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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04923256




Registration number
NCT04923256
Ethics application status
Date submitted
11/05/2021
Date registered
11/06/2021

Titles & IDs
Public title
AAT-APP+: A Novel Brain-training App to Reduce Drinking
Scientific title
AAT-APP+: A Pilot RCT of a Novel Smart-phone App to Reduce Alcohol Consumption Among Middle to Older Adults in the Eastern Health Community
Secondary ID [1] 0 0
73140
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - AAT-APP: A novel smart-phone approach-avoidance bias modification intervention
BEHAVIORAL - Sham training control

Experimental: Experimental: Approach Bias Modification - Participants will complete 2 x 5-7 min training sessions of approach bias modification for the period of four weeks

Active comparator: Control: Minimal intervention - Participants will complete a standardised alcohol approach-avoidance training task (AAT) on a weekly basis for four weeks.


BEHAVIORAL: AAT-APP: A novel smart-phone approach-avoidance bias modification intervention
Participants allocated to the intervention group will be required to upload photos of drinks they wish to avoid, as well as activities they wish to engage in more, and be trained to avoid and approach by repeatedly 'swiping' images away from and towards themselves, respectively.

BEHAVIORAL: Sham training control
Complete an AAT on a weekly basis for four weeks
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in number of standard drinks past week
Timepoint [1] 0 0
Change from baseline standard drinks at 4-weeks
Secondary outcome [1] 0 0
Change in number of drinking days past week
Timepoint [1] 0 0
Change from baseline drinking days at 4-weeks
Secondary outcome [2] 0 0
Change in number of standard drinks consumed in the past week throughout the 4-week training program
Timepoint [2] 0 0
Change from baseline standard drinks consumed in the week prior to training compared to each week of training (i.e. week 1, week 2, week 3).
Secondary outcome [3] 0 0
Change in number of drinking days past week throughout the 4-week training program
Timepoint [3] 0 0
Change from baseline number of drinking days in the week prior to training compared to each week of training (i.e. week 1, week 2, week 3).
Secondary outcome [4] 0 0
Change in number of drinking days at follow up
Timepoint [4] 0 0
Change from baseline number of drinking days at 8-weeks
Secondary outcome [5] 0 0
Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency)
Timepoint [5] 0 0
Change from baseline craving frequency at 4-weeks
Secondary outcome [6] 0 0
Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency, Follow up)
Timepoint [6] 0 0
Change from baseline craving frequency at 8-weeks
Secondary outcome [7] 0 0
Approach-avoidance behaviours (alcohol approach avoidance questionnaire)
Timepoint [7] 0 0
Change from baseline approach-avoidance behaviours at 4-weeks
Secondary outcome [8] 0 0
Approach-avoidance behaviours (alcohol approach avoidance questionnaire) at follow up
Timepoint [8] 0 0
Change from baseline approach-avoidance behaviours at 8-weeks
Secondary outcome [9] 0 0
Approach-avoidance behaviours (approach avoidance task)
Timepoint [9] 0 0
Change in alcohol approach/avoidance from baseline at 4-weeks
Secondary outcome [10] 0 0
Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire
Timepoint [10] 0 0
Change in quality of life from baseline at 4-weeks
Secondary outcome [11] 0 0
Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire at follow up
Timepoint [11] 0 0
Change in quality of life from baseline at 8-weeks
Secondary outcome [12] 0 0
Change in subjective cognitive concerns
Timepoint [12] 0 0
Change from baseline in subjective cognitive concerns at 4-weeks
Secondary outcome [13] 0 0
Change in subjective cognitive concerns at follow up
Timepoint [13] 0 0
Change from baseline in subjective cognitive concerns at 8-weeks
Secondary outcome [14] 0 0
Change in number of standard drinks at follow up
Timepoint [14] 0 0
Change from baseline in number of drinking days at 8 weeks
Secondary outcome [15] 0 0
Change in severity of alcohol dependence, as measured by the Severity of Dependence Scale
Timepoint [15] 0 0
Change in severity of alcohol dependence at 4-weeks
Secondary outcome [16] 0 0
Change in severity of alcohol dependence (SDS) at follow up
Timepoint [16] 0 0
Change in severity of alcohol dependence at 8-weeks

Eligibility
Key inclusion criteria
* Adults aged 55+ years
* Score 8 or higher on the Alcohol Use Disorders Identification Test (indicates 'hazardous' levels of alcohol use).
* Access to an Android or Apple smart phone and Australian contact number
* Wish to reduce their drinking
* Live within the Eastern Health Primary and Secondary Catchment (see map below)
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Under age 55
* Not concerned about their drinking
* Do not wish to reduce their alcohol use in the next 4-6 weeks
* Do not reside with the appropriate catchment will be excluded.
* Experiencing severe alcohol problems likely to need professional treatment (i.e. presence of withdrawal symptoms in the past year)

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
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Turning Point - Richmond
Recruitment postcode(s) [1] 0 0
3121 - Richmond

Funding & Sponsors
Primary sponsor type
Other
Name
Turning Point
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Eastern Health
Address [2] 0 0
Country [2] 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, PhD
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
Victoria Manning, PhD
Address 0 0
Country 0 0
Phone 0 0
+61384138724
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
A layman summary of the research findings will be made available on the Turning Point website. Participants are told in the explanatory statement that if they would like to be informed of the research findings directly, they will need to contact the researchers via email. Should participants request results of research, this will be in aggregate form.


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/NCT04923256