Protocol for a randomised controlled trial of cognitive bias modification training during inpatient withdrawal from alcohol use disorder

Trials. 2018 Nov 1;19(1):598. doi: 10.1186/s13063-018-2999-3.

Abstract

Background: People with alcohol use disorders often exhibit an "alcohol approach bias", the automatically triggered action tendency to approach alcohol. Approach bias is likely to persist following withdrawal from alcohol, and contribute to the high rate of relapse following withdrawal treatment. Cognitive bias modification (CBM) training has been shown to attenuate approach biases and lead to reduced relapse rates. However, no large multisite trial of CBM specifically within a residential withdrawal treatment setting has previously been conducted. This study aims to test whether CBM delivered during residential withdrawal treatment leads to reduced relapse rates and reduced use of acute health services following discharge, and to test possible moderators of CBM's effect on alcohol use.

Methods: Three hundred alcohol-dependent inpatients are being recruited from three withdrawal treatment units in the Melbourne metropolitan area. Participants complete baseline measures of alcohol approach bias and cue-evoked desire for alcohol, followed by four daily sessions of computerised CBM training (or sham training if randomised to the control group). Approach bias and cue-evoked desire are re-assessed following the fourth training session. Follow-up assessments administered 2 weeks and 3, 6, and 12 months following discharge from the withdrawal treatment unit compare abstinence rates and acute and emergency healthcare service use between conditions. Pre-admission and follow-up substance use is derived from the timeline follow-back method, and approach bias towards alcohol with a computerised Approach Avoidance Task.

Discussion: This study is the first multisite randomised controlled trial of cognitive bias modification delivered during acute alcohol withdrawal treatment. Withdrawal is theoretically an ideal period to deliver neurocognitive interventions due to heightened neuroplasticity and cognitive recovery. If effective, the low cost and easy implementation of CBM training means it could be widely used as a standard part of alcohol withdrawal treatment to improve treatment outcomes. Moderation analyses may help better determine whether certain subgroups of patients are most likely to benefit from it and therefore should be prioritised for CBM during alcohol withdrawal treatment.

Trial registration: Version 4 of the protocol (dated 1 August 2017) is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12617001241325 . Registered on 25 August 2017 (retrospectively registered).

Keywords: Abstinence; Alcohol use disorder; Alcohol withdrawal treatment; Approach bias; Cognitive bias; Cognitive training; Relapse.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Alcoholism / psychology
  • Alcoholism / therapy*
  • Bias*
  • Cognition
  • Cognitive Behavioral Therapy / methods*
  • Cues
  • Double-Blind Method
  • Humans
  • Inpatients
  • Multicenter Studies as Topic
  • Outcome Assessment, Health Care
  • Randomized Controlled Trials as Topic*
  • Sample Size