DepressionNCT03105973
Technology Enabled Mental Health Intervention for Individuals in the Criminal Justice System
A study testing Technology-Enabled CBT Treatment in people with Depression and Anxiety, run by Jail Education Solutions, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Mood
- What is being tested?
- Technology-Enabled CBT Treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2018to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Middlesex County Jail
Billerica, Massachusetts, 01862
Woodford County Jail
Eureka, Illinois, 61530
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety, Mood
- Being tested
- Technology-Enabled CBT Treatment
- Keywords
- jail, prison, technology, depression, CBT
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-Enabled CBT TreatmentBehavioural
CBT-based modules delivered via tablet over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Trial Arm | Experimental | Will receive 4 weeks of technology-enabled CBT treatment. Receives: Behavioral: Technology-Enabled CBT Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI)
Inventory of depression items
Measured: 4 weeks
Generalized Anxiety Disorder - 7 (GAD-7)
Inventory of anxiety items
Measured: 4 weeks
PTSD Checklist-Civilian Version (PCL-17)
Inventory of PTSD items
Measured: 4 weeks
Secondary outcomes (1)
User satisfaction - users
How much users like the module
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Oct 2018
- Primary completion31 Dec 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jail Education Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Illinois Chicago
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105973
- Sponsor's protocol ID
- MHRP-MOOD-001
- Status last verified
- Jan 2020
- First submitted
- 4 Apr 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Enabled Mental Health Intervention for Individuals in the Criminal Justice System
- ClinicalTrials.gov ID
- NCT03105973
- Acronym / sponsor ID
- MHRP-MOOD-001
- Conditions
- Depression, Anxiety, Mood
- Keywords
- jail, prison, technology, depression, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jail Education Solutions, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Illinois Chicago
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label trial
| Arm | Type | Receives |
|---|---|---|
| Open-Label Trial Arm | Experimental | Behavioral: Technology-Enabled CBT TreatmentWill receive 4 weeks of technology-enabled CBT treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-Enabled CBT TreatmentCBT-based modules delivered via tablet over 4 weeks. | Behavioural | Open-Label Trial Arm |
Primary outcome
Beck Depression Inventory (BDI)
Time frame: 4 weeks
Inventory of depression items
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: 4 weeks
Inventory of anxiety items
PTSD Checklist-Civilian Version (PCL-17)
Time frame: 4 weeks
Inventory of PTSD items
1 secondary outcome
User satisfaction - users
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-Enabled CBT Treatment in people with Depression and Anxiety, run by Jail Education Solutions, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (BDI) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.