AlcoholismTETATNCT02674477
Treatment Engagement With Technology-assisted Treatment
A study testing Therapeutic Education System (TES) and Treatment as Usual (TAU) in people with Alcoholism and Substance-related Disorders, run by Johns Hopkins University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Substance-related Disorders, Mentally Ill Chemical Abuse
- What is being tested?
- Therapeutic Education System (TES) and Treatment as Usual (TAU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 29 Feb 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- psychotic symptoms, such as hearing voices
- involuntary admission
About this study
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.
Read the 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
- Being tested
- Therapeutic Education System (TES), Treatment as Usual (TAU)
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Education System (TES)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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 30 days after discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start29 Feb 2016
- Primary completionJun 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Strain, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674477
- Sponsor's protocol ID
- IRB00079236
- Acronym
- TETAT
- Status last verified
- Aug 2019
- First submitted
- 29 Jan 2016
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 24634641Campbell 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.
PubMed 24700332Hammond 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.
PubMed 32701419
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Engagement With Technology-assisted Treatment
- ClinicalTrials.gov ID
- NCT02674477
- Acronym / sponsor ID
- TETAT / IRB00079236
- Conditions
- Alcoholism, Substance-related Disorders, Mentally Ill Chemical Abuse, Educational Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Education System (TES) | Experimental | Device: 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. |
| Treatment as Usual (TAU) | Other | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- psychotic symptoms, such as hearing voices
- involuntary admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Therapeutic Education System (TES) |
| 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. | Other | Treatment as Usual (TAU) |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24634641Chaple 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.
- Background: PubMed 24700332Campbell 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.
- Derived from this study: PubMed 32701419Hammond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Strain, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Education System (TES) and Treatment as Usual (TAU) in people with Alcoholism and Substance-related Disorders, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Treatment Based on Survey Questionnaire Completed by Participants (time frame: prior to discharge from the hospital up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02674477, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.