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

Primary Purpose

Depression, Anxiety, Mood

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technology-Enabled CBT Treatment
Sponsored by
Jail Education Solutions, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring jail, prison, technology, depression, CBT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Woodford County Jail
  • Middlesex County Jail

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-Label Trial Arm

Arm Description

Will receive 4 weeks of technology-enabled CBT treatment.

Outcomes

Primary Outcome Measures

Beck Depression Inventory (BDI)
Inventory of depression items
Generalized Anxiety Disorder - 7 (GAD-7)
Inventory of anxiety items
PTSD Checklist-Civilian Version (PCL-17)
Inventory of PTSD items

Secondary Outcome Measures

User satisfaction - users
How much users like the module

Full Information

First Posted
April 4, 2017
Last Updated
January 23, 2020
Sponsor
Jail Education Solutions, Inc.
Collaborators
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03105973
Brief Title
Technology Enabled Mental Health Intervention for Individuals in the Criminal Justice System
Official Title
Technology Enabled Mental Health Intervention for Individuals in the Criminal Justice System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jail Education Solutions, Inc.
Collaborators
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Mood
Keywords
jail, prison, technology, depression, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open-label trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Trial Arm
Arm Type
Experimental
Arm Description
Will receive 4 weeks of technology-enabled CBT treatment.
Intervention Type
Behavioral
Intervention Name(s)
Technology-Enabled CBT Treatment
Intervention Description
CBT-based modules delivered via tablet over 4 weeks.
Primary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Description
Inventory of depression items
Time Frame
4 weeks
Title
Generalized Anxiety Disorder - 7 (GAD-7)
Description
Inventory of anxiety items
Time Frame
4 weeks
Title
PTSD Checklist-Civilian Version (PCL-17)
Description
Inventory of PTSD items
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
User satisfaction - users
Description
How much users like the module
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Woodford County Jail
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Middlesex County Jail
City
Billerica
State/Province
Massachusetts
ZIP/Postal Code
01862
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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