- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674477
Treatment Engagement With Technology-assisted Treatment (TETAT)
August 7, 2019 updated by: Johns Hopkins University
This research is being done to study whether using an Internet-based program, called the Therapeutic Education System (TES), would be helpful for the treatment of substance use and other psychiatric problems.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
TES has been shown to be helpful as substance abuse treatment in certain groups of people, mainly in the outpatient setting by using interactive modules for education.
This study will expose some participants to this program while participants are hospitalized on an inpatient unit, and give the participants access to it after participants are discharged from the hospital.
Those participants will still receive treatment as usual, as will the control group.
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of drug or alcohol problem, plus another psychiatric problem, such as depression or anxiety
- drug or alcohol use in the last 30 days
- proficiency in English
- able to consent to study
- willing to engage in outpatient treatment
- willing to allow study team to contact outpatient providers
Exclusion Criteria:
- psychotic symptoms, such as hearing voices
- involuntary admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Therapeutic Education System (TES)
Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using participant's specific login information.
Participants can use it as much or as little as participants like.
Participants will continue with treatment as usual during and after hospitalization, as well.
|
The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health.
Each module takes less than 30 minutes to complete.
Modules may contain videos or other interactive media.
At the end of each module, there are questions about the material.
|
Other: Treatment as Usual (TAU)
Standard treatment comprises a psychiatrist-led interdisciplinary team as well as face-to-face group counseling for substance use and skills for improving general mental health.
There will be no change to the routine care (treatment at usual [TAU]) provided to patients on the service.
|
Standard treatment comprises a psychiatrist-led interdisciplinary team as well as face-to-face group counseling for substance use and skills for improving general mental health.
There will be no change to the routine care (treatment at usual [TAU]) provided to patients on the service.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Treatment Based on Survey Questionnaire Completed by Participants
Time Frame: prior to discharge from the hospital up to 30 days
|
The acceptability assessment asks about hospital satisfaction for both groups.
The questionnaire is a series of questions on Qualtrics on a scale of 0-10.
Higher scores signified a more positive response and a better outcome.
|
prior to discharge from the hospital up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants Enrolled in Post-discharge Substance Abuse Treatment Appointments 30 Days After Hospital Discharge
Time Frame: 30 days after discharge from the hospital
|
30 days after discharge from the hospital
|
Number of Participants Enrolled in Post-discharge Treatment for Other Mental Health Appointments 30 Days After Hospital Discharge
Time Frame: 30 days after discharge from the hospital
|
30 days after discharge from the hospital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Strain, MD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Campbell AN, Nunes EV, Matthews AG, Stitzer M, Miele GM, Polsky D, Turrigiano E, Walters S, McClure EA, Kyle TL, Wahle A, Van Veldhuisen P, Goldman B, Babcock D, Stabile PQ, Winhusen T, Ghitza UE. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014 Jun;171(6):683-90. doi: 10.1176/appi.ajp.2014.13081055. Erratum In: Am J Psychiatry. 2014 Dec 1;171(12):1338.
- Chaple M, Sacks S, McKendrick K, Marsch LA, Belenko S, Leukefeld C, Prendergast M, French M. Feasibility of a computerized intervention for offenders with substance use disorders: a research note. J Exp Criminol. 2014;10(1):105-127. doi: 10.1007/s11292-013-9187-y.
- Hammond AS, Antoine DG, Stitzer ML, Strain EC. A Randomized and Controlled Acceptability Trial of an Internet-based Therapy among Inpatients with Co-occurring Substance Use and Other Psychiatric Disorders. J Dual Diagn. 2020 Oct;16(4):447-454. doi: 10.1080/15504263.2020.1794094. Epub 2020 Jul 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 29, 2016
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
January 29, 2016
First Submitted That Met QC Criteria
February 2, 2016
First Posted (Estimate)
February 4, 2016
Study Record Updates
Last Update Posted (Actual)
August 22, 2019
Last Update Submitted That Met QC Criteria
August 7, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00079236
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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