Treatment Engagement With Technology-assisted Treatment
Phase: NA
Conditions: Alcoholism, Substance-related Disorders, Mentally Ill Chemical Abuse, Educational Technology
Sponsor: Johns Hopkins University

 
 
Date: 4/14/16 
Principal Investigator: Eric C. Strain, MD 
Application Number: IRB0007923 
NCT: 02674477 
Title: Treatment Engagement With Technology-assisted Treatment 

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1. 
Abstract 
 
Technology-assisted treatment, or TAT (e.g., online modules, mobile applications), shows 
promise for innovative assessment, prevention, and treatment of substance use disorders (SUDs).  
The widespread access to TAT makes it a potentially cost-effective and innovative option 
available for delivery in multiple settings. To date, there have been no published studies that 
investigate whether TAT is effective in patients with SUDs in addition to another psychiatric 
illness (dual diagnosis patients). Thus, we plan to pilot a computerized cognitive behavioral 
therapy (CBT) program called the Therapeutic Education System (TES) in dually diagnosed 
inpatients and allow them access to the program as outpatients as well. Our hypothesis is that 
those assigned to TES will have better program retention and outpatient attendance than those 
assigned to treatment as usual (TAU), because the patients using TES may be more engaged in 
the process of problem recognition and problem solving with regard to their mental health and 
substance use problems. This research will be valuable to better understand the treatment needs 
of this dually diagnosed population, including ways to keep them engaged in care.  
 
2. 
Objectives  
We propose to conduct a controlled study assessing: 1) whether exposure to TES during 
hospitalization is acceptable to dually-diagnosed patients, and 2) whether TES use affects post-
discharge treatment retention. 
 
3. 
Background  
Several computerized contingency management and cognitive-behavioral interventions for SUDs 
have shown efficacy in single-site clinical trials, and TES has been shown to have efficacy in a clinical 
trial involving multiple community-based addiction treatment programs1-4. We surveyed inpatients 
on two hospital-based dual diagnosis units at the Johns Hopkins Hospital (JHH) to assess their interest 
in, access to, and experience with TAT, as well as preferences for content and implementation. 
Preliminary data suggest that despite most patients having no previous TAT exposure, they would 
welcome TAT during and after hospitalization, and would consider it helpful. Some patients preferred 
face-to-face therapy alone, suggesting that TAT should not completely replace these services. 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
 
This project will be conducted on the Motivated Behaviors Unit (MBU), which is an inpatient 
dual diagnosis treatment service located on Meyer 3. Standard MBU 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.  
 
Informed consent will be obtained from each potential participant. This process will include 
permission to contact participants following discharge, and to review their hospital chart for 
necessary information such as demographics and diagnoses. Volunteers will then undergo a 
baseline assessment on acceptability of TAT, using an instrument developed for this project, as 
well as an assessment of self-efficacy and health-related quality of life using the NIH Toolbox 
Self-Efficacy Survey5, and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-
36),6 respectively. Study participants will be randomized using an urn design method to receive 
either TAU or TAU plus TES. Patients will be stratified based on ethnicity, gender and whether 

 
 
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the primary drug of use is an opioid. Patients in the TES group will be taught how to use the web-
based therapy while inpatient and provided access to the system while residing on Meyer 3 using 
a participant-specific username and password. Each person’s account will be logged out at the 
end of their session on Meyer 3, and the laptops will not be used by other (non-study) patients, 
ensuring confidentiality. Participants will be encouraged to continue using the TES program after 
discharge by accessing the website with their login information. A reminder will be sent to them 
regularly via email or text message regarding their access to the program. They will be advised to 
log out after every session and close their browser, but to be aware that if someone were to track 
the history of the Internet browser, the HealthSim website would appear. Patients will be given a 
list of places available to use a computer for free, such as patient resource centers at JHH and the 
University of Maryland Hospital, as well as public libraries. The study team will have separate, 
password-protected access to user data within the TES program, though any patient identifiers 
will be kept separate from the program. HealthSim keeps user data confidential, and uses data at 
the minimum required for maintenance and support of the program’s use by each site. Per 
HealthSim, “any such use, however, shall be conducted in accordance with all applicable law and 
regulations, including privacy regulations.” 
 
The TES program consists of a series of 65 interactive modules on substance use-related topics 
(e.g., effective problem solving; HIV and AIDS; drug refusal skills training). We expect it will 
take less than thirty minutes to complete each module. Patients will be able to access the program 
during 1-hour long sessions, as often as possible. We anticipate TES usage will amount to at least 
2 hours per week. The assessment of TAT acceptability, self-efficacy and health-related quality 
of life will be re-administered prior to inpatient discharge, and then during follow up (as described 
below).   
 
Many patients discharged from the MBU receive referral appointments to the Community 
Psychiatry Programs (CPPs) at JHH or Johns Hopkins Bayview Medical Center (JHBMC) for 
psychiatric care, and many also go to the Broadway Center (the primary outpatient site operated 
by JHH for substance use treatment). When possible and appropriate, these will be the preferred 
referral sites for study participants, as is current practice. Patient involvement with outpatient care 
(i.e. enrollment) at either CPP can be tracked via the Electronic Medical Record. We will also 
track patient retention at other mental health and substance use treatment programs that patients 
may be referred to, by contacting the program directly with the patient’s consent.  
 
b. Study duration and number of study visits required of research participants. 
 
At the time of study enrollment and prior to discharge from the hospital, patients in both groups 
will be administered a survey that assesses acceptability of their inpatient and outpatient 
treatment, self-efficacy and health-related quality of life, drug and/or alcohol relapse, and the 
experimental group will also be assessed for their acceptability of TES.  
 
Since the length of inpatient stay and other factors may vary across patients, we will not attempt 
to dictate the number of TES modules that should be completed but will attempt to ensure that all 
TES participants have experience with the program before they leave and will track and record 
the amount of usage during the inpatient stay.  
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Blinding is not possible as those getting the intervention will be using the computer program 
whereas those that are in the control group will not. 

 
 
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d. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
 
All patients will receive treatment as usual, so no routine care will be stopped. 
 
e. Justification for inclusion of a placebo or non-treatment group. 
 
The TAU group will not receive the TES intervention, though they will still receive the typical 
treatment on the unit. A comparison of the survey responses and post-discharge program 
adherence of the TES and TAU groups will provide information as to whether the TES 
intervention is helpful. 
 
f. Definition of treatment failure or participant removal criteria. 
 
Participants will not be removed for treatment failure, as part of our goal is to investigate whether 
the TES program is easy to use by, and interesting to patients as part of the acceptability survey 
and review of module completion. Participants will be removed from the study if they no longer 
meet the inclusion criteria. For example, if a patient’s status changes to involuntary they will be 
removed from further participation, but any data gathered up until that point will be used in 
analysis. 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
Participants in the TES group will no longer have access to the computer-based program after the 
study ends, or if their participation ends prematurely, but all patients will receive standard 
inpatient care and referral to post-discharge treatment. 
 
5. 
Inclusion/Exclusion Criteria 
 
Potential participants will be patients voluntarily admitted to the JHH Motivated Behaviors Unit 
(MBU), whose patients primarily present from the East Baltimore community. Eligibility criteria 
include self-report of drug or alcohol use in the 30 days prior to admission, diagnosis of both a 
substance use disorder and other psychiatric illness, a proficiency in English, and an ability to provide 
informed consent. Patients who are actively psychotic, or cognitively impaired with a Mini-Mental 
State Examination (MMSE) score of 25 or less will be excluded. After listening to a recording of the 
content of the informed consent form, participants must be able to obtain a score of 100% on a consent 
quiz after up to 3 attempts, with a chance for remediation between attempts. We will consent 150 
participants with a plan to accrue about 130 persons in order to allow for drop outs or other early 
removals from the study and have a total of at least 100 participants. Our screening process will 
involve a study team member using the electronic medical record to ensure that the patient does 
indeed meet criteria for inclusion. The potential participant must be willing to participate and agree 
to the procedures in the consent form, such as allowing the team to contact his/her post-discharge 
provider(s). The person should also be willing to complete the risk assessment module through the 
TES program and at least one other TES module if randomized to that treatment arm, and to seek 
post-discharge treatment. Patients must have an email address, and if they do not have one they will 
be assisted in setting up an email account for distribution of surveys post-discharge. If a person does 
not set up an email account, surveys can be administered by phone post-discharge. The preferred 
method of payment for participant incentives will be Bank of America prepaid debit cards, so that 

 
 
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funds can be electronically deposited after they are discharged from the hospital. Participants will be 
required to sign an agreement regarding use of these cards. If necessary in certain cases, participants 
may receive other physical or electronic gift cards. 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 
As noted above, TES has shown efficacy in clinical trials among patients with SUDs in 
community-based addiction treatment programs. The two-group randomized design with TAU as 
the comparison condition was selected to provide a clinically relevant evaluation of TES when 
used as a supplement to TAU.  Since acceptability and effects on post-discharge follow up care 
are of primary interest in this pilot trial rather than mental health or drug use outcomes, any 
imbalance in amount of therapy delivered should not be relevant.    
 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. 
 
N/A 
 
 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
The Therapeutic Education System (TES) is not a physical/mechanical device; but it is a software 
program that is accessed through the Internet on any PC or Mac computer using a specific 
username and password. Our research subjects will use it through a site-specific license, so that 
their information is separate from other TES users. TES does not pose any significant risk to 
subjects as it is not an implant, is not used for sustaining human life, does not present potential 
for serious risk to the health, safety or welfare of a subject and will not be used substantially in 
diagnosing, curing, or mitigating disease. It is a treatment, but it is not the primary treatment 
modality that will be employed with patients who enroll in this pilot study. As therapy, it will 
only be used adjunctively to treatment as usual in the form of education, in a supervised manner. 
Thus, TES does not meet the definition for a significant risk device, but is a nonsignificant risk 
device. 
 
7. 
Study Statistics 
a. Primary outcome variable. 
Acceptability of TES, via both self-report and actual usage, will constitute the primary outcome 
measure for the randomized design portion of the study. 
 
b. Secondary outcome variables. 
The enrollment rate for outpatient mental health and substance abuse treatment at 30 days post-
discharge, and patient satisfaction regarding the hospital stay among both groups will be 
investigated as secondary outcomes. 
 
c. Statistical plan including sample size justification and interim data analysis. 
TES acceptability will be rated on a scale of 0-10, and will be analyzed by mean and SEM. 
Comparison of hospital ratings will be performed using a paired t-test. The hypothesis is that the 
TES group will have significantly higher ratings than the TAU group. Based on a previous study 
of acceptability of TES compared to standard treatment7, a power analysis with alpha = 0.05 

 
 
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indicates that 50 persons per group is adequate to demonstrate an effect size of 0.313, where 
estimated power is 0.87. 
 
d. Early stopping rules. 
Those patients who leave against medical advice without a follow up appointment will be 
excluded from further participation in the study and thus can be included in analysis of any 
surveys completed during their stay, but not the post-discharge surveys. Any participants who 
no longer meet inclusion/exclusion criteria (e.g. MMSE score falls to 25 or below) will be 
removed from the study. 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
N/A 
b. Steps taken to minimize the risks. 
N/A 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
These will be reported promptly to the IRB if any arise, though this is unexpected. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
Given the content of the questionnaires there is little anticipated legal risk.  
 
e. Financial risks to the participants. 
 
N/A 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
The participants in the TES group will benefit from participating in this study through 
increasing the skill set needed to work in recovery. Patients such as those participating in this 
study who have a substance use disorder as well as another psychiatric illness will benefit 
from the findings of this study as it will help us to better understand the needs of this 
population and whether this treatment will help them to be more engaged in their recovery. 
Similarly, this research will help the field and society through advancing what is currently 
known about psychiatric services for treating dually diagnosed patients, and thus working to 
reduce the mental and physical health complications, financial burden and disability caused 
by addiction in the community. 
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol. 
 
Each participant will be given a $10 Bank of America prepaid debit card or gift card for 
completing the initial survey at the time of study enrollment, and $10 for each completed 
study survey. Each participant will have the opportunity to earn up to $50 if all surveys are 
completed. 
 

 
 
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11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
There are no costs to patients who enroll in this study. Costs associated with the computer-
based treatment provided, and the incentives for this study, are not the responsibility of the 
patient, but are funded through a K award (Dr. Eric C. Strain, PI), and a scholarship received 
by Dr. Alexis Hammond. 

 
 
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