Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05102942

Attentional Control Training for Treating Alcohol Use Disorder

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcoholism Attentional Bias Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KABS City

Valby, Capital Region of Denmark, 2500, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

To be eligible to participate, patients must fulfill the following criteria.

Inclusion criteria

They must (1) sign written informed consent, (2) be between 18 and 65 years old (because the intervention is web-based), (3) be fluent in Danish, (4) have completed detoxification (if deemed appropriate), (5) have been admitted to primary treatment within the past eight weeks.

Exclusion criteria

Be color-blind, have a severe psychiatric or neurological illness (e.g., a psychotic disorder, intellectual disability, dementia) or terminal physical illness.

Treatment and study plan

Attentional Control Training Program

Behavioral

The 268 patients fulfilling the eligibility criteria will be randomized to one of the three groups: Group A: AACTP delivered via a smartphone application + treatment as usual (TAU; n = 134), or Group B: ACTP sham training delivered via a smartphone application + TAU (n = 134) Patients in Group A will receive seven sessions of AACTP (one session per week for seven weeks). Patients in Group B will receive seven sessions of sham training (one session per week for seven weeks).

Primary outcomes

  1. 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

  1. Cravings

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

    A visual analog scale (VAS) will be used to measure patients' alcohol cravings on a scale ranging from 0 to 10, with 0 indicating no craving at all and 10 indicating extreme craving. The scale will be presented visually on a ruler, and patients will be asked to indicate their mean and peak level of craving during the past 30 days.

  2. Readiness to change

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

    The Readiness-to-Change Questionnaire Treatment Version (RTCQ-TV) is a 12-item measure of patients' stated intentions to change their drinking, which includes the following sub-scales: (1) pre-contemplation, (2) contemplation, and (3) action stages. Four items pertain to each sub-scale, and each item is rated on a 5-point Likert Scale ranging from strongly agree (-2) to strongly disagree (+2). The total score can range from -24 to +24.

  3. Affective state

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

    The Positive and Negative Affect Schedule (PANAS) is a 20-item measure of the patient's affective states, which includes two sub-scales: (1) positive affect and (2) negative affect. Ten items pertain to each sub-scale, and each item is rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). The total score can range from 20 to 100.

Study contacts

Contact information is provided by the study sponsor or research team.

Anette Søgaard Nielsen, Ph.D.

CONTACT

[email protected]

+4529135825

Angelina I Mellentin, Ph.D

CONTACT

[email protected]

+4550517901

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 2, 2021
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.