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

Núria Mallorquí-Bagué; Alba Palazón-Llecha; Mercè Madre; Francesca Batlle; Santiago Duran-Sindreu; Joan Trujols

doi:10.3389/fpsyt.2023.1051528

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

Front Psychiatry. 2023 Mar 2:14:1051528. doi: 10.3389/fpsyt.2023.1051528. eCollection 2023.

Authors

Núria Mallorquí-Bagué^{1

2}, Alba Palazón-Llecha^{1

2}, Mercè Madre¹, Francesca Batlle¹, Santiago Duran-Sindreu^{1

3}, Joan Trujols^{1

3}

Affiliations

¹ Addictive Behaviors Unit, Department of Psychiatry, Biomedical Research Institute Sant Pau (IIB Sant Pau), Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
² Department of Psychology, University of Girona, Girona, Spain.
³ Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.

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.

Keywords: clinical trial; cocaine use disorder; cognitive behavioral therapy; gender; predictive factors; protocol; treatment; treatment outcome.

Associated data

ClinicalTrials.gov/NCT05207228

Grants and funding

This study was financed by a governmental grant from the Spanish Ministry of Science, Innovation and Universities, Instituto Carlos III (ISCIII) (FIS PI20/00929) and co-funded by FEDER funds a way to build Europe, and Fundació Privada Hospital de la Santa Creu i Sant Pau (Pla d'acció social 2020). The funding sources have played no role in the study design or preparation of this protocol and will have no role in the execution of the study, analyses and interpretation of data, or decision to submit results for publication.