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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04923256
Registration number
NCT04923256
Ethics application status
Date submitted
11/05/2021
Date registered
11/06/2021
Date last updated
7/07/2022
Titles & IDs
Public title
AAT-APP+: A Novel Brain-training App to Reduce Drinking
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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
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Secondary ID [1]
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73140
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder
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Condition category
Condition code
Mental Health
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - AAT-APP: A novel smart-phone approach-avoidance bias modification intervention
Behaviour - 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.
Behaviour: 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.
Behaviour: Sham training control
Complete an AAT on a weekly basis for four weeks
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in number of standard drinks past week
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Assessment method [1]
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Change from baseline in number of standard drinks at 4-weeks
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Timepoint [1]
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Change from baseline standard drinks at 4-weeks
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Secondary outcome [1]
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Change in number of drinking days past week
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Assessment method [1]
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Change from baseline in number of drinking days at 4-weeks
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Timepoint [1]
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Change from baseline drinking days at 4-weeks
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Secondary outcome [2]
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Change in number of standard drinks consumed in the past week throughout the 4-week training program
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Assessment method [2]
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Change from baseline in number of standard drinks at the end of each week of training (i.e. week 1, week 2, week 3)
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Timepoint [2]
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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).
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Secondary outcome [3]
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Change in number of drinking days past week throughout the 4-week training program
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Assessment method [3]
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Change from baseline in the number of drinking days at the end of each week of training (i.e. week 1, week 2, week 3)
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Timepoint [3]
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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).
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Secondary outcome [4]
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Change in number of drinking days at follow up
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Assessment method [4]
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Change from baseline in the number of drinking days at 8-weeks
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Timepoint [4]
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Change from baseline number of drinking days at 8-weeks
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Secondary outcome [5]
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Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency)
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Assessment method [5]
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Change from baseline craving, as measured by the Craving Experience Questionnaire, at 4-weeks. The Craving Experience Questionnaire - frequency consists of an 11-point visual analogue scale, anchored 0 = not at all, to 10 = extremely/constantly, assessing craving frequency, whereby higher scores are suggestive of greater craving frequency
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Timepoint [5]
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Change from baseline craving frequency at 4-weeks
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Secondary outcome [6]
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Craving Frequency Score (as measured by the Craving Experience Questionnaire, Frequency, Follow up)
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Assessment method [6]
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Change from baseline craving, as measured by the Craving Experience Questionnaire, at 8-weeks. The Craving Experience Questionnaire - frequency consists of an 11-point visual analogue scale, anchored 0 = not at all, to 10 = extremely/constantly, assessing craving frequency, whereby higher scores are suggestive of greater craving frequency
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Timepoint [6]
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Change from baseline craving frequency at 8-weeks
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Secondary outcome [7]
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Approach-avoidance behaviours (alcohol approach avoidance questionnaire)
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Assessment method [7]
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Change from baseline in self-report of approach and avoidance towards alcohol, as measured by the alcohol approach avoidance questionnaire, at 4-weeks. This is a 20-item self report measure with two primary dimensions of alcohol craving (i.e. approach and avoidance), where higher scores are suggestive of greater approach or avoidance behaviours (rated on a 9-point scale, 0 = not at all, 8 = very strongly).
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Timepoint [7]
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Change from baseline approach-avoidance behaviours at 4-weeks
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Secondary outcome [8]
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Approach-avoidance behaviours (alcohol approach avoidance questionnaire) at follow up
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Assessment method [8]
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Change from baseline in self-report of approach and avoidance towards alcohol, as measured by the alcohol approach avoidance questionnaire, at 8-weeks. This is a 20-item self report measure with two primary dimensions of alcohol craving (i.e. approach and avoidance), where higher scores are suggestive of greater approach or avoidance behaviours (rated on a 9-point scale, 0 = not at all, 8 = very strongly).
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Timepoint [8]
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Change from baseline approach-avoidance behaviours at 8-weeks
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Secondary outcome [9]
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Approach-avoidance behaviours (approach avoidance task)
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Assessment method [9]
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Change in alcohol approach/avoidance behaviours from baseline at 4-weeks, as calculated by([reaction time for pushing alcohol stimuli] - [reaction time for pulling alcohol related stimuli]) - ([reaction time for pushing neutral objects] - [reaction time for pulling neutral objects]). Higher positive values indicate a tendency to approach alcohol faster (i.e. faster reaction times for pulling as opposed to pushing), whereas negative values indicate a tendency to avoid alcohol (i.e. slower reactions times for pulling compared to pushing alcohol).
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Timepoint [9]
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Change in alcohol approach/avoidance from baseline at 4-weeks
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Secondary outcome [10]
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Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire
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Assessment method [10]
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Change in self report of quality of life from baseline, as measured by the quality of life items from the Australian Treatment Outcomes Profile, at 4-weeks. This is a score ranging from 0-10, whereby higher scores are indicative of greater quality of life.
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Timepoint [10]
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Change in quality of life from baseline at 4-weeks
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Secondary outcome [11]
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Change in quality of life, as measured by the Australian Treatment Outcomes Profile Questionnaire at follow up
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Assessment method [11]
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Change in self report of quality of life from baseline, as measured by the quality of life items from the Australian Treatment Outcomes Profile, at 8-weeks. This is a score ranging from 0-10, whereby higher scores are indicative of greater quality of life.
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Timepoint [11]
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Change in quality of life from baseline at 8-weeks
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Secondary outcome [12]
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Change in subjective cognitive concerns
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Assessment method [12]
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Change from baseline in subjective ratings of cognitive concerns, as measured by responses to the question "How concerned are you about changes in your thinking, attention, or memory skills", at 4 weeks. Participants will respond on a 5-point visual analogue scale ranging from 0 = not at all to 5 = extremely concerned, whereby higher scores indicate a greater degree of concern in relation to cognition
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Timepoint [12]
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Change from baseline in subjective cognitive concerns at 4-weeks
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Secondary outcome [13]
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Change in subjective cognitive concerns at follow up
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Assessment method [13]
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Change from baseline in subjective ratings of cognitive concerns, as measured by responses to the question "How concerned are you about changes in your thinking, attention, or memory skills", at 8 weeks. Participants will respond on a 5-point visual analogue scale ranging from 0 = not at all to 5 = extremely concerned, whereby higher scores indicate a greater degree of concern in relation to cognition
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Timepoint [13]
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Change from baseline in subjective cognitive concerns at 8-weeks
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Secondary outcome [14]
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Change in number of standard drinks at follow up
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Assessment method [14]
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Change from baseline in number of drinking days at 8 weeks
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Timepoint [14]
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Change from baseline in number of drinking days at 8 weeks
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Secondary outcome [15]
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Change in severity of alcohol dependence, as measured by the Severity of Dependence Scale
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Assessment method [15]
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Change from baseline in severity of alcohol dependence, as measured by the Severity of Dependence Scale, at 4 weeks. Participants respond to five items on a 4-point scale (each scored from 0-3), with total scores ranging from 0-15 where higher scores indicate greater severity of alcohol dependence.
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Timepoint [15]
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Change in severity of alcohol dependence at 4-weeks
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Secondary outcome [16]
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Change in severity of alcohol dependence (SDS) at follow up
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Assessment method [16]
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Change from baseline in severity of alcohol dependence, as measured by the Severity of Dependence Scale, at 8-weeks. Participants respond to five items on a 4-point scale (each scored from 0-3), with total scores ranging from 0-15 where higher scores indicate greater severity of alcohol dependence.
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Timepoint [16]
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Change in severity of alcohol dependence at 8-weeks
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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)
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2023
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Turning Point - Richmond
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Recruitment postcode(s) [1]
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3121 - Richmond
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Funding & Sponsors
Primary sponsor type
Other
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Name
Turning Point
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Monash University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Eastern Health
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will explore the feasibility, acceptability, and preliminary effectiveness of a
smart phone delivered form of cognitive training intervention (Approach Bias Modification
(ABM)) in a non-clinical community sample of middle to older adults (>55 years) reporting
hazardous alcohol use in a pilot randomised controlled trial (RCT). This app is called
AAT-APP+
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04923256
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Victoria Manning, PhD
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Address
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Turning Point
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Victoria Manning, PhD
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Address
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Country
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Phone
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+61384138724
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04923256
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