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Clinical Trials/NCT05102942
NCT05102942
Recruiting
Not Applicable

A Randomized Controlled Trial of Attentional Control Training for Treating Alcohol Use Disorder

University of Southern Denmark1 site in 1 country268 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Use Disorder (AUD)
Sponsor
University of Southern Denmark
Enrollment
268
Locations
1
Primary Endpoint
Alcohol consumption
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Background: There is consistent evidence that community and clinical samples of individuals with an alcohol use disorder (AUD) have attentional biases toward alcohol cues. The alcohol attentional control training program (AACTP) has shown promise for retraining these biases and decreasing alcohol consumption in community samples of excessive drinkers. However, there is a lack of evidence regarding the effectiveness of ACTP in clinical AUD samples. The main aim of the present study is to investigate whether primary pharmacological and psychological, evidence-based alcohol treatment can be enhanced by the addition of a gamified AACTP smartphone application for patients with an AUD.

Design and methods: The study will be implemented as a randomized controlled trial. A total of 268 consecutively enrolled patients with AUD will be recruited from alcohol outpatient clinics in Denmark. Patients will be randomized to one of three groups upon initiation of primary alcohol treatment: Group A: a gamified AACTP smartphone application + treatment as usual (TAU); or Group B: a gamified AACTP sham-control application + TAU. Treatment outcomes will be assessed at baseline, post-treatment, and at 3- and 6-month follow-ups. Repeated measures MANOVA will be used to compare the trajectories of the groups over time on alcohol attentional bias, alcohol craving, and drinking reductions. It is hypothesized that Group A will achieve better treatment outcomes than either Group B.

Perspectives: Because attentional bias for alcohol cues is proportional to the amount of alcohol consumed, and these biases are not addressed within current evidence-based treatment programs, this study is expected to provide new evidence regarding the effectiveness of the gamified AACTP in a clinical population. Furthermore, due to promising results found using AACTP in community samples of excessive drinkers, there is a high probability that the AACTP treatment in this study will also be effective, thereby allowing AACTP to be readily implemented in clinical settings. Finally, it is expected that this study will increase the effectiveness of evidence-based AUD treatment and introduce a new, low-cost gamified treatment targeting patients with an AUD. Overall, this study is likely to have an impact at the scientific, clinical, and societal levels.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
April 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kjeld Andersen

Clinical professor, consultant psychiatrist, Ph.D

University of Southern Denmark

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Alcohol consumption

Time Frame: Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up

Alcohol consumption will be measured with the Alcohol Timeline Follow-back (TLFB) method. It involves using a calendar to help the patient retrospectively recall the number of drinks that he/she consumed on each day during the previous three months. The results will be used to calculate change over time in various alcohol consumption measures, including weekly mean drinking, which will be the primary outcome measure. To validate the TLFB, hair samples from the patients will be tested for ethyl glucuronide (ETG) by liquid chromatography-tandem mass spectrometry (LC-MS/MS). This biological marker of alcohol consumption will be collected and analyzed according to the Society for Hair Testing.

Secondary Outcomes

  • Cravings(Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up)
  • Readiness to change(Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up)
  • Affective state(Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up)

Study Sites (1)

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