Alcoholism, Educational Technology, Mentally Ill Chemical Abuse, Substance-related Disorders
Conditions
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.
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.
OTHERTreatment 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.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Treatment Based on Survey Questionnaire Completed by Participants | 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. |
Secondary
| Measure | 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 | 30 days after discharge from the hospital |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 48 |
| 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. | 47 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 8 | 2 |
Baseline characteristics
| Characteristic | Therapeutic Education System (TES) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 47 Participants | 95 Participants |
| Age, Continuous | 38.5 years STANDARD_DEVIATION 10.4 | 39.8 years STANDARD_DEVIATION 8.1 | 39.01 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 44 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 18 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 27 Participants | 59 Participants |
| Region of Enrollment United States | 48 Participants | 47 Participants | 95 Participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 33 Participants | 31 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 47 |
| other Total, other adverse events | 0 / 48 | 0 / 47 |
| serious Total, serious adverse events | 0 / 48 | 0 / 47 |
Outcome results
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.
Time frame: prior to discharge from the hospital up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapeutic Education System (TES) | Acceptability of Treatment Based on Survey Questionnaire Completed by Participants | 8.78 score on a scale | Standard Error 0.2 |
| Treatment as Usual (TAU) | Acceptability of Treatment Based on Survey Questionnaire Completed by Participants | 8.23 score on a scale | Standard Error 0.3 |
Secondary
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
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Therapeutic Education System (TES) | Number of Participants Enrolled in Post-discharge Substance Abuse Treatment Appointments 30 Days After Hospital Discharge | 23 Participants |
| Treatment as Usual (TAU) | Number of Participants Enrolled in Post-discharge Substance Abuse Treatment Appointments 30 Days After Hospital Discharge | 19 Participants |
Secondary
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
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Therapeutic Education System (TES) | Number of Participants Enrolled in Post-discharge Treatment for Other Mental Health Appointments 30 Days After Hospital Discharge | 18 Participants |
| Treatment as Usual (TAU) | Number of Participants Enrolled in Post-discharge Treatment for Other Mental Health Appointments 30 Days After Hospital Discharge | 22 Participants |