An interventional study of Therapeutic Education System (TES) and Treatment as Usual (TAU) in Alcoholism, Substance-related Disorders and Mentally Ill Chemical Abuse, sponsored by Johns Hopkins University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-22.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 95 is close to the median of 88 across 1,395 interventional studies indexed under Alcoholism.
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Exclusion Criteria:
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)
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)
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.
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.
Time frame: prior to discharge from the hospital up to 30 days
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
| Milestone | Therapeutic Education System (TES) | Treatment as Usual (TAU) |
|---|---|---|
| Started | 48 | 47 |
| Completed | 40 | 45 |
| Not completed | 8 | 2 |
| Withdrew: Protocol violation | 8 | 2 |
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.
| score on a scale | Therapeutic Education System (TES) | Treatment as Usual (TAU) |
|---|---|---|
| Acceptability of Treatment Based on Survey Questionnaire Completed by Participants | 8.78 ± 0.2 | 8.23 ± 0.3 |
| Participants | Therapeutic Education System (TES) | Treatment as Usual (TAU) |
|---|---|---|
| Number of Participants Enrolled in Post-discharge Substance Abuse Treatment Appointments 30 Days After Hospital Discharge | 23 | 19 |
| Participants | Therapeutic Education System (TES) | Treatment as Usual (TAU) |
|---|---|---|
| Number of Participants Enrolled in Post-discharge Treatment for Other Mental Health Appointments 30 Days After Hospital Discharge | 18 | 22 |
Collected over 3 months after discharge from the hospital. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Therapeutic Education System (TES) | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Treatment as Usual (TAU) | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Age, Categorical(Participants) | Therapeutic Education System (TES) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 48 | 47 | 95 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Therapeutic Education System (TES) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Mean | 38.5 ± 10.4 | 39.8 ± 8.1 | 39.01 ± 9.3 |
| Sex: Female, Male(Participants) | Therapeutic Education System (TES) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Female | 15 | 16 | 31 |
| Male | 33 | 31 | 64 |
| Ethnicity (NIH/OMB)(Participants) | Therapeutic Education System (TES) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 3 |
| Not Hispanic or Latino | 48 | 44 | 92 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Therapeutic Education System (TES) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 16 | 18 | 34 |
| White | 32 | 27 | 59 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Therapeutic Education System (TES) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| United States | 48 | 47 | 95 |
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