Protocol for an RCT on cognitive bias modification for alcohol use disorders in a religion-based rehabilitation program

BMJ Open. 2022 Sep 21;12(9):e060820. doi: 10.1136/bmjopen-2022-060820.

Abstract

Introduction: Alcohol-related cues trigger relapse in patients with alcohol use disorders (AUDs). These cues may automatically activate motivational approach tendencies. Through computerised cognitive bias modification (CBM), the tendencies of patients with AUD to approach alcohol can be reduced. The present protocol describes a training intervention with approach bias modification (ApBM) incorporating religion-related stimuli as an alternative to alcohol to improve the effectiveness of CBM in a religion-based rehabilitation centre. AUD is often related to patients' religious attitudes in this treatment context. The religion-adapted ApBM, therefore, combines training in avoidance of alcohol-related motivational cues and an approach to religion-based motivational cues. This combination's effectiveness will be compared with a standard ApBM and to a sham ApBM.

Methods and analysis: Using a double-blind multiarm parallel randomised controlled trial procedure (ratio 1:1:1), 120 patients with AUD will be randomised into 1 of 3 conditions (religion-adapted ApBM, standard ApBM or sham ApBM) with personalised stimuli. The interventions are delivered over 4 consecutive days during an inpatient detoxification programme in addition to treatment as usual. Assessments occur before the start of the training and after the fourth training session, with follow-up assessments after 1 and 4 months. A multivariate analysis of variance will be used with the primary outcomes, the percentage of days abstinent and meaning in life 4-month follow-up. Secondary outcomes include differences in reported training satisfaction and symptoms of AUD.

Ethics and dissemination: This study has been reviewed and approved by the Medical Research Ethics Committee Academic Medical Center Amsterdam (Reference number: 2020_251). Further, study results will be published in peer-reviewed journals and presented at international conferences.

Trial registration number: NL75499.018.20.

Keywords: Clinical trials; Impulse control disorders; Substance misuse.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Alcoholism* / psychology
  • Alcoholism* / therapy
  • Cognition
  • Cognitive Behavioral Therapy* / methods
  • Cues
  • Humans
  • Neoplasm Recurrence, Local
  • Randomized Controlled Trials as Topic
  • Religion