught in this system. Within any given year, approximately 73% of females and 55% of males in jail will experience a mental health problem. This results in the criminal justice system serving as a de facto mental health treatment facility for hundreds of thousands of individuals, despite constrained funding and a paucity of qualified providers and interventions. More than one in five jails have no access to mental health services.
There is strong evidence that technology-enabled interventions for the treatment of mood disorders are efficacious and cost effective. Technology-enabled mental health care has many strengths, including the ability to deliver treatment reliably, increase privacy for those seeking services, and provide a scalable evidence-based intervention at a lower cost than traditional face-to-face services.
Edovo has previously developed secure tablet hardware, protected networks and a learning management system that deliver static content in the areas of academic, job skill, and life skill programming to those incarcerated. The aim of this project is to develop and demonstrate the feasibility of a dynamic intervention for the treatment of inmates with mood disorders utilizing the Edovo system. A user centered design approach will be used to modify existing evidence-based, technology-enabled mood interventions to be appropriate for the incarcerated population. Software will be modified to run the intervention on the existing Edovo system. The resulting intervention will be tested in a sample of inmates for an initial clinical signal. The development of such a technology would help correctional facilities more effectively meet their treatment requirements and rehabilitation goals.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Eureka, Illinois, United States, 61530
- Woodford County Jail
-
-
Massachusetts
-
Billerica, Massachusetts, United States, 01862
- Middlesex County Jail
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Incarcerated Middlesex County Jail or Woodford County jails;
- Has access to the Edovo tablet;
- is at least 18 years of age;
- Is able to speak and read English Exclusion Criteria
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Open-Label Trial Arm
Will receive 4 weeks of technology-enabled CBT treatment.
|
CBT-based modules delivered via tablet over 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory (BDI)
Time Frame: 4 weeks
|
Inventory of depression items
|
4 weeks
|
|
Generalized Anxiety Disorder - 7 (GAD-7)
Time Frame: 4 weeks
|
Inventory of anxiety items
|
4 weeks
|
|
PTSD Checklist-Civilian Version (PCL-17)
Time Frame: 4 weeks
|
Inventory of PTSD items
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User satisfaction - users
Time Frame: 4 weeks
|
How much users like the module
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHRP-MOOD-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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