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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05120856
Registration number
NCT05120856
Ethics application status
Date submitted
22/10/2021
Date registered
15/11/2021
Date last updated
20/05/2024
Titles & IDs
Public title
AAT-App Outpatient Trial
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Scientific title
AAT-App Trial: A Clinical Trial of a "Brain-training" Smartphone App to Help Reduce Alcohol Use in People Accessing Outpatient Alcohol Treatment
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Secondary ID [1]
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ADRIA045
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Universal Trial Number (UTN)
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Trial acronym
AAT-App
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder (AUD)
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Condition category
Condition code
Mental Health
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Addiction
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - AAT-App
Behaviour - Minimal AAT-App
Experimental: Active AAT-App - Participants will receive the active AAT-App.
Sham Comparator: Minimal AAT-App - Participants will receive the minimal version of AAT-App.
Behaviour: AAT-App
Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Behaviour: Minimal AAT-App
Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from Baseline in Number of Standard Drinks Consumed Per Week at Post-Intervention and Follow-Up Assessments
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Assessment method [1]
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Participants will estimate the number of standard drinks of alcohol consumed on each day within the past week, using a timeline follow-back assessment. Participants will select a number, ranging from 0-80, to estimate how many standard drinks they consumed on each day in that week. Past-week standard drinks will be calculated using the sum of values for each of the past 7 days.
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Timepoint [1]
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Baseline; Post-Intervention (Primary Endpoint), defined as 28 days after commencing use of the app; and both 1-Month and 3-Month Follow Ups (Secondary Endpoints)
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Secondary outcome [1]
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Change from Baseline in Past-Week Frequency of Alcohol Cravings on the Craving Experience Questionnaire Frequency Scale (CEQ-F) at Post-Intervention and Follow-Up Assessments
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Assessment method [1]
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The Craving Experience Questionnaire frequency scale (CEQ-F) is a validated, 10-item scale, with each item rated on a scale of 0-10. Total scores are calculated based on the mean of individual items. 3 subscale scored can also be calculated: "intensity" (3 items), "imagery" (4 items), and "intrusiveness" (3 items). Secondary analyses will be conducted for each of its 3 subscales.
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Timepoint [1]
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Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
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Secondary outcome [2]
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Change from Baseline in Alcohol Dependence Scores on the Severity of Dependence Scale (SDS) at Post-Intervention and Follow-Up Assessments
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Assessment method [2]
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The Severity of Dependence Scale (SDS) is a validated, 5-item scale, with each item scored 0-3. Total scores are calculated by summing individual item scores.
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Timepoint [2]
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Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
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Secondary outcome [3]
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Change from Baseline in Total Scores on the Alcohol Use Disorders Identification Test (AUDIT) at 3-Month Follow-Up Assessment
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Assessment method [3]
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The Alcohol Use Disorders Identification Test (AUDIT) is a validated, 10-item scale, with each item scored 0-4. Total scores are calculated based on the sum of individual item scores. Given the AUDIT usually enquires about drinking and related problems in the past year, wording of instructions and questions will be modified to ask participants to base answers on the past 3 months so that equivalent, non-overlapping periods can be assessed at both baseline and the 3-month follow-up.
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Timepoint [3]
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Baseline and 3-Month Follow Up
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Secondary outcome [4]
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Change from Baseline in Past-Week Total Heavy Drinking Days (HDD) at Post-Intervention and Follow Up Assessments
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Assessment method [4]
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Participants will estimate the number of standard drinks of alcohol consumed on each day within the past week, using the timeline follow-back assessment as described above. HDDs will be defined as greater than or equal to 5 standard drinks in a day.
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Timepoint [4]
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Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
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Secondary outcome [5]
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Change from Baseline in Proportion of Past-Month Drinking Days at Post-Intervention and Follow Up Assessments
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Assessment method [5]
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At baseline, participants will complete the past-week drinking assessment described above and also report number of drinking days in each of the 3 weeks preceding the past week. Baseline past-month drinking days will be the sum of drinking days for all 4 of these weeks. The app prompts participants to report past-week standard drinks 7, 14, 21, and 28 days after baseline, allowing calculation of past-month drinking days for the intervention period. 1-month and 3-month follow-up assessments will be identical to the baseline assessment. Past-month drinking days will be expressed as a percentage of the days on which a participant could drink (i.e., if they were in residential treatment for 10 days, past-month drinking days will be expressed as a proportion of the 18 days on which they could drink), but data will be excluded if the participant did not have at least 14 days on which they had the opportunity to drink (i.e., if they were within residential/inpatient treatment on 15+ days).
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Timepoint [5]
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Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
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Secondary outcome [6]
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Proportion of Past-Month Heavy Drinking Days
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Assessment method [6]
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Past-month heavy drinking days will be calculated from participants' weekly self-reports of standard drinks consumed each day that they provide during each of the 4 weeks of the intervention period (described above).
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Timepoint [6]
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Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
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Secondary outcome [7]
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Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments
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Assessment method [7]
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Past-week complete abstinence will be defined as zero days in the past week on which any alcohol was consumed.
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Timepoint [7]
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Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
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Secondary outcome [8]
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Proportion of Past-Month Complete Abstinence at Post-Intervention and Follow Up Assessments
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Assessment method [8]
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Participants reporting zero drinking days in the past month will be classified as past-month abstinent.
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Timepoint [8]
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Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
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Secondary outcome [9]
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Change from Baseline in Total Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP) at Post-Intervention and Follow Up Assessments
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Assessment method [9]
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3 items will be adapted from the Australian Treatment Outcomes Profile (ATOP) assessing psychological health, physical health, and overall quality of life over the past 28 days. Each item will be rated on a scale from zero to ten, where zero is poor and ten is good. Each rating will be treated as a separate variable in analyses (i.e., no composite score will be derived from the 3 separate items).
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Timepoint [9]
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Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
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Secondary outcome [10]
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Change from Baseline in Approach Bias at Post-Intervention
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Assessment method [10]
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Approach bias will be assessed within the app using an alcohol approach avoidance task.
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Timepoint [10]
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Baseline and Post-Intervention (28 days after commencing app use)
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Eligibility
Key inclusion criteria
- Own an Android or iOS smartphone with an Australian mobile number.
- Be currently accessing outpatient treatment for alcohol problems. Participants with
multiple drugs of concern are eligible as long as alcohol is one of the drugs of
concern for the current episode of treatment.
- Have an Alcohol Use Disorders Identification Test (AUDIT) score of at least 8.
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Minimum age
18
Years
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Maximum age
No limit
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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
- Any residential rehabilitation within the past 4 weeks.
- Any form of inpatient treatment (e.g. hospital or residential withdrawal treatment)
within the past week.
- Scheduled to enter inpatient/residential treatment within the next month.
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/05/2024
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Sample size
Target
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Accrual to date
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Final
82
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Uniting Vic Tas - Coburg
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Recruitment hospital [2]
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Monash Health (Addiction Medicine Unit) - Dandenong
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Recruitment hospital [3]
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St. Vincent's Hospital Melbourne (Department of Addiction Medicine) - Fitzroy
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Recruitment hospital [4]
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Odyssey House Victoria - Richmond
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Recruitment hospital [5]
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Turning Point - Richmond
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Recruitment hospital [6]
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Star Health - South Melbourne
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Recruitment postcode(s) [1]
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3058 - Coburg
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Recruitment postcode(s) [2]
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3175 - Dandenong
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Recruitment postcode(s) [3]
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3065 - Fitzroy
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Recruitment postcode(s) [4]
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3121 - Richmond
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Recruitment postcode(s) [5]
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3205 - South Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Turning Point
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Monash Health
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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St Vincent's Hospital Melbourne
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Uniting Vic Tas
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Address [3]
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Other collaborator category [4]
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Other
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Star Health
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Other
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Odyssey House
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Ethics approval
Ethics application status
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Summary
Brief summary
Cognitive biases contribute to the difficulty experienced by heavy drinkers wishing to reduce
their alcohol use. Recent interventions designed to reduce cognitive biases demonstrate
efficacy for Approach Bias Modification (ApBM). Reductions in the likelihood of relapse have
been found after ApBM in Alcohol Use Disorder (AUD) patients during residential treatment.
Current methods of ApBM are usually delivered by computer and joystick and come with several
limitations, including accessibility. If ApBM could be shown to be feasible in other
settings, such as outpatient treatment, it could benefit a much larger population with AUD.
This randomised controlled trial will test the efficacy of a recently-developed ApBM
smartphone app called "AAT-App" ("Alcohol Avoidance Training App"). We aim to test whether
AAT-App, relative to a minimal version of the app which excludes ApBM training, is effective
at reducing alcohol use, cravings, severity of dependence, and approach bias (a measure of a
person's automatic tendency to automatically approach alcohol-related stimuli), and to
explore user experiences of AAT-App to guide future improvements to the app and its
implementation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05120856
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Trial related presentations / publications
Eberl C, Wiers RW, Pawelczack S, Rinck M, Becker ES, Lindenmeyer J. Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best? Dev Cogn Neurosci. 2013 Apr;4:38-51. doi: 10.1016/j.dcn.2012.11.002. Epub 2012 Nov 14.
Manning V, Staiger PK, Hall K, Garfield JB, Flaks G, Leung D, Hughes LK, Lum JA, Lubman DI, Verdejo-Garcia A. Cognitive Bias Modification Training During Inpatient Alcohol Detoxification Reduces Early Relapse: A Randomized Controlled Trial. Alcohol Clin Exp Res. 2016 Sep;40(9):2011-9. doi: 10.1111/acer.13163. Epub 2016 Aug 4. Erratum In: Alcohol Clin Exp Res. 2017 Aug;41(8):1526.
Manning V, Garfield JBB, Staiger PK, Lubman DI, Lum JAG, Reynolds J, Hall K, Bonomo Y, Lloyd-Jones M, Wiers RW, Piercy H, Jacka D, Verdejo-Garcia A. Effect of Cognitive Bias Modification on Early Relapse Among Adults Undergoing Inpatient Alcohol Withdrawal Treatment: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Feb 1;78(2):133-140. doi: 10.1001/jamapsychiatry.2020.3446.
Rinck M, Wiers RW, Becker ES, Lindenmeyer J. Relapse prevention in abstinent alcoholics by cognitive bias modification: Clinical effects of combining approach bias modification and attention bias modification. J Consult Clin Psychol. 2018 Dec;86(12):1005-1016. doi: 10.1037/ccp0000321.
Salemink E, Rinck M, Becker E, Wiers RW, Lindenmeyer J. Does comorbid anxiety or depression moderate effects of approach bias modification in the treatment of alcohol use disorders? Psychol Addict Behav. 2022 Aug;36(5):547-554. doi: 10.1037/adb0000642. Epub 2021 Jun 10.
Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006; 3(2): 77-101.
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Public notes
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Contacts
Principal investigator
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Victoria Manning
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Turning Point
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05120856
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