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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
Number of Standard Drinks Consumed Per Week
Timepoint [1] 0 0
Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
Secondary outcome [1] 0 0
Past-Week Frequency of Alcohol Cravings (as Measured by the Craving Experience Questionnaire Frequency Scale - CEQ-F)
Timepoint [1] 0 0
Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
Secondary outcome [2] 0 0
Severity of Dependence Scale (SDS) Scores
Timepoint [2] 0 0
Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
Secondary outcome [3] 0 0
Total Scores on the Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [3] 0 0
Baseline and 16 weeks after commencing app use
Secondary outcome [4] 0 0
Past-week Heavy Drinking Days (HDDs)
Timepoint [4] 0 0
Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
Secondary outcome [5] 0 0
Past-Month Drinking Days
Timepoint [5] 0 0
Baseline, 8 weeks after commencing app use, and 16 weeks after commencing app use
Secondary outcome [6] 0 0
Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments
Timepoint [6] 0 0
Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use
Secondary outcome [7] 0 0
Proportion of Past-Month Complete Abstinence at Post-Intervention and Follow Up Assessments
Timepoint [7] 0 0
Baseline, 8 weeks after commencing app use, and 16 weeks after commencing app use
Secondary outcome [8] 0 0
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Timepoint [8] 0 0
Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, 16 weeks after commencing app use.
Secondary outcome [9] 0 0
Approach Bias
Timepoint [9] 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
25/05/2022
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


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05120856