RESUMO
BACKGROUND: Alcohol use disorder (AUD) is characterized by problematic alcohol use accompanied by clinically substantial distress. Patients with AUD frequently experience high relapse rates, and only 1 in 5 remain abstinent 12 months post treatment. Traditional face-to-face relapse prevention therapy (RPT) is a form of cognitive behavioral therapy (CBT) 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. A web-based 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. OBJECTIVE: This study protocol aims to establish the first academic e-RPT program to address AUD in the general population. The primary objective of this study is to compare the efficacy of e-RPT to face-to-face RPT in decreasing relapse rates. The secondary objective is to assess the effects of e-RPT on quality of life, self-efficacy, resilience, and depressive symptomatology. The tertiary objective is to evaluate the cost-effectiveness of e-RPT compared to face-to-face RPT. METHODS: Adult participants (n=60) with a confirmed diagnosis of AUD will be randomly assigned to receive 10 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 comprise 10 one-hour 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, amid treatment, and at the end of treatment. RESULTS: Participant recruitment is expected to begin in October 2022 through targeted advertisements and physician referrals. Completed data collection and analysis are expected to conclude by October 2023. Outcome data will be assessed using linear and binomial regression (for continuous and categorical outcomes, respectively). Qualitative data will be analyzed using thematic analysis methods. CONCLUSIONS: This study will be the first to examine the effectiveness of e-RPT compared to face-to-face RPT. It is posited that web-based care can present benefits in terms of accessibility and affordability compared to traditional face-to-face psychotherapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05579210; https://clinicaltrials.gov/ct2/show/NCT05579210. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44694.
RESUMO
BACKGROUND: The demand for mental health care, particularly for depression and anxiety, is 3-fold greater among patients receiving oncologic and palliative care than for the general population. This population faces unique barriers, making them more susceptible to mental health challenges. Various forms of psychotherapy have been deemed effective in addressing mental health challenges in this population, including supportive psychotherapy, cognitive behavioral therapy, problem-based therapy, and mindfulness; however, their access to traditional face-to-face psychotherapy resources is limited owing to their immunocompromised status, making frequent hospital visits dangerous. Additionally, patients can face hospital fatigue from numerous appointments and investigations or may live in remote areas, which makes commutes both physically and financially challenging. Web-based psychotherapy is a promising solution to address these accessibility barriers. Moreover, web-based psychotherapy has been proven effective in addressing depression and anxiety in other populations and may be implementable among patients receiving oncologic and palliative care. OBJECTIVE: The study will investigate the feasibility and effectiveness of web-based psychotherapy among patients receiving oncologic and palliative care, who have comorbid depression or anxiety. We hypothesized that this program will be a viable and efficacious treatment modality compared to current treatment modalities in addressing depression and anxiety symptoms in this population. METHODS: Participants (n=60) with depression or anxiety will be recruited from oncology and palliative care settings in Kingston (Ontario, Canada). Participants will be randomly allocated to receive either 8 weeks of web-based psychotherapy plus treatment as usual (treatment arm) or treatment as usual exclusively (control arm). The web-based psychotherapy program will incorporate cognitive behavioral therapy, mindfulness, and problem-solving skills, and homework assignments with personalized feedback from a therapist. All web-based programs will be delivered through a secure platform specifically designed for web-based psychotherapy delivery. To evaluate treatment efficacy, all participants will complete standardized symptomology questionnaires at baseline, midpoint (week 4), and posttreatment. RESULTS: The study received ethics approval in February 2021 and began recruiting participants in April 2021. Participant recruitment has been conducted through social media advertisements, physical advertisements, and physician referrals. To date, 11 participants (treatment, n=5; control, n=4; dropout, n=2) have been recruited. Data collection and analysis are expected to conclude by December 2021 and January 2022, respectively. Linear regression (for continuous outcomes) will be conducted with interpretive qualitative methods. CONCLUSIONS: Our findings can be incorporated into clinical policy and help develop more accessible mental health treatment options for patients receiving oncologic and palliative care. Asynchronous and web-based psychotherapy delivery is a more accessible, scalable, and financially feasible treatment that could have major implications on the health care system. TRIAL REGISTRATION: ClinicalTrials.gov NCT04664270; https://clinicaltrials.gov/ct2/show/NCT04664270. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30735.
