Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Titles & IDs
Public title
AAT-App Outpatient Trial
Query!
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
Query!
Secondary ID [1]
0
0
ADRIA045
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
AAT-App
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder (AUD)
0
0
Query!
Condition category
Condition code
Mental Health
0
0
0
0
Query!
Addiction
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
BEHAVIORAL
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change from Baseline in Number of Standard Drinks Consumed Per Week at Post-Intervention and Follow-Up Assessments
Query!
Assessment method [1]
0
0
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.
Query!
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)
Query!
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
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Query!
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
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Query!
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
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline and 3-Month Follow Up
Query!
Secondary outcome [4]
0
0
Change from Baseline in Past-Week Total Heavy Drinking Days (HDD) at Post-Intervention and Follow Up Assessments
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Query!
Secondary outcome [5]
0
0
Change from Baseline in Proportion of Past-Month Drinking Days at Post-Intervention and Follow Up Assessments
Query!
Assessment method [5]
0
0
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).
Query!
Timepoint [5]
0
0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Query!
Secondary outcome [6]
0
0
Proportion of Past-Month Heavy Drinking Days
Query!
Assessment method [6]
0
0
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).
Query!
Timepoint [6]
0
0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Query!
Secondary outcome [7]
0
0
Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments
Query!
Assessment method [7]
0
0
Past-week complete abstinence will be defined as zero days in the past week on which any alcohol was consumed.
Query!
Timepoint [7]
0
0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Query!
Secondary outcome [8]
0
0
Proportion of Past-Month Complete Abstinence at Post-Intervention and Follow Up Assessments
Query!
Assessment method [8]
0
0
Participants reporting zero drinking days in the past month will be classified as past-month abstinent.
Query!
Timepoint [8]
0
0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Query!
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
Query!
Assessment method [9]
0
0
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).
Query!
Timepoint [9]
0
0
Baseline, Post-Intervention (28 days after commencing app use), and both 1-Month and 3-Month Follow Ups
Query!
Secondary outcome [10]
0
0
Change from Baseline in Approach Bias at Post-Intervention
Query!
Assessment method [10]
0
0
Approach bias will be assessed within the app using an alcohol approach avoidance task.
Query!
Timepoint [10]
0
0
Baseline and Post-Intervention (28 days after commencing app use)
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
5/05/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
15/05/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
82
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Uniting Vic Tas - Coburg
Query!
Recruitment hospital [2]
0
0
Monash Health (Addiction Medicine Unit) - Dandenong
Query!
Recruitment hospital [3]
0
0
St. Vincent's Hospital Melbourne (Department of Addiction Medicine) - Fitzroy
Query!
Recruitment hospital [4]
0
0
Odyssey House Victoria - Richmond
Query!
Recruitment hospital [5]
0
0
Turning Point - Richmond
Query!
Recruitment hospital [6]
0
0
Star Health - South Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3058 - Coburg
Query!
Recruitment postcode(s) [2]
0
0
3175 - Dandenong
Query!
Recruitment postcode(s) [3]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [4]
0
0
3121 - Richmond
Query!
Recruitment postcode(s) [5]
0
0
3205 - South Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Turning Point
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Monash Health
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
St Vincent's Hospital Melbourne
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Uniting Vic Tas
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Other
Query!
Name [4]
0
0
Star Health
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Other collaborator category [5]
0
0
Other
Query!
Name [5]
0
0
Odyssey House
Query!
Address [5]
0
0
Query!
Country [5]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05120856
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Victoria Manning
Query!
Address
0
0
Turning Point
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
There is no plan to grant general public access to the dataset. Researchers interested in accessing deidentified individual-level participant data may contact the coordinating principal investigator, Victoria Manning. Granting access to other researchers to use deidentified data will require additional approval by the Saint Vincent's Hospital Melbourne Human Research Ethics Committee, and seeking these approvals will be the responsibility of the researchers seeking access to the dataset.
Supporting document/s available: Study protocol, Informed consent form (ICF)
Query!
When will data be available (start and end dates)?
Researchers interested in accessing individual participant data may contact the coordinating principal investigator after the primary outcome has been published. Note that data will only be stored for 7 years following publication of the last peer-reviewed publication arising from this study, or 7 years after the final report to the ethics committee, or 7 years after final reporting of outcomes on the clinical trials registry, whichever occurs latest. After this 7 year retention period, individual participant data may not be available.
Query!
Available to whom?
Reasonable requests to access individual participant data will be considered by the coordinating principal investigator
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05120856