NCT03105973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

April 4, 2017

Last Update Submit

January 23, 2020

Conditions

DepressionAnxietyMood

Keywords

jailprisontechnologydepressionCBT

Outcome Measures

Primary Outcomes (3)

  • Beck Depression Inventory (BDI)

    Inventory of depression items

    4 weeks

  • Generalized Anxiety Disorder - 7 (GAD-7)

    Inventory of anxiety items

    4 weeks

  • PTSD Checklist-Civilian Version (PCL-17)

    Inventory of PTSD items

    4 weeks

Secondary Outcomes (1)

  • User satisfaction - users

    4 weeks

Study Arms (1)

Open-Label Trial Arm

EXPERIMENTAL

Will receive 4 weeks of technology-enabled CBT treatment.

Behavioral: Technology-Enabled CBT Treatment

Interventions

Technology-Enabled CBT TreatmentBEHAVIORAL

CBT-based modules delivered via tablet over 4 weeks.

Open-Label Trial Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Incarcerated Middlesex County Jail or Woodford County jails;
  • Has access to the Edovo tablet;
  • is at least 18 years of age;

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Woodford County Jail

Eureka, Illinois, 61530, United States

Location

Middlesex County Jail

Billerica, Massachusetts, 01862, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 10, 2017

Study Start

October 1, 2018

Primary Completion

December 31, 2018

Study Completion

January 15, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)