Developing and Implementing an Online Relapse Prevention Psychotherapy Program for Patients With Alcohol Use Disorder
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: Dr. Nazanin Alavi

Protocol: Developing and Implementing an Online Relapse Prevention Psychotherapy 
Program for Patients with Alcohol Use Disorder 
 
Introduction 
Background and Rationale 
Alcohol use disorder (AUD) is a mental health disorder that affects approximately 3.6% of the 
global population aged 15 to 64 (Rehm et.al. 2009). The disorder is highly prevalent and a major 
contributor to illness and mortality worldwide (Grant et.al. 2004, Kranzler et.al. 2018). AUD is 
characterized by impaired control over alcohol use leading to physiological dependence and 
negative psychological, social, and physical consequences (Kranzler et.al. 2018, Castillo-Carniglia 
et.al. 2019). The disorder is associated with many physical and psychiatric comorbidities such as 
major depressive disorder, generalized anxiety disorder, liver cancer, and hypertension (Grant 
et.al. 2004, Rehm 2011, Samokhvalov et.al. 2010, World Health Organization 2001).  
 
Additionally, the rise in mental health challenges during the COVID-19 pandemic resulted in 
growing concerns over the health behaviours of individuals with AUD (Drinking alone, 2020). 
Stay-at-home orders presented complex relationships between financial issues, low social 
interaction, and anxiety about the future (Da et.al. 2020). Moreover, the disruption to clinical 
services likely contributed to increased relapse and subsequent negative health outcomes for 
people with AUD (Clay and Parker 2020). Kim et.al. (2020) demonstrated that out of 182 
participants with previous hazardous AUD, 23% increased their consumption during lockdown. 
Additionally, 17% of the subjects were abstinent for an average of 19.5 months before relapsing 
during lockdown (Kim et.al. 2020).  
 
AUD treatments typically involve practicing abstinence from alcohol, due to the high failure rates 
and risks associated with a controlled drinking approach (Barrick and Connors 2002, Glan 1995). 
However, alcoholism is known as a “relapsing condition”, since patients often relapse following 
abstinence (Chick 1981). Within the AUD framework, a lapse is defined as a single episode of 
drinking, whereas a relapse involves a return to a pattern of problematic drinking (Da et.al. 2020). 
Hunt et.al. (1971) found that approximately three months after AUD treatment, there was a 35% 
to 58% relapse rate. Thus, an effective AUD management program should focus on relapse 
prevention. This could be achieved through the identification of personal factors increasing the 
likelihood of a relapse and the development of strategies to decrease the rates and severity of 
relapses.  
 
Psychosocial interventions are commonly used to treat AUD, with cognitive behavioral therapy 
(CBT) being one of the most studied psychological approaches (Pearson et.al. 2012, Miller et.al. 
2002). CBT for AUD focuses on teaching coping skills to encourage abstinence in the presence of 
triggers and cravings, by targeting maladaptive thought processes and behaviors. (Carroll et.al. 
2017, Monti 2002). This therapeutic approach has demonstrated greater efficacy compared to no 
treatment and minimal treatment (Magill et.al. 2019). Relapse prevention therapy (RPT) is a form 
of CBT and is a validated treatment for AUD (Carroll 1996, Irvin et.al. 1999, McCrady 2000), that 
focuses on relapse prevention by targeting both interpersonal and intrapersonal factors, motivation, 
and triggers identification. Thus, through this therapy, patients can develop important coping 

Protocol: Developing and Implementing an Online Relapse Prevention Psychotherapy 
Program for Patients with Alcohol Use Disorder 
 
strategies to apply in situations where alcohol may be available, to prevent a relapse (Heather et.al. 
2004).  
 
Nevertheless, despite CBT’s effectiveness, financial issues, accessibility, and logistical problems 
may make it challenging for individuals to receive care face-to-face (Irvin et.al. 1999). Moreover, 
individuals with AUD frequently experience shame and stigma surrounding their diagnosis which 
can reduce treatment seeking in this population (Probst et.al. 2015). Previous research has also 
demonstrated that stress associated with entering AUD treatment can increase alcohol cravings 
and the risk of relapsing (Sinha 2007). Therefore, online delivery of CBT (e-CBT) in the form of 
RPT (e-RPT) may address these barriers to care. 
 
Online psychotherapy, such as eCBT has flourished in recent years, due to its accessibility and 
affordability for the patient and clinician (e.g. not requiring office space, lower demands on 
therapists’ time, accessible at any time and from anywhere with internet connection, etc.). 
Furthermore, some studies have demonstrated that e-CBT is just as effective as in-person CBT for 
the management of AUD (Johansson et.al. 2020). e-CBT commonly follows the same structure as 
in-person CBT sessions. and consists of predesigned online modules and homework with 
asynchronous personalized therapist’s feedback. However, despite these benefits, research 
studying that examines the effectiveness of e-CBT and e-RPT is limited. Hence, more research is 
needed to supplement this gap and the development of accessible, and cost-effective online 
psychotherapy programs for this population (Andersson and Titov 2014). 
 
Therefore, offering asynchronous online therapy modules teaching e-RPT, can be a viable solution 
to address the potential accessibility, stigma, and financial issues presented by traditional in-person 
therapies (Andersson and Titov 2014). This study aims to examine the effectiveness of e-RPT at 
reducing alcohol consumption and preventing relapse. Also, additional impacts of this therapy will 
be studied by assessing quality of life, resilience, depressive symptomatology, and self-efficacy. 
The results of this study should supplement the available literature and aid in the establishment of 
a novel e-RPT program for the management of AUD. Also, it will inform clinical practice about 
the use of e-RPT to increase accessibility to this type of care.  
Objectives 
The primary objective of this study is to determine the effectiveness of a secure online e-RPT 
treatment for AUD at decreasing relapse rates, in comparison to face-to-face RPT. Based on the 
evidence comparing face-to-face and online psychotherapies, we hypothesize that both face-to-
face RPT and e-RPT will have similar effectiveness in the management of symptoms of AUD – 
decreasing alcohol consumption and lowering relapse rates. The secondary objective involves 
determining whether using e-RPT results in beneficial effects to quality of life, self-efficacy, 
resilience, and depressive symptomatology. The tertiary objective involves determining whether 
the use of e-RPT results in better therapists’ time efficiency, by tracking the amount of time that a 
therapist spends with each patient in e-RPT compared to face-to-face RPT 
Methods 

Protocol: Developing and Implementing an Online Relapse Prevention Psychotherapy 
Program for Patients with Alcohol Use Disorder 
 
 
Participants 
Participants (n = 60) diagnosed with AUD will be recruited through physician referrals from 
Kingston Health Sciences Centre, family physicians, and other healthcare providers, and through 
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. 
 
Participant inclusion criteria include being 18 to 64 years of age at the start of the study and having 
a diagnosis of mild to moderate AUD according to the DSM-5 (AUDIT score > or = to 8 for males 
and 7 for females and below 19 for both) (Carroll et.al. 2017). Competence to consent and 
participate, 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 (Cougle et.al. 2017, Witkiewitz et.al. 2019). Exclusion 
criteria are acute hypomanic/manic episodes, acute psychosis, active substance use disorder 
classified as moderate or severe, active suicidal or homicidal ideation, untreated clinically 
significant somatic symptoms or mental disorders (PHQ ≥ 15, GAD-7 ≥ 15), and/or current 
enrollment in another relapse prevention program. Additionally, men who drink more than four 
drinks per day or 14 drinks per week and women who drink three drinks per day or seven drinks 
per week in the past month will be excluded (Dawson et.al. 2005). This exclusion criteria is 
intended to minimize the risk that a participant will experience withdrawal symptoms while going 
through the program.  
 
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, 

Protocol: Developing and Implementing an Online Relapse Prevention Psychotherapy 
Program for Patients with Alcohol Use Disorder 
 
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. 
Though, 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, 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 
increases 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: 
 
Session 1: Understanding Addiction – Introduces relapse prevention and what to expect from the 
course. The session explains what addiction is, including symptoms, signs, consequences, and the 
different types of addiction. Participants will create a SMART goal that they will try to achieve 
throughout the weeks. They will also share their personal experience with addiction 
 
Session 2: Exploring and Strengthening Your Motivation – Focuses on the five stages of 
motivation and the role of motivation in relapse prevention. Helpful techniques are discussed to 
reflect on and boost motivation throughout their recovery journey. Participants will create a pros 
and cons list about stopping alcohol use and will reflect on different aspects of their ability to stop 
using alcohol. 
 
Session 3: Triggers – Describes what triggers are and how to recognize them, including both 
internal and external triggers. This session also provides strategies for how to handle triggers 

Protocol: Developing and Implementing an Online Relapse Prevention Psychotherapy 
Program for Patients with Alcohol Use Disorder 
 
through avoidance and careful planning. Participants will be asked to identify their triggers and 
how to prepare for them if encountered.  
 
Session 4: Handling Cravings and Signs of Relapse – Presents skills to use when confronting 
cravings, and how to identify and prevent a potential relapse. For instance, by applying distraction 
methods when they experience stressful situations to decrease their urge to consume alcohol. Also, 
it asks participants to identify their warning signs by reflecting on previous relapse experiences.  
 
Session 5: The 5 Part Model – Provides further introduction about CBT and its components. Also, 
it explains the 5 Part Model, which highlights the importance of differentiating between our 
thoughts, feelings, physical reactions, and behaviours in stressful situations. Participants are asked 
to complete the 5 Part Model with an example from their life.  
 
Session 6: The Thought Record - Part 1 – Introduces the thought record and its relation to CBT 
to help in the understanding of the connection between feelings, behaviours, and thoughts. This 
session focuses on the first three columns of the Thought Record (out of 7 columns). The first 
three columns include the situation, followed by the feelings and automatic thoughts associated 
with the situation. Participants are asked to complete the first three columns of a thought record 
for at stressful situation they experienced within the past week.  
 
Session 7: The Thought Record - Part 2 – This session continues with the remaining 4 columns 
of the Thought Record including, gathering evidence in support and against the identified 
automatic thoughts, and finding alternative and balanced thoughts after examining the evidence. 
Thus, this session highlights how to challenge irrational thoughts by developing more balanced 
and helpful thoughts. Participants have to complete a full thought record from a stressful 
situation related to their AUD within the past week.  
 
Session 8: Thinking Errors and The Activity Record – Explores irrational thinking and common 
thinking errors. This session also presents and highlights the importance of the Activity Record; 
a tool designed to record and plan weekly activities. Participants are asked to complete an 
activity record for an entire week.  
 
Session 9. Mindfulness and Breathing Techniques – Presents mindfulness, breathing techniques, 
and other helpful skills to reduce urges and craving associated with alcohol and to promote 
increased awareness. Participants are asked to incorporate one or more of these practices into 
their daily routines for a week and to reflect on how these practices made them feel. Also, to 
reflect on which practice, if any, they found to be the most effective.  
 
Session 10. Review - This session is a review of the program. It summarizes all the useful tools 
and techniques for relapse prevention learned throughout the program. Participants are asked to 
reflect on the activities that they found to be the most effective throughout the sessions.  
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 

Protocol: Developing and Implementing an Online Relapse Prevention Psychotherapy 
Program for Patients with Alcohol Use Disorder 
 
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.  
 
Outcome measures  
The primary objective of this study will be to determine if e-RPT has similar effectiveness as face-
to-face RPT at reducing alcohol consumption and preventing relapses. The current study defines 
relapse as either the consumption of at least 60g of pure ethanol (approximately four and a half 
standard drinks (Baltieri et.al. 2008)) per occasion or hospitalization because of alcohol drinking 
(Baltieri et.al. 2008). 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 had on each day of the week, where they had those 
drinks and with whom. Also, this diary will ask if the participant was hospitalized as a result of 
alcohol consumption.  
 
As a secondary objective this study will determine whether e-RPT and face-to-face RPT had a 
beneficial effect on self-efficacy, quality of life, resiliency, coping behaviors and depression 
symptomatology. These metrics will be assessed by using the following scales SCQ (Miller et.al. 
1989), Q-LES-Q-SF (Endicott et.al. 1993), RS-14 (Aiena et.al. 2015), CBI (Litman et.al. 1983), 
and PHQ-9 (Löwe et.al. 2004) respectively. These assessment scales will be completed at study 
entry (baseline), mid-program (week 5), and post-treatment (week 10). Other behavioural data 
regarding patients’ interaction and engagement with their therapy such as module and homework 
completion in e-RPT, and session attendance in face-to-face RPT will be collected to provide 
qualitative information about these programs. Finally, the tertiary objective involves determining 
whether using e-RPT is more time efficient than face-to-face RPT. Thus, this study will track the 
amount of time that e-RPT therapists spend writing feedback compared to the one-hour face-to-
face session as a measure of therapists’ time efficiency.  
 
Ethics and privacy: 

Protocol: Developing and Implementing an Online Relapse Prevention Psychotherapy 
Program for Patients with Alcohol Use Disorder 
 
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 

Protocol: Developing and Implementing an Online Relapse Prevention Psychotherapy 
Program for Patients with Alcohol Use Disorder 
 
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). 
 
 
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