Attentional Control Training for Treating Alcohol Use Disorder

Alcohol Use Disorder (AUD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05102942
• Other study ID #: 71941
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2022
• Source: University of Southern Denmark
• Contact: Angelina I Mellentin, Ph.D
• Phone: +4550517901
• Email: amellentin[@]health.sdu.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 317 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); Group B: a gamified AACTP sham-control application + TAU; or Group C: only 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 or Group C. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 317
• Est. completion date: June 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder (AUD)
• Alcoholism
• Attentional Bias

Intervention

Behavioral:
• Attentional Control Training Program
The 317 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 = 106), Group B: ACTP sham training delivered via a smartphone application + TAU (n = 106), or Group C: TAU only (n = 106). 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). Patients in Group C will receive only the primary treatment for AUD.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cravings	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.	Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up
Secondary	Self-efficacy	The Alcohol Abstinence Self-Efficacy Scale is a 40-item measure of patients' temptation to drink and their perceived self-efficacy in abstaining from drinking in 20 different situations that represent typical cues for drinking. Twenty items pertain to temptation, and 20 items pertain to self-efficacy. Patients will rate each item on a scale ranging from not at all (0) to extremely (4). The measure comprises the following sub-scales: (1) negative affect; (2) social interaction and positive states; (3) physical and other concerns; and (4) withdrawal and urges to drink. Both the temptation and perceived efficacy total score can range from 0 to 80.	Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up
Secondary	Readiness to change	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.	Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up
Secondary	Affective state	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.	Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up