Trial Review

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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
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
Secondary ID [1] 312675 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACE-VR Karaoke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder 334662 0
Condition category
Condition code
Mental Health 331236 331236 0 0
Addiction

Intervention/exposure
Study type
Interventional
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".
Intervention code [1] 329203 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 340287 0
Change, relative to baseline, in the the standard drinks consumed per drinking day (i.e., change in drinking intensity).
Timepoint [1] 340287 0
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.
Primary outcome [2] 340182 0
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).
Timepoint [2] 340182 0
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.
Primary outcome [3] 339393 0
Change, relative to baseline, in the number of total standard drinks consumed (i.e., change in drinking quantity).
Timepoint [3] 339393 0
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.
Secondary outcome [1] 439754 0
Acceptability of the intervention compared to the active control - this is another primary outcome of the study
Timepoint [1] 439754 0
Post-intervention: two weeks after their feedback session
Secondary outcome [2] 439750 0
Change, relative to baseline, in alcohol craving
Timepoint [2] 439750 0
Baseline: two weeks prior to the feedback session Post-intervention: two weeks after their feedback session
Secondary outcome [3] 439751 0
Change, relative to baseline, in self-efficacy to resist alcohol use in tempting situations.
Timepoint [3] 439751 0
Baseline: two weeks prior to the feedback session Post-intervention: two weeks after their feedback session
Secondary outcome [4] 439752 0
Change, relative to baseline, in Psychological Distress
Timepoint [4] 439752 0
Baseline: two weeks prior to the feedback session Post-intervention: two weeks after their feedback session

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).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/07/2023
Date of last participant enrolment
Anticipated
Actual
29/03/2024
Date of last data collection
Anticipated
Actual
12/04/2024
Sample size
Target
50
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317110 0
University
Name [1] 317110 0
Monash University
Country [1] 317110 0
Australia
Funding source category [2] 318054 0
Government body
Name [2] 318054 0
Australian Government - Department of Education - Research Training Program Stipend
Country [2] 318054 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319367 0
None
Name [1] 319367 0
Address [1] 319367 0
Country [1] 319367 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315859 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315859 0
Ethics committee country [1] 315859 0
Australia
Date submitted for ethics approval [1] 315859 0
08/11/2022
Approval date [1] 315859 0
12/01/2023
Ethics approval number [1] 315859 0
30595

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136014 0
Dr Rico Sze Chun Lee
Address 136014 0
Redmond Barry Building (115), The University of Melbourne, 17 Spencer Road, Parkville VIC 3010
Country 136014 0
Australia
Phone 136014 0
+61 03 8344 6377
Fax 136014 0
Email 136014 0
[email protected]
Contact person for public queries
Name 136015 0
Rico Sze Chun Lee
Address 136015 0
Redmond Barry Building (115), The University of Melbourne, 17 Spencer Road, Parkville VIC 3010
Country 136015 0
Australia
Phone 136015 0
+61 03 8344 6377
Fax 136015 0
Email 136015 0
[email protected]
Contact person for scientific queries
Name 136016 0
Lara Piccoli
Address 136016 0
Monash Biomedical Imaging, Monash University, 762-772 Blackburn Rd, Clayton VIC 3168
Country 136016 0
Australia
Phone 136016 0
+61 3 9905 0100
Fax 136016 0
Email 136016 0
[email protected]

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.