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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
20/05/2024

Titles & IDs
Public title
AAT-App Outpatient Trial
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
Secondary ID [1] 0 0
ADRIA045
Universal Trial Number (UTN)
Trial acronym
AAT-App
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder (AUD) 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Number of Standard Drinks Consumed Per Week at Post-Intervention and Follow-Up Assessments
Timepoint [1] 0 0
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)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Secondary outcome [2] 0 0
Change from Baseline in Alcohol Dependence Scores on the Severity of Dependence Scale (SDS) at Post-Intervention and Follow-Up Assessments
Timepoint [2] 0 0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Secondary outcome [3] 0 0
Change from Baseline in Total Scores on the Alcohol Use Disorders Identification Test (AUDIT) at 3-Month Follow-Up Assessment
Timepoint [3] 0 0
Baseline and 3-Month Follow Up
Secondary outcome [4] 0 0
Change from Baseline in Past-Week Total Heavy Drinking Days (HDD) at Post-Intervention and Follow Up Assessments
Timepoint [4] 0 0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Secondary outcome [5] 0 0
Change from Baseline in Proportion of Past-Month Drinking Days at Post-Intervention and Follow Up Assessments
Timepoint [5] 0 0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Secondary outcome [6] 0 0
Proportion of Past-Month Heavy Drinking Days
Timepoint [6] 0 0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Secondary outcome [7] 0 0
Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments
Timepoint [7] 0 0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Secondary outcome [8] 0 0
Proportion of Past-Month Complete Abstinence at Post-Intervention and Follow Up Assessments
Timepoint [8] 0 0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Secondary outcome [10] 0 0
Change from Baseline in Approach Bias at Post-Intervention
Timepoint [10] 0 0
Baseline and Post-Intervention (28 days after commencing app use)

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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2024
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Uniting Vic Tas - Coburg
Recruitment hospital [2] 0 0
Monash Health (Addiction Medicine Unit) - Dandenong
Recruitment hospital [3] 0 0
St. Vincent's Hospital Melbourne (Department of Addiction Medicine) - Fitzroy
Recruitment hospital [4] 0 0
Odyssey House Victoria - Richmond
Recruitment hospital [5] 0 0
Turning Point - Richmond
Recruitment hospital [6] 0 0
Star Health - South Melbourne
Recruitment postcode(s) [1] 0 0
3058 - Coburg
Recruitment postcode(s) [2] 0 0
3175 - Dandenong
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment postcode(s) [5] 0 0
3205 - South Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Turning Point
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
St Vincent's Hospital Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Uniting Vic Tas
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Star Health
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Odyssey House
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05120856
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.
Public notes

Contacts
Principal investigator
Name 0 0
Victoria Manning
Address 0 0
Turning Point
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05120856