Online Relapse Prevention Therapy for Patients With Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

Developing and Implementing an Online Relapse Prevention Psychotherapy Program for Patients With Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579210
• Other study ID #: 6033212
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: April 23, 2024

Study information

• Verified date: April 2024
• Source: Queen's University
• Contact: Gilmar S Gutierrez, MD
• Phone: 6048095012
• Email: gilmar.gutierrez[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

• 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 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 a 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 cravings 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 23, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Diagnosis of mild to moderate AUD according to the DSM-5

• Competence to consent to participate in the study

• Ability to speak and read English

• Consistent and reliable access to the internet

• In contemplation stage of change (according to Readiness for change questionnaire) related to stopping drinking or having stopped consuming alcohol in the past 30 days

Exclusion Criteria:

• Acute hypomanic/manic episodes

• Acute psychosis

• Active substance use disorder classified as moderate or severe according to the DSM-5

• Active suicidal or homicidal ideation

• Untreated clinically significant somatic symptoms or mental disorders (PHQ = 15, GAD-7 = 15)

• Current enrolment in another relapse prevention program

• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Online relapse prevention therapy
Participants in the e-RPT group will receive 10 weekly predesigned online modules. The content of this program will involve interactive therapy modules based on the principles of. 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. The contents of each session are outlined on the detailed description section.
• Face to face relapse prevention therapy
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.

Locations

Country	Name	City	State
Canada	Queen's University Online Psychotherapy lab	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Nazanin Alavi

Country where clinical trial is conducted

Canada, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative assessment of treatment engagement through the program, by looking at module completion, and adherence to the program	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.	Once a week for the 10 weeks of the program
Primary	Change in daily drinking using a Drink diary	Records daily drinking in standard drinks, setting of drinks, if participant drank with someone else, and if the drinking resulted in hospitalization that day.	Daily records in drinking diary from baseline (week 0) to study endpoint (10 weeks)
Secondary	Self-efficacy at resisting craving or urges to engage in addictive behaviour using the Situational Confidence Questionnaire (SCQ-100)	Self-efficacy will be measured through the Situational Confidence Questionnaire (SCQ-100) which is a self-report that consists of 100 items and 8 subscales [42]. The SCQ-100 examines experiences that people with AUD have concerning relapse or excessive drinking [42].	Baseline (pre treatment), week 5 (mid treatment), week 10 (post treatment)
Secondary	Quality of life changes from baseline using the Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form (Q-LES-Q-SF)	Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form (Q-LES-Q-SF) [43]. This 16-item self-reported questionnaire explores topics related to health including a participant's leisure activities, medication satisfaction, mood, and physical health [43]. A five-point scale is used to assess different aspects of an individual's life. A score of 1 indicates that the specific part of the person's life is very poor and a score of 5 indicates that it is very good [43]	Baseline (pre treatment), week 5 (mid treatment), week 10 (post treatment)
Secondary	Resilience changes from baseline using the 14-item Resilience Scale (RS-14)	The 14-item Resilience Scale (RS-14) will be used to measure resilience [45]. The RS-14 presents 14 statements to the participant with responses ranging from 1 meaning they strongly disagree with the statement to 7 indicating that they strongly agree with the statement [45].	Baseline (pre treatment), week 5 (mid treatment), week 10 (post treatment)
Secondary	Coping behaviours and thoughts changes from baseline using the Coping Behaviors Inventory (CBI)	Behaviours and thoughts that can aid in preventing, avoiding, and controlling the resumption of heavy drinking will be measured through the Coping Behaviors Inventory (CBI) [47]. The CBI is a 36-item self-report questionnaire with two subscales of 14 cognitive and 22 behavioural questions [47]. This scale assesses various thoughts and behaviours that a person with AUD might use to decrease or avoid alcohol consumption [47].	Baseline (pre treatment), week 5 (mid treatment), week 10 (post treatment)
Secondary	Depressive Symptomatology changes from baseline using the Patient Health Questionnaire (PHQ-9)	Depressive Symptomatology will be measured through the Patient Health Questionnaire (PHQ-9) [48]. This 9-item self-report questionnaire assesses a participant's depressive symptomatology in the last two weeks [48]. Answers are measured on a scale of 0 meaning, not at all to 3 indicating that the person experiences the statement nearly every day [48]	Baseline (pre treatment), week 5 (mid treatment), week 10 (post treatment)
Secondary	Efficiency of therapist's time comparing time spent writing personalized feedback to time spent conducting the face-to-face sessions	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.	Once a week for the 10 weeks of the program