Attentional Control Training for Treating Alcohol Use Disorder

NCT ID: NCT05102942

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Use Disorder (AUD) Attentional Bias

Keywords

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Cognitive bias Attentional bias Alcohol use disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

Attentional Control Training Program

Intervention Type 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 B: a gamified AACTP sham-control application + TAU

Group Type PLACEBO_COMPARATOR

Attentional Control Training Program

Intervention Type 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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kjeld Andersen

Clinical professor, consultant psychiatrist, Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KABS City

Valby, Capital Region of Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Angelina I Mellentin, Ph.D

Role: CONTACT

Phone: +4550517901

Email: [email protected]

Anette Søgaard Nielsen, Ph.D.

Role: CONTACT

Phone: +4529135825

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 34899419 (View on PubMed)

Other Identifiers

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71941

Identifier Type: -

Identifier Source: org_study_id