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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03105973
Other study ID # MHRP-MOOD-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date January 15, 2019

Study information

Verified date January 2020
Source Jail Education Solutions, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 15, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Technology-Enabled CBT Treatment
CBT-based modules delivered via tablet over 4 weeks.

Locations

Country Name City State
United States Middlesex County Jail Billerica Massachusetts
United States Woodford County Jail Eureka Illinois

Sponsors (2)

Lead Sponsor Collaborator
Jail Education Solutions, Inc. University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Beck Depression Inventory (BDI) Inventory of depression items 4 weeks
Primary Generalized Anxiety Disorder - 7 (GAD-7) Inventory of anxiety items 4 weeks
Primary PTSD Checklist-Civilian Version (PCL-17) Inventory of PTSD items 4 weeks
Secondary User satisfaction - users How much users like the module 4 weeks
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