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临床试验/NCT05579210
NCT05579210已完成不适用

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

Dr. Nazanin Alavi2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Change in daily drinking using a Drink diary

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in daily drinking using a Drink diary

时间窗: Daily records in drinking diary from baseline (week 0) to study endpoint (10 weeks)

Records daily drinking in standard drinks, setting of drinks, if participant drank with someone else, and if the drinking resulted in hospitalization that day.

次要结局

  • Quality of life changes from baseline using the Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form (Q-LES-Q-SF)(Baseline (pre treatment), week 5 (mid treatment), week 10 (post treatment))
  • Coping behaviours and thoughts changes from baseline using the Coping Behaviors Inventory (CBI)(Baseline (pre treatment), week 5 (mid treatment), week 10 (post treatment))
  • Self-efficacy at resisting craving or urges to engage in addictive behaviour using the Situational Confidence Questionnaire (SCQ-100)(Baseline (pre treatment), week 5 (mid treatment), week 10 (post treatment))
  • Resilience changes from baseline using the 14-item Resilience Scale (RS-14)(Baseline (pre treatment), week 5 (mid treatment), week 10 (post treatment))
  • Efficiency of therapist's time comparing time spent writing personalized feedback to time spent conducting the face-to-face sessions(Once a week for the 10 weeks of the program)
  • Depressive Symptomatology changes from baseline using the Patient Health Questionnaire (PHQ-9)(Baseline (pre treatment), week 5 (mid treatment), week 10 (post treatment))

研究者

发起方
Dr. Nazanin Alavi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Nazanin Alavi

Principal investigator

Queen's University

研究点 (2)

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