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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05120856
Registration number
NCT05120856
Ethics application status
Date submitted
22/10/2021
Date registered
15/11/2021
Date last updated
16/12/2024
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
BEHAVIORAL - AAT-App
BEHAVIORAL - 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.
BEHAVIORAL: 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.
BEHAVIORAL: 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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BEHAVIORAL
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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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Number of Standard Drinks Consumed Per Week
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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, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
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Secondary outcome [1]
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Past-Week Frequency of Alcohol Cravings (as Measured by the Craving Experience Questionnaire Frequency Scale - CEQ-F)
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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. Higher scores indicate more frequent craving experiences. Three 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, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
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Secondary outcome [2]
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Severity of Dependence Scale (SDS) Scores
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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. Higher scores indicate more severe psychological dependence on the drug being enquired about (i.e., alcohol in this study)
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Timepoint [2]
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Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
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Secondary outcome [3]
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Total Scores on the Alcohol Use Disorders Identification Test (AUDIT)
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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 was modified to ask participants to base answers on the past 3 months so that equivalent, non-overlapping periods were assessed at both baseline and the final follow-up.
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Timepoint [3]
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Baseline and 16 weeks after commencing app use
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Secondary outcome [4]
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Past-week Heavy Drinking Days (HDDs)
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Assessment method [4]
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Participants estimated the number of standard drinks of alcohol consumed on each day within the past week. Any day when they estimate they consumed at least 5 standard drinks in a day was considered an HDD.
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Timepoint [4]
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Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
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Secondary outcome [5]
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Past-Month Drinking Days
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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. 1-month and 3-month follow-up assessments will be identical to the baseline assessment.
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Timepoint [5]
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Baseline, 8 weeks after commencing app use, and 16 weeks after commencing app use
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Secondary outcome [6]
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Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments
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Assessment method [6]
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Past-week complete abstinence will be defined as zero days in the past week on which any alcohol was consumed. Predicted proportions from the linear mixed-effects model are entered using a measure type of "mean", as advised by the trial statistician, because the model produces predicted means from the data (after coding abstinence as 1 and non-abstinence as 0) after the model accounts for complexities in the data, such as the repeated measures of the data, imbalances in group sizes, and assumptions regarding error correlation, random effects, fixed effects.
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Timepoint [6]
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Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
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Secondary outcome [7]
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Proportion of Past-Month Complete Abstinence at Post-Intervention and Follow Up Assessments
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Assessment method [7]
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Participants reporting zero drinking days in the past month will be classified as past-month abstinent. Predicted proportions from the linear mixed-effects model are entered using a measure type of "mean", as advised by the trial statistician, because the model produces predicted means from the data (after coding abstinence as 1 and non-abstinence as 0) after the model accounts for complexities in the data, such as the repeated measures of the data, imbalances in group sizes, and assumptions regarding error correlation, random effects, fixed effects.
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Timepoint [7]
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Baseline, 8 weeks after commencing app use, and 16 weeks after commencing app use
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Secondary outcome [8]
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Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
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Assessment method [8]
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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 [8]
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Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, 16 weeks after commencing app use.
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Secondary outcome [9]
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Approach Bias
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Assessment method [9]
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Approach bias will be assessed within the app using an alcohol approach avoidance task. The approach avoidance task is a behavioural task designed to measure alcohol approach bias, which is the tendency to approach alcohol-related stimuli more quickly than avoiding them (relative to the same tendency for neutral stimuli). This is calculated from reaction time differences according to the formula: (RTalc-avoid - RTalc-approach) - (RTneu-avoid - RTneu-approach), where RTs are the mean reaction times for alcohol avoidance, alcohol approach, neutral stimulus avoidance, and neutral stimulus approach reactions, respectively. Thus, a positive approach bias score reflects a tendency to make an approach movement towards alcohol images more quickly than to make an avoidance, and for that tendency to be larger than the equivalent tendency for neutral images. Scores do not have specific minimum or maximum values.
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Timepoint [9]
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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
25/05/2022
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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 collaborator category [5]
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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/study/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. doi: 10.1111/acer.13439. 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
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/56/NCT05120856/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/56/NCT05120856/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05120856
Download to PDF