Treatment Engagement With Technology-assisted Treatment

NCT ID: NCT02674477

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-09-30

Brief 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.

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.

Conditions

Alcoholism; Substance-related Disorders; Mentally Ill Chemical Abuse; Educational Technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapeutic Education System (TES)

Intervention Type: DEVICE

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.

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.

Group Type: OTHER

Treatment as Usual (TAU)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Strain, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

References

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.

Reference Type: BACKGROUND

PMID: 24634641 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24700332 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32701419 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00079236

Identifier Type: -

Identifier Source: org_study_id