NCT02674477

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

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

January 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

February 29, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 19, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

January 29, 2016

Results QC Date

June 25, 2019

Last Update Submit

August 7, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of Participants Enrolled in Post-discharge Substance Abuse Treatment Appointments 30 Days After Hospital Discharge

    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

    30 days after discharge from the hospital

Study Arms (2)

Therapeutic Education System (TES)

EXPERIMENTAL

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.

Device: Therapeutic Education System (TES)

Treatment as Usual (TAU)

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.

Other: Treatment as Usual (TAU)

Interventions

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.

Therapeutic Education System (TES)

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.

Treatment as Usual (TAU)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • psychotic symptoms, such as hearing voices
  • involuntary admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24634641BACKGROUND
  • 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.

    PMID: 24700332BACKGROUND
  • 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.

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Alexis Hammond
Organization
Johns Hopkins University

Study Officials

  • Eric Strain, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 4, 2016

Study Start

February 29, 2016

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

August 22, 2019

Results First Posted

July 19, 2019

Record last verified: 2019-08