Developing and Implementing an Online Relapse Prevention Psychotherapy Program for Patients With Alcohol Use Disorder
Developing and Implementing an Online Relapse Prevention Psychotherapy Program for Patients With Alcohol Use Disorder
Alcohol use disorder (AUD) is characterized by problematic alcohol use accompanied by clinically significant distress. This disorder is associated with high relapse rates, with one in five patients remaining abstinent 12 months post-treatment. Traditional face-to-face relapse prevention treatment (RPT) is a form of cognitive behavioural therapy that examines one's situational triggers, maladaptive thought processes, self-efficacy, and motivation, however access to this treatment is frequently limited due to its high cost, long waitlists, and inaccessibility. Thus, an online adaptation of RPT (e-RPT) could address these limitations by providing a more cost-effective and accessible delivery method for mental health care in this population. This study aims to establish the first academic e-RPT program to address AUD in the general population. We will recruit adult participants (n = 60) with a confirmed diagnosis of AUD. Then, these participants will be randomly assigned to receive ten sessions of e-RPT or face-to-face RPT. e-RPT will consist of 10 predesigned modules and homework with asynchronous personalized feedback from a therapist. Face-to-face RPT will consist of 10, one-hour long face-to-face sessions with a therapist. The predesigned modules and the face-to-face sessions will present the same content and structure. Self-efficacy, resilience, depressive symptomatology, and alcohol consumption will be measured through various questionnaires at baseline, week 5, and week 10. Outcome data will be assessed using linear and binomial regression (continuous and categorical outcomes respectively). Qualitative data will be analyzed using thematic analysis methods.
Participants (n = 60) diagnosed with AUD will be recruited through physician referrals from Kingston Health Sciences Centre, family physicians, and other healthcare providers, and self-referrals in Kingston, Ontario. After providing consent to participate in the study, a Mini International Neuropsychiatric Interview 7.0.2 (MINI) will be conducted to confirm the diagnosis of mild to moderate AUD and other eligibility parameters (Sheehan et.al. 1981). The MINI is a diagnostic interview that assesses 17 common mental disorders by following the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnostic criteria (Sheehan et.al. 1981). After the MINI, the Readiness To Change Questionnaire (RCQ) will be administered in an interview format to understand the individual's desire to change their alcohol consumption (Rollnick et.al. 1992). In addition to the RCQ, participants will be asked the following questions to get a better understanding of their history of AUD: Have you been diagnosed with AUD?; If Applicable: When were you diagnosed with AUD?; Are you currently enrolled in another relapse prevention program?; In the past month how many times have you had an alcoholic beverage?; If applicable: in those times, on average how many drinks did you have?; If applicable: in the past month on average, how many drinks did you have per week? The intake MINI and questions will be reviewed with the head psychiatrist, to ensure that the participant meets eligibility criteria and to confirm the diagnosis of AUD.
Interventions Upon completion of the eligibility assessments, participants will be randomly assigned through a computerized system to one of two groups; e-RPT or face-to-face RPT. Participants will be equally stratified (e-RPT n = 30; face-to-face RPT n = 30). These treatments will be delivered as an augmentation to treatment as usual (TAU) (e.g., medications, regular physician or clinician visits, referrals or consultations that are conducted outside of the current research study). The e-RPT program will be delivered through the Online Psychotherapy Tool (OPTT; OPTT Inc.), a secure and interactive platform developed by the Queen's Online Psychotherapy Lab (QUOPL). The face-to-face RPT program will be delivered through video conference sessions using Microsoft Teams. However, it is important to note that participants in the face-to-face group will also have access to OPTT. Participants in both groups will need access to OPTT to complete module 0 before starting with their respective programs, and to access their drinking diary to report their daily drinking. Module 0 will only serve to quickly introduce participants to OPTT, and the programs and to access their drinking diary.
E-RPT
Participants in the e-RPT group will receive 10 weekly predesigned online modules. The content of this program will involve interactive therapy modules and homework, for which participants will receive asynchronous individualized feedback from a therapist each week. Participants in the e-RPT condition will receive one module per week and have continuous access to them on the OPTT platform. On average each module consists of 30 slides and should take approximately 45 minutes to complete. At the end of each module, participants will be assigned homework to be completed and submitted to their respective therapists up to 48 hours before their next weekly session. The therapists will develop personalized feedback by using session-specific therapy feedback templates. These templates ensure that feedback is also more standardized and structured between different patients and therapists. In previous studies, therapists have been able to effectively use these templates to prepare feedback in approximately 15-20 minutes. Therefore, compared to one-hour-long face-to-face therapy sessions, online sessions require around 15-20 minutes of therapist time, which can enhance the scalability of the online intervention and increase the number of individuals assigned to a therapist. Following the principles of CBT and RPT, this e-RPT program will focus on teaching essential cognitive and behavioural skills such as identifying maladaptive thought processes, increasing engagement in day-to-day activities, and developing strategies to reduce alcohol consumption. The content of the sessions is outlined below:
Face-to-Face RPT Participants in the face-to-face intervention will meet with their therapist weekly through Microsoft Teams (video conference). During these 1-hour sessions, therapists will follow the same 10-week structure and content as e-RPT. Though compared to e-RPT, in face-to-face sessions, the homework will be reviewed with the participant, during the session, providing the appropriate feedback. Then the therapists will prepare a weekly patient report of each session for the principal investigator. At the end of each session, participants will receive the same homework as the e-RPT condition which they will receive feedback on during the following face-to-face session. Following the 10-week face-to-face intervention, participants will have the opportunity to join the e-RPT program.
Training Therapists for both e-RPT and face-to-face RPT will consist of research assistants who are trained in RPT and writing feedback. All therapists are trained by the principal investigator, who is an expert in the electronic delivery of psychotherapy (Alavi and Hirji 2020, Alavi et.al. 2016, Alavi and Omrani 2018). During training, the principal investigator will closely guide the therapists through their first patient (assigning modules, reviewing homework, writing feedback, and conducting face-to-face sessions). Then through the study, the therapists will be supervised by the principal investigator to ensure the quality and reliability of the treatment programs. To ensure the quality of the feedback, therapists will practice by writing feedback on practice homework templates. All feedback will be examined and revised by the principal investigator before being sent to the participants.
Ethics and privacy All components of this study were approved by the Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (TRAQ: 6033212). Participants were only identifiable by an ID number and hard copies of consent forms were stored securely on-site and will be destroyed 5 years after study completion. Participant data was only accessible by the care providers and anonymized data was provided to the analysis team. Participants could withdraw from the study at any point and request for their data to be removed from the analysis. The research team will safeguard the privacy of the participants to the extent permitted by the applicable laws and duty to report. OPTT is Health Insurance Portability and Accountability Act, Personal Information Protection and Electronic Documents Act, and Service Organization Control - 2 compliant. All servers and databases are hosted in Amazon Web Service Canada cloud infrastructure to assure provincial and federal privacy and security regulations are met. OPTT does not collect identifiable personal information or IP addresses. OPTT collects anonymized metadata to improve service quality and provide advanced analytics to the clinician team.
Data Analysis At first, data will be assessed for outliers, missing, and/or nonsensical variables. These variables will not be imputed since they will be handled as missing. Similar studies that involved CBT and e-CBT demonstrated a drop-out rate of up to 40% for both conditions once the study concluded (Bados et.al. 2007). Thus, this study will intentionally over-sample the experimental and control groups to account for this drop-out rate. Given that several outcomes will be used, it is difficult to calculate a single sample size or provide a specific power calculation. However, applying the IMMPACT recommendations for treatment outcomes associated with pain and function, the minimal clinically important difference (MCID) for mood related outcomes is a change higher than 2 to 12 points in mood related scores from baseline (Dworkin et.al. 2008, Gatchel et.al. 2013). Thus, with a sample of 60 participants (30 per arm) and applying the sample size calculation presented by Rosner (2011) with p = 0.05 and a power of 0.95, our study would be able to significantly detect changes in mood scores of 3 to 12 points or higher (depending on the scale). Baseline mood scores related to AUD applied to the sample size calculation were obtained from the literature (O'Reilly et.al. 2019, Jordans et.al. 2019). Using Mann-Whitney-U tests, demographic information from individuals who completed the program and those who dropped out will be compared to identify possible differences. Additionally, an intention-to-treat analysis will be conducted to assess the clinical effects of the program on participants who dropped out prematurely. Linear regression (continuous outcomes) and binomial regression analysis (categorical outcomes) were used to identify variables associated with outcome measures. Comparative analysis between groups was analyzed using group and paired t-tests. OPTT collected usage statistics (i.e., number of logins per day, amount of time spent logged in) will be compared to face-to-face metrics to determine cost and time savings between the two programs.
Current progress According to the literature on the efficacy of CBT in AUD we hypothesize that both e-RPT and face-to-face RPT will reduce alcohol consumption, relapse(s) risk, and improve other outcome measures of interest (depressive symptom, self-efficacy, quality of life, and resilience) (Connor et.al. 2016). This randomized controlled trial was approved by the Queen's University Health Science and Affiliated Teaching Hospitals Research Ethics Board in April 2022 and began recruitment in October 2022. We expect to finalize recruitment and data gathering in October 2023 and analyze the findings by December 2023 at which point we will begin our process of knowledge dissemination (including but not limited to peer-reviewed publications, scientific presentations, grant proposals, and reports).
Inclusion Criteria:
Exclusion Criteria: