Menu
Recruiting NCT05102942

Attentional Control Training for Treating Alcohol Use Disorder

No phase Interventional Alcohol Use Disorder (AUD) Attentional Bias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Attentional Control Training Program.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder (AUD), Attentional Bias. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Attentional Control Training Program
    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 outcome measures

  • Alcohol consumption [Time frame: Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up]
Secondary outcome measures (3)
  • Cravings [Time frame: Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up]
  • Readiness to change [Time frame: Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up]
  • Affective state [Time frame: Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • KABS City — Valby

Publications

  • Mellentin AI, Cox WM, Fadardi JS, Martinussen L, Mistarz N, Skot L, Romer Thomsen K, Mathiasen K, Lichtenstein M, Nielsen AS. A Randomized Controlled Trial of Attentional Control Training for Treating Alcohol Use Disorder. Front Psychiatry. 2021 Nov 26;12:748848. doi: 10.3389/fpsyt.2021.748848. eCollection 2021. PMID 34899419

Identifiers

NCT: NCT05102942 · 71941

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗