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Treatment Engagement With Technology-assisted Treatment (TETAT)

Primary Purpose

Alcoholism, Substance-related Disorders, Mentally Ill Chemical Abuse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic Education System (TES)
Treatment as Usual (TAU)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Therapeutic Education System (TES)

    Treatment as Usual (TAU)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Number of Participants Enrolled in Post-discharge Substance Abuse Treatment Appointments 30 Days After Hospital Discharge
    Number of Participants Enrolled in Post-discharge Treatment for Other Mental Health Appointments 30 Days After Hospital Discharge

    Full Information

    First Posted
    January 29, 2016
    Last Updated
    August 7, 2019
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02674477
    Brief Title
    Treatment Engagement With Technology-assisted Treatment
    Acronym
    TETAT
    Official Title
    Treatment Engagement With Technology-assisted Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 29, 2016 (Actual)
    Primary Completion Date
    June 2018 (Actual)
    Study Completion Date
    September 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcoholism, Substance-related Disorders, Mentally Ill Chemical Abuse, Educational Technology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    95 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapeutic Education System (TES)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Treatment as Usual (TAU)
    Arm Type
    Other
    Arm Description
    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
    Device
    Intervention Name(s)
    Therapeutic Education System (TES)
    Intervention Description
    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
    Other
    Intervention Name(s)
    Treatment as Usual (TAU)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Acceptability of Treatment Based on Survey Questionnaire Completed by Participants
    Description
    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.
    Time Frame
    prior to discharge from the hospital up to 30 days
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eric Strain, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24634641
    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(1):105-127. doi: 10.1007/s11292-013-9187-y.
    Results Reference
    background
    PubMed Identifier
    24700332
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32701419
    Citation
    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.
    Results Reference
    derived

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    Treatment Engagement With Technology-assisted Treatment

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