Dataset Information

CBT4CBT web-based add-on treatment for cocaine use disorder: Study protocol for a randomized controlled trial.

ABSTRACT:

Background

Cocaine use disorder (CUD) is a chronic condition that presents high relapse rates and treatment dropouts. Web-based interventions have proven to be effective when optimizing face-to-face treatments in different mental health conditions and have the potential to optimize current CUD treatments. However, web-based interventions in addictive behaviors are still limited. The aim of this study is to evaluate whether adding a web-based cognitive behavioral therapy (i.e., CBT4CBT) to standard CUD treatment, improves treatment outcomes in a Spanish sample of patients with severe CUD (which requires inpatient treatment). Additionally, we aim to explore predictive factors of treatment response and treatment gender-related differences.

Methods

All individuals coming for inpatient cocaine detoxification who meet the inclusion criteria will have the possibility to be part of the study. The participants of this open-label randomized controlled clinical trial (RCT) will be allocated to treatment as usual (TAU) or TAU+CBT4CBT after the hospitalization for cocaine detoxification. During the inpatient treatment they will all receive an individualized psychological intervention. There will be six time point assessments: at 48-72 h of starting inpatient treatment, at the end of inpatient treatment and before starting day care and outpatient treatment, at the end of the 8 weeks CTB4CBT / TAU arm treatment and at three follow-up time points (1-, 3-, and 6-months post-treatment).

Discussion

To the best of our knowledge, this is the first RCT that explores the efficacy of adding a web-based cognitive behavioral therapy to usual CUD treatment with patients of a clinical sample in Europe.

Trial registration

IIBSP-CTB-2020-116, NCT05207228. Submitted 8^th of April 2021, posted 26 ^st of January 2022. https://clinicaltrials.gov/ct2/show/NCT05207228?cond=Cocaine+Use+Disorder&draw=2&rank=1.

SUBMITTER: Mallorqui-Bague N

PROVIDER: S-EPMC10017533 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

CBT4CBT web-based add-on treatment for cocaine use disorder: Study protocol for a randomized controlled trial.

Mallorquí-Bagué Núria N Palazón-Llecha Alba A Madre Mercè M Batlle Francesca F Duran-Sindreu Santiago S Trujols Joan J

Frontiers in psychiatry 20230302

<h4>Background</h4>Cocaine use disorder (CUD) is a chronic condition that presents high relapse rates and treatment dropouts. Web-based interventions have proven to be effective when optimizing face-to-face treatments in different mental health conditions and have the potential to optimize current CUD treatments. However, web-based interventions in addictive behaviors are still limited. The aim of this study is to evaluate whether adding a web-based cognitive behavioral therapy (i.e., CBT4CBT) t ...[more]

PMID: 36937712

Similar Datasets

Project description:BackgroundAntiretroviral therapy is effective in reducing HIV-related morbidity, mortality, and transmission among people with HIV. However, adherence and persistence to antiretroviral therapy are crucial for successful HIV treatment outcomes. People with HIV who use cocaine have poor access to HIV services and lower retention in care.ObjectiveThe primary goal of this paper is to provide a detailed description of a mobile health intervention. This study is designed to improve medication adherence among people with HIV who use cocaine. A secondary goal is to list the important challenges and adaptations incorporated in the study design.MethodsThis study, titled Project SMART, used a wireless technology-based intervention, including cellular-enabled electronic pillboxes called TowerView Health and smartphones, to provide reminders and feedback on adherence behavior. The intervention design was based on the theoretical frameworks provided by the self-determination theory and the Motivation Technology Model. The 12-week pilot randomized controlled trial with four arms provided three types of feedback: automated feedback, automated+clinician feedback, and automated feedback+social network feedback.ResultsThe study was funded by the National Institute of Drug Abuse (R21DA039842) on August 1, 2016. The institutional review board for the study was approved by Yale University on March 21, 2017. Data collection lasted from June 2017 to January 2020. The final enrollment was 71 participants, of whom 57 (80%) completed the study. The data are currently undergoing analysis, and the manuscript is being developed for publication in early 2022.ConclusionsImplementing complex mobile health interventions for high-risk and marginalized populations with multicomponent interventions poses certain challenges, such as finding companies with adequate technology for clients and financial stability and minimizing the research-related burden for the study population. Conducting feasibility studies is important to recognize these challenges and the opportunity to address these challenges with solutions while keeping the design of a randomized controlled trial as true as possible.Trial registrationClinicaltrials.gov NCT04418076; https://clinicaltrials.gov/ct2/show/NCT04418076.International registered report identifier (irrid)DERR1-10.2196/28332.

Project description: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 registrationClinicalTrials.gov NCT05579210; https://clinicaltrials.gov/ct2/show/NCT05579210.International registered report identifier (irrid)PRR1-10.2196/44694.

Dataset Information

CBT4CBT web-based add-on treatment for cocaine use disorder: Study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

CBT4CBT web-based add-on treatment for cocaine use disorder: Study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets