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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Strain, MD | Johns Hopkins University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24634641 | Background | 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. | |
| 24700332 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well. 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. |
| FG001 | 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. Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | score on a scale | prior to discharge from the hospital up to 30 days |
|
3 months after discharge from the hospital
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexis Hammond | Johns Hopkins University | 410-550-0045 | ahammon9@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2016 | Apr 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| 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. |
|
| 30 days after discharge from the hospital |
| 32701419 | Derived | 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. |
| BG001 | Treatment as Usual (TAU) | Participants will have the typical treatment during and after their hospitalizations, without additional intervention. Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Treatment as Usual (TAU) | Participants will have the typical treatment during and after their hospitalizations, without additional intervention. Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization. |
|
|
| Secondary | Number of Participants Enrolled in Post-discharge Substance Abuse Treatment Appointments 30 Days After Hospital Discharge | We only analyzed those who were referred to substance abuse treatment, and for whom we were able to receive the information from their treatment program | Posted | Count of Participants | Participants | 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 | We only analyzed those who were referred to other mental health treatment, and for whom we were able to receive the information from their treatment program | Posted | Count of Participants | Participants | 30 days after discharge from the hospital |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Treatment as Usual (TAU) | Participants will have the typical treatment during and after their hospitalizations, without additional intervention. Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization. | 0 | 47 | 0 | 47 | 0 | 47 |
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