Technology Enabled Mental Health Intervention for Individuals in the Criminal Justice System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03105973
Recruitment Status : Not yet recruiting
First Posted : April 10, 2017
Last Update Posted : April 12, 2017
University of Illinois at Chicago
Information provided by (Responsible Party):
Jail Education Solutions, Inc.

Brief Summary:
In the United States, over 60% of the 2.2 million people who are incarcerated struggle with mental health problems. Currently, correctional facilities are limited in their ability to provide care. As technology-enabled interventions for mood disorders have demonstrated efficacy outside of correctional facilities, the investigators propose to build and test a technology-enabled mood disorder treatment intervention for individuals who are incarcerated.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Depression Mood Disorders Other: Technology-Enabled CBT Treatment Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Technology Enabled Mental Health Intervention for Individuals in the Criminal Justice System
Estimated Study Start Date : April 15, 2017
Estimated Primary Completion Date : September 1, 2017
Estimated Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Open-Label Trial Arm
Will receive 4 weeks of technology-enabled CBT treatment.
Other: Technology-Enabled CBT Treatment
CBT-based modules delivered via tablet over 4 weeks.

Primary Outcome Measures :
  1. Beck Depression Inventory (BDI) [ Time Frame: 4 weeks ]
    Inventory of depression items

  2. Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: 4 weeks ]
    Inventory of anxiety items

  3. PTSD Checklist-Civilian Version (PCL-17) [ Time Frame: 4 weeks ]
    Inventory of PTSD items

Secondary Outcome Measures :
  1. User satisfaction - users [ Time Frame: 4 weeks ]
    How much users like the module

  2. User satisfaction - correctional facility staff [ Time Frame: 4 weeks ]
    How much correctional facility staff like the module

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Reside in General Population pod of the Allegheny County Jail

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03105973

Contact: Kevin Pujanauski

Sponsors and Collaborators
Jail Education Solutions, Inc.
University of Illinois at Chicago

Responsible Party: Jail Education Solutions, Inc. Identifier: NCT03105973     History of Changes
Other Study ID Numbers: MHRP-MOOD-001
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jail Education Solutions, Inc.:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders