This is the protocol for a randomized controlled trial studying the efficacy of a novel e-RPT program. Participants (n=60) diagnosed with AUD will be recruited through physician referrals from Kingston Health Sciences Centre, family physicians, other health care providers, and self-referrals within 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 [35]. The MINI is a diagnostic interview that assesses 17 common mental disorders by following the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition [35]. After the MINI, the Readiness to Change Questionnaire (RCQ) will be administered in an interview format to investigate the individual's desire to change their alcohol consumption [33]. In addition to the RCQ, participants will be asked questions listed in Textbox 1 to capture their history with AUD. Answers to these questions, along with the intake MINI, will be reviewed with the principal investigator (PI) to ensure that the participant meets eligibility criteria and to confirm the AUD diagnosis.

Participant inclusion criteria are being 18 years or older at the start of the study and having a diagnosis of mild to moderate AUD according to the MINI (2 to 5 MINI AUD symptom criteria) [20], competence to consent and participation, ability to speak and read English, and consistent and reliable access to the internet. Additionally, contemplation about stopping or having stopped consuming alcohol in the past 30 days is required. This will be assessed by the RCQ (participants should be in the contemplation or action stage according to the questionnaire) and by asking them about when they stopped drinking or began considering alcohol cessation [34,35]. Exclusion criteria are acute hypomanic or manic episodes, acute psychosis, other active substance use disorders classified as moderate or severe, active suicidal or homicidal ideation, untreated clinically substantial somatic symptoms or mental disorders, or current enrollment in another relapse prevention program. Additionally, men who consumed more than 4 drinks per day or 14 drinks per week and women who drank 3 drinks per day or 7 drinks per week in the past month will be excluded [36].

Upon completion of the eligibility assessments, participants will be randomly assigned through a computerized system to one of the 2 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 (eg, medications, regular physician or clinician visits, referrals, or consultations that are conducted outside of this research study). The e-RPT program will be delivered through the Online Psychotherapy Tool (OPTT), a secure and interactive platform developed by the PI [37]. The face-to-face RPT program will be delivered through videoconference sessions using Microsoft Teams. Participants in the e-RPT and face-to-face groups will also have access to OPTT to access the triage module, the daily drinking diary (Figure 1), and assessment questionnaires.

The triage module is a short module intended to introduce clients to the RPT program and the drinking diary. All participants in the e-RPT and face-to-face groups will complete this module before starting their respective treatments.

Participants in the e-RPT group will receive 10 predesigned online modules per week on the OPTT platform. Each module consists of approximately 30 slides and should have an estimated completion time of 45 minutes. At the end of each module, participants will be assigned homework to be completed before their next module is assigned. The therapists will submit personalized feedback by using session-specific therapy feedback templates. These structured templates standardize the quality of feedback across different patients and therapists. In previous studies, therapists have been able to effectively use these templates to prepare feedback in approximately 15-20 minutes [30].

This e-RPT program will focus on teaching essential cognitive and behavioral 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 in Table 1.

Participants in the face-to-face intervention will meet with their therapist weekly through videoconferencing on Microsoft Teams [38]. During these 1-hour sessions, therapists will follow the same 10-week structure and content as e-RPT (Table 1). In contrast to e-RPT, where homework is written web-based by the therapist, the homework for the face-to-face sessions will be reviewed with the participant during the live session. At the end of each session, participants will receive the same homework and feedback as the e-RPT condition.

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 PI, who is an expert in the electronic delivery of psychotherapy [30,39,40]. During training, the PI will closely guide the therapists through their first patient (assigning modules, reviewing homework, writing feedback, and conducting face-to-face sessions). All therapists will be supervised by the PI to ensure the quality and reliability of the treatment programs. To ensure the quality of the feedback, therapists will practice writing it using structured templates. All face-to-face sessions and feedback will be reviewed with the PI before being sent to the participants.

The primary objective of this study will be to determine if e-RPT has similar effectiveness to face-to-face RPT at reducing alcohol consumption and preventing relapses. This study defines relapse as either the consumption of at least 2.5 oz. of pure ethanol, which is around 4 and a half standard drinks (Canadian guidelines for standard drinks: 12 oz of beer with 5% ethanol, 12 oz of cider with 5% ethanol, 5 oz of wine with 12% ethanol, and 1.5 oz of spirits with 40% ethanol) [41,42] on one occasion or hospitalization because of alcohol drinking [43]. Therefore, to determine the effectiveness of this program, daily alcohol consumption will be recorded in a drinking diary accessible through OPTT. This diary will ask the participants to report how many drinks they consumed on each day of the week, where they had those drinks, with whom, and if their alcohol consumption resulted in hospitalization (Figure 1).

The study will also determine whether e-RPT and face-to-face RPT have a beneficial effect on self-efficacy, quality of life, resiliency, coping behaviors, and depressive symptomatology. These metrics will be assessed through the following scales: Situational Confidence Questionnaire (SCQ-100) [44], 14-item Resilience Scale (RS-14) [45], Coping Behaviors Inventory (CBI) [46], Patient Health Questionnaire (PHQ-9) [47], and Quality of Life Enjoyment and Satisfaction Questionnaire—Short Form (Q-LES-Q-SF) [48]. These assessment scales will be completed at study entry (baseline), amid the program (week 5), and post treatment (week 10). After the treatment period, we will conduct follow-up assessments with all our outcome measures at 3, 6, and 12 months. The amount of time that e-RPT therapists spend writing feedback compared to the 1-hour face-to-face session will be used as a measure of therapists’ time efficiency and will be tracked on the OPTT platform.

All components of this study were reviewed for ethical compliance by the Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (File #: 6033212) in April 2022. Participants are only identifiable by an ID number, and all records are stored on a secure platform. Participant data is only accessible by the care providers, and anonymized data is provided to the analysis team. Participants can withdraw from the study at any point and request that their data be removed from the analysis. The research team will safeguard the privacy of the participants to the extent permitted by the applicable laws and their duty to report.

OPTT is compliant with the Health Insurance Portability and Accountability Act, Personal Information Protection and Electronic Documents Act, and Service Organization Control 2. 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.

The data will be initially assessed for outliers, missing, and 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 dropout rate of up to 40% for both conditions once the study concluded [49]. Thus, this study will intentionally oversample the experimental and control groups to account for this dropout rate. Considering the effect size for face-to-face RPT reported by Harada et al [50] (2021) for CBI (effect size=0.65), a significance level of α=.05 and a power of 0.90, a sample size of 60 (30 per arm) would be sufficient to detect substantial changes from our interventions [51]. As this is the first study aiming to establish an e-RPT program for AUD, this sample size calculation relies on data from face-to-face RPT and takes into account the established effectiveness of online psychotherapy compared to face-to-face psychotherapy [30].

The analysis will begin by examining the data for missing, nonsensical, and outlying variables. The data will then be analyzed on a per-protocol basis, excluding missing data, and with intention-to-treat analysis to assess the clinical effects of the program on participants who dropped out prematurely. All calculations will be done using a 2-tailed significance level of α=.05, except for when a Bonferroni correction is needed. The demographic information of program completers and program dropouts will be compared using independent sample t tests to identify possible differences. A 2 by 3 repeated measures ANOVA of the primary (daily drinking and relapse) and secondary (SCQ-100, Q-LES-Q-SF, RS-14, CBI, and PHQ-9) outcomes will be conducted to test for the effects of the interventions (e-RPT or face-to-face RPT) throughout the 10-week treatment (0, 5, and 10-week assessment points). Linear regression (for continuous outcomes) and binomial regression analysis (for categorical outcomes) will be used to identify variables associated with outcome measures. Additionally, OPTT will collect usage statistics (ie, number of logins per day, amount of time spent logged in) and compare them to face-to-face metrics (ie, attendance to weekly 1-hour face-to-face sessions) to determine cost and time savings between the 2 programs. All statistical analyses will be conducted using IBM SPSS Statistics for Mac (version 24; IBM Corp).