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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02674477
Other study ID # IRB00079236
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 29, 2016
Est. completion date September 2018

Study information

Verified date August 2019
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date September 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Therapeutic Education System (TES)
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

References & Publications (2)

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. — View Citation

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;10:105-127. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability of Treatment Based on Survey Questionnaire Completed by Participants 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 Number of Participants Enrolled in Post-discharge Substance Abuse Treatment Appointments 30 Days After Hospital Discharge 30 days after discharge from the hospital
Secondary Number of Participants Enrolled in Post-discharge Treatment for Other Mental Health Appointments 30 Days After Hospital Discharge 30 days after discharge from the hospital
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