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Attentional Control Training for Treating Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder (AUD), Attentional Bias

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Attentional Control Training Program
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder (AUD)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    No Intervention

    Arm Label

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

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

    Group C: only TAU

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    September 18, 2021
    Last Updated
    February 4, 2022
    Sponsor
    University of Southern Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05102942
    Brief Title
    Attentional Control Training for Treating Alcohol Use Disorder
    Official Title
    A Randomized Controlled Trial of Attentional Control Training for Treating Alcohol Use Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Southern Denmark

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder (AUD), Attentional Bias

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    317 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: a gamified AACTP smartphone application + treatment as usual (TAU)
    Arm Type
    Experimental
    Arm Title
    Group B: a gamified AACTP sham-control application + TAU
    Arm Type
    Placebo Comparator
    Arm Title
    Group C: only TAU
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Attentional Control Training Program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Alcohol consumption
    Description
    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.
    Time Frame
    Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up
    Secondary Outcome Measure Information:
    Title
    Cravings
    Description
    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.
    Time Frame
    Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up
    Title
    Self-efficacy
    Description
    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.
    Time Frame
    Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up
    Title
    Readiness to change
    Description
    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.
    Time Frame
    Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up
    Title
    Affective state
    Description
    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.
    Time Frame
    Baseline, post-treatment (12-weeks after baseline) and 12- and 24-weeks post-treatment follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Angelina I Mellentin, Ph.D
    Phone
    +4550517901
    Email
    amellentin@health.sdu.dk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anette Søgaard Nielsen, Ph.D.
    Phone
    +4529135825
    Email
    ansnielsen@health.sdu.dk

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The datasets pertaining to the study are available on request from the authors, provided this is compliant with national legislations and with the decisions of the ethical committees of the respective countries.
    Citations:
    PubMed Identifier
    34899419
    Citation
    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.
    Results Reference
    derived

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