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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

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
NA
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
Available to whom?
Reasonable requests to access individual participant data will be considered by the coordinating principal investigator
Available for what types of analyses?
How or where can data be obtained?


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