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Trial registered on ANZCTR
Registration number
ACTRN12625000036415
Ethics application status
Approved
Date submitted
18/12/2024
Date registered
16/01/2025
Date last updated
16/01/2025
Date data sharing statement initially provided
16/01/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Alcohol Cue Exposure and Virtual Reality Project
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Scientific title
A randomised controlled trial of a novel, neuropsychological feedback intervention for alcohol use disorder: Using novel technologies to understand and target the cognitive-affective mechanisms underpinning harmful drinking behaviours in people with alcohol use disorder aged 18-55 years old
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Secondary ID [1]
312675
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
ACE-VR Karaoke
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder
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Condition category
Condition code
Mental Health
331236
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All participants (even those in the active control group) complete a single 2-2.5 hour assessment session with a provisionally registered psychologist. This involves completing an online Qualtrics survey containing self-report questionnaires and a gamified battery of neuropsychological tests designed to assess expert-endorsed executive functions most relevant to addictions.
The Qualtrics survey, which is completed at baseline / the beginning of the neuropsychological assessment, contains questions regarding the individual's demographic and clinical characteristics, such as age, sex, age of first full serve of alcohol, etc. It also contains clinical and drinking-related questionnaires such as those used to evaluate intervention outcomes, such as the Penn Alcohol Craving Scale to measure craving; Depression, Anxiety, and Stress Scale to measure psychological distress; and the Brief Situational Confidence Questionnaire to measure alcohol-related self-efficacy. Participants also complete the Test of Premorbid Functioning at baseline, which provides an estimate of their premorbid functioning (i.e., overall level of cognitive functioning before the onset of any illness or injury). The gamified cognitive assessment battery (Lee et al., 2023) features gamified versions of the following tasks: Stop Signal Task (SST) to measure response inhibition; Value-Modulated Attentional Capture Task (VMAC) to measure reward-related attentional bias, and the additional reversal component of the task (VMAC-R) measures persistence of reward-related attentional bias or cognitive inflexibility; Sequential Decision-Making Task (SDT) to measure habitual decision-making; Balloon Analogue Risk Task (BART) to measure risky decision-making; and the Delay Discounting Task (DDT) to measure delay discounting, that is, the extent to which the value of a reward decreases as the delay to obtaining that reward increases. These tasks are completed on a computer in the assessment room under the observation of the provisionally registered psychologist.
Fifteen participants will be randomly selected to receive personalised neuropsychological feedback two weeks following the assessment. Feedback is provided both verbally (i.e., a 30-minute telephone session) and in written format (i.e., in the form of a short two-page letter/report) emailed to the participant at the beginning of their telephone feedback session. Individuals in the intervention group receive feedback on their levels of drinking, coping, craving, and drinking motives, as well as on their cognitive profile (i.e., their neurocognitive test performances). The feedback involves both normative and within-individual/premorbid comparisons. Individuals also receive psychoeducation regarding how their current cognitive functioning impacts their specific drinking patterns and vice versa. Alcohol harm reduction strategies are also provided during the telephone call and listed on the feedback letter, accompanied by follow-up, Australian alcohol and other drug (AOD) and crisis hotlines. Alcohol harm reduction strategies included those commonly listed on Australian government websites, such as "Drink water or other non-alcohol beverages between alcoholic drinks".
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Intervention code [1]
329203
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Behaviour
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Comparator / control treatment
All participants (just like the intervention group above) complete a single 2-2.5 hour assessment session with a provisionally registered psychologist. This involves completing an online Qualtrics survey containing self-report questionnaires and a gamified battery of neuropsychological tests designed to assess expert-endorsed executive functions most relevant to addictions.
The Qualtrics survey, which is completed at baseline / the beginning of the neuropsychological assessment, contains questions regarding the individual's demographic and clinical characteristics, such as age, sex, age of first full serve of alcohol, etc. It also contains clinical and drinking-related questionnaires such as those used to evaluate intervention outcomes, such as the Penn Alcohol Craving Scale to measure craving; Depression, Anxiety, and Stress Scale to measure psychological distress; and the Brief Situational Confidence Questionnaire to measure alcohol-related self-efficacy. Participants also complete the Test of Premorbid Functioning at baseline, which provides an estimate of their premorbid functioning (i.e., overall level of cognitive functioning before the onset of any illness or injury). The gamified cognitive assessment battery (Lee et al., 2023) features gamified versions of the following tasks: Stop Signal Task (SST) to measure response inhibition; Value-Modulated Attentional Capture Task (VMAC) to measure reward-related attentional bias, and the additional reversal component of the task (VMAC-R) measures persistence of reward-related attentional bias or cognitive inflexibility; Sequential Decision-Making Task (SDT) to measure habitual decision-making; Balloon Analogue Risk Task (BART) to measure risky decision-making; and the Delay Discounting Task (DDT) to measure delay discounting, that is, the extent to which the value of a reward decreases as the delay to obtaining that reward increases. These tasks are completed on a computer in the assessment room under the observation of the provisionally registered psychologist.
Fifteen participants will be randomly selected to receive personalised feedback two weeks following the assessment (i.e., a traditional brief intervention for alcohol use). Feedback is provided both verbally (i.e., a 30-minute telephone session) and in written format (i.e., in the form of a short two-page letter/report) emailed to the participant at the beginning of their telephone feedback session. Individuals in the active control group receive feedback on their levels of drinking, coping, craving, and drinking motives, as well as on their current psychological functioning (i.e., current depression, anxiety, and stress symptoms). Individuals also receive psychoeducation regarding how their current psychological functioning/mood impacts their specific drinking patterns and vice versa. Alcohol harm reduction strategies are also provided during the telephone call and listed on the feedback letter, accompanied by follow-up, Australian alcohol and other drug (AOD) and crisis hotlines. Alcohol harm reduction strategies included those commonly listed on Australian government websites, such as "Drink water or other non-alcohol beverages between alcoholic drinks".
Hence, the only difference between treatment groups is that the intervention group above receives feedback on their cognition and relevant psychoeducation, while the active control group receive feedback on their current mood and relevant psychoeducation instead.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change, relative to baseline, in the the standard drinks consumed per drinking day (i.e., change in drinking intensity).
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Assessment method [1]
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The Timeline Follow-Back will be used to measure standard drinks per drinking day (i.e., drinking intensity). This outcome is calculated by dividing total standard drinks consumed (primary outcome 1) by drinking days (i.e., primary outcome 2). For example, if an individual consumed 100 standard drinks in the two-week time period, across 5 drinking days, then their estimated drinks per drinking day would be 20 standard drinks per drinking day.
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Timepoint [1]
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Baseline: self-reported at the beginning of the feedback session for their alcohol use in the two weeks prior to the feedback session. Post-intervention: two weeks after their feedback session.
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Primary outcome [2]
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Change, relative to baseline, in the number of drinking days defined as the days in which alcohol was consumed (i.e., change in drinking frequency).
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Assessment method [2]
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The Timeline Follow-Back will be used to measure number of drinking days in the two-week timeframe (i.e., change in drinking frequency).
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Timepoint [2]
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Baseline: self-reported at the beginning of the feedback session for their alcohol use in the two weeks prior to the feedback session. Post-intervention: two weeks after their feedback session, similarly self-reported but over an online Qualtrics survey.
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Primary outcome [3]
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Change, relative to baseline, in the number of total standard drinks consumed (i.e., change in drinking quantity).
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Assessment method [3]
339393
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The Timeline Follow-Back will be used to measure total standard drinks in the two-week timeframe (i.e., change in drinking quantity).
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Timepoint [3]
339393
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Baseline: self-reported at the beginning of the feedback session for their alcohol use in the two weeks prior to the feedback session. Post-intervention: two weeks after their feedback session, similarly self-reported but over an online Qualtrics survey.
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Secondary outcome [1]
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Acceptability of the intervention compared to the active control - this is another primary outcome of the study
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Assessment method [1]
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Acceptability will be assessed by the proportion of people who complete the feedback session and follow-up survey, as well as participants' positive rating of the neuropsychological feedback intervention on a Likert acceptability scale designed specifically for the study. Questions relate to the usefulness and understanding of the feedback, as well as feedback preferences (i.e., feedback length and format).
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Timepoint [1]
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Post-intervention: two weeks after their feedback session
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Secondary outcome [2]
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Change, relative to baseline, in alcohol craving
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Assessment method [2]
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Penn Alcohol Craving Scale (PACS) total score
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Timepoint [2]
439750
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Baseline: two weeks prior to the feedback session Post-intervention: two weeks after their feedback session
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Secondary outcome [3]
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Change, relative to baseline, in self-efficacy to resist alcohol use in tempting situations.
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Assessment method [3]
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Brief Situational Confidence Questionnaire (BSCQ) total score
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Timepoint [3]
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Baseline: two weeks prior to the feedback session Post-intervention: two weeks after their feedback session
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Secondary outcome [4]
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Change, relative to baseline, in Psychological Distress
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Assessment method [4]
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Depression, Anxiety, and Stress Scale - 21 items (DASS-21) total score
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Timepoint [4]
439752
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Baseline: two weeks prior to the feedback session Post-intervention: two weeks after their feedback session
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Eligibility
Key inclusion criteria
1) aged 18-55 years old; 2) willing and able to provide informed consent for the study; 3) meet Diagnostic and Statistical Manual, Fifth Edition (DSM-5) Diagnostic Criteria for Alcohol Use Disorder measured by the Mini-International Neuropsychiatric Interview (MINI); 4) sufficient English language proficiency to understand the intervention content and task instructions; 5) adequate visual and auditory acuity to complete cognitive assessments; estimated full-scale intelligent quotient (FSIQ) of at least 80 measured by the Test of Premorbid Functioning (TOPF).
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(1) lifetime diagnosis of DSM-5 defined psychotic illness measured using the MINI; (2) current diagnosis of Bipolar Disorder Type 1 (manic episodes) measured using the MINI; 3) diagnosis of a neurological condition (e.g., stroke, dementia, epilepsy) or moderate-severe brain injury (i.e., loss of consciousness for over 30 minutes, or ongoing cognitive/neurological impairment), 4) lifetime diagnosis of intellectual disability or with an FSIQ of below 80; 5) colour blind or significant hearing or visual impairment; 6) non-fluency in English; 7) currently pregnant or breastfeeding.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
10/07/2023
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Date of last participant enrolment
Anticipated
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Actual
29/03/2024
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Date of last data collection
Anticipated
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Actual
12/04/2024
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Sample size
Target
50
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Accrual to date
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Final
49
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
317110
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University
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Name [1]
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Monash University
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Address [1]
317110
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Country [1]
317110
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Australia
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Funding source category [2]
318054
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Government body
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Name [2]
318054
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Australian Government - Department of Education - Research Training Program Stipend
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Address [2]
318054
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Country [2]
318054
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
319367
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None
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Name [1]
319367
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Address [1]
319367
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Country [1]
319367
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315859
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
315859
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Australia
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Date submitted for ethics approval [1]
315859
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08/11/2022
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Approval date [1]
315859
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12/01/2023
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Ethics approval number [1]
315859
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30595
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Summary
Brief summary
Many Australians do not realise that they engage in harmful drinking behaviours and meet diagnostic criteria for alcohol use disorder (AUD). If they are aware, many do not feel motivated to reduce or cease their drinking. While brief motivational interventions have been shown to increase motivation to reduce drinking and therefore, improve treatment outcomes in individuals with AUD, effect sizes are modest at best. Neuropsychological feedback (NPF) is an evidence-based intervention that can be delivered as a brief intervention, and has been found to improve clinical outcomes in other neuropsychological and mental health conditions. Yet, its efficacy and acceptability for AUD remain unclear. In this RCT, we aimed to investigate the efficacy and acceptability of NPF for AUD, compared with an active control, a brief motivational intervention. We hypothesised that adults with AUD who receive NPF would show greater reduction in alcohol use and greater improvement in clinical outcomes (i.e., alcohol craving, psychological distress, and alcohol-related self-efficacy) than those who receive a traditional brief motivational intervention.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Rico Sze Chun Lee
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Address
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Redmond Barry Building (115), The University of Melbourne, 17 Spencer Road, Parkville VIC 3010
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Country
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Australia
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Phone
136014
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+61 03 8344 6377
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Fax
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Email
136014
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[email protected]
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Contact person for public queries
Name
136015
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Rico Sze Chun Lee
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Address
136015
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Redmond Barry Building (115), The University of Melbourne, 17 Spencer Road, Parkville VIC 3010
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Country
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Australia
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Phone
136015
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+61 03 8344 6377
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Fax
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Email
136015
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[email protected]
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Contact person for scientific queries
Name
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Lara Piccoli
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Address
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Monash Biomedical Imaging, Monash University, 762-772 Blackburn Rd, Clayton VIC 3168
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Country
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Australia
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Phone
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+61 3 9905 0100
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Fax
136016
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Email
136016
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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