Attentional Control Training for Treating Alcohol Use Disorder

NCT05102942 | Recruiting DMC

• 1 other identifier: 71941
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder (AUD); Attentional Bias

Keywords

Cognitive bias; Attentional bias; Alcohol use disorder

Outcome Measures

Primary Outcomes (1)

• Alcohol consumption

  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.

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

Secondary Outcomes (3)

• 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 Arms (2)

Group A: a gamified AACTP smartphone application + treatment as usual (TAU)

EXPERIMENTAL

Behavioral: Attentional Control Training Program

Group B: a gamified AACTP sham-control application + TAU

PLACEBO COMPARATOR

Behavioral: Attentional Control Training Program

Interventions

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).

Group A: a gamified AACTP smartphone application + treatment as usual (TAU); Group B: a gamified AACTP sham-control application + TAU

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

KABS City

Valby, Capital Region of Denmark, 2500, Denmark

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Angelina I Mellentin, Ph.D

CONTACT

+4550517901; amellentin@health.sdu.dk

Anette Søgaard Nielsen, Ph.D.

CONTACT

+4529135825; ansnielsen@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor, consultant psychiatrist, Ph.D

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: November 2, 2021
• Study Start: October 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: April 1, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)