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Trial registered on ANZCTR


Registration number
ACTRN12620000638932p
Ethics application status
Submitted, not yet approved
Date submitted
7/05/2020
Date registered
29/05/2020
Date last updated
29/05/2020
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
“SWIPE”: A Personalised brain-training app to reduce alcohol cravings and consumption
Scientific title
SWIPE: An open-label pilot feasibility study of a novel approach bias modification smartphone application to reduce alcohol use among people drinking at hazardous levels and who wish to reduce their alcohol consumption
Secondary ID [1] 301225 0
None
Universal Trial Number (UTN)
Trial acronym
SWIPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hazardous alcohol use 317383 0
Condition category
Condition code
Mental Health 315489 315489 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves delivery of alcohol approach bias modification via a smartphone app. Once participants download the app to their phone, but prior to commencing the intervention, participants will be prompted to select 6 alcohol-related pictures that represent the drinks they most frequently consume. Participants can either take and upload photographs using their phone or select pictures from a library of alcohol-related images chosen to represent a broad range of alcoholic beverages commonly consumed in Australia. Participants will then be prompted to select 6 pictures that “represent your goals and motivations”. Again, participants can either take and upload photographs or select pictures from a library of pictures representing a range of healthy activities or positive goals and sources of pleasure (including family or friends enjoying time together; financial success; employment; exercise, sports, and recreational activities; healthy foods; pets; travel and holidays) which do not contain any depiction of alcohol.

Once the participant selects their 12 pictures, they will be presented with instructions for the ABM task. Pictures (200 x 200 pixels) will be displayed with a white “frame” around them which will be in either landscape or portrait orientation. When the frame is in landscape orientation, the participant is required to swipe downwards (i.e., towards themself), which (if the movement is at least 40 pixels downward) causes the picture to expand, increasing to 600 x 600 pixels over a period of 500 milliseconds (ms), as if the participant has “pulled” the picture “towards” themselves. When the frame is in portrait orientation, the participant is instructed to swipe upwards (i.e., away from themself), which (if the movement is at least 40 pixels upwards) causes the picture to shrink until it disappears, which takes 500 ms, as if they have “pushed” it “away”. If the participant swipes (at least 40 pixels) in the wrong direction, a red “X” is displayed to inform them that they made an error. After the picture expands/shrinks to its maximum/minimum extent, there is a 250 ms inter-stimulus interval before presentation of the next picture.

Following the display of the instructions, participants complete 10 practise trials (including 5 images in portrait frames and 5 in landscape frames, in random order) to familiarise them with the task before commencing scored trials. Following the practise trials, participants will complete the first session of ABM. Each session consists of 156 trials, comprising 13 presentations of each picture. For alcohol pictures, 12 of the 13 presentations are framed in portrait orientation, and one is framed in landscape orientation. This is reversed for positive pictures, whereby 12 of the 13 presentations of each positive picture are framed in landscape orientation, while one is framed in portrait orientation. Thus, participants are supposed to push away 92.3% of alcohol images and pull 92.3% of positive images towards themselves. If participants make the incorrect response, they are informed that it was an error, but the trial is not repeated.

To increase engagement and encourage participants to respond both quickly and accurately, the task is gamified with a scoring system. Each time the participant swipes an image in the correct direction, they are awarded 10 points. Additionally, they score 'bonus points' for correct responses if their response is fast enough. If they swipe correctly and within 500 milliseconds (ms) of picture onset, they receive 30 bonus points (yielding a total of 40 points for that trial). If they swipe correctly within 500-1000 ms of picture onset they receive 20 bonus points (i.e., 30 points total). If they respond correctly within 1000-1500ms they receive 10 bonus points (i.e., 20 points total). Correct responses that are slower than 1500 ms following picture onset earn only 10 points. If they swipe an image incorrectly (i.e., swipe down for portrait or swipe up for landscape), they lose 100 points, regardless of their reaction time. Note that reaction time is recorded as the time taken to complete the swipe movement (i.e., the interval between picture display and the time at which the participant has moved their finger at least 40 pixels upwards/downwards).

Participants’ score will be displayed on the screen as they perform the task. Upon completion of the task, the final point score is displayed. At the end of these sessions, their final score for that session will be shown (and, if it not their first session, their previous personal best score will also be displayed, so they can compare their performance). On the second and subsequent sessions, participants are offered the opportunity to review the task instructions and complete the 10 practise trials, but from the second session onwards they are provided with the option to skip these steps. Participants will be prompted by the app to complete a minimum of two ABM sessions each week for four weeks, as the target number of sessions is 8 sessions over 4 weeks. App analytical data that will be saved by the app and exported for analysis will include the date and start time of each ABM session, and whether or not the session was completed. This will allow assessment of adherence to the app (e.g., number of sessions commenced each week and in total; whether any sessions were left uncompleted).
Intervention code [1] 317526 0
Behaviour
Intervention code [2] 317715 0
Treatment: Devices
Comparator / control treatment
No control group - this is an open-label, single-group feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323727 0
Number of participants recruited
Timepoint [1] 323727 0
3 months from commencing recruitment
Primary outcome [2] 323728 0
Number of sessions that the participant completes. App analytical data will include the date and start time of each session that a participant commences, and will also state whether or not the sessions was completed (i.e., responses made to all 156 trials). Thus, we can use these data to count the number of completed sessions within the 4-week intervention period.
Timepoint [2] 323728 0
4 weeks after the participant downloads the app.
Primary outcome [3] 323729 0
Proportion of participants who complete 8 sessions. App analytical data will include the date and start time of each session that a participant commences, and will also state whether or not the sessions was completed (i.e., responses made to all 156 trials). Thus, we can use these data to count the number of completed sessions within the 4-week intervention period.
Timepoint [3] 323729 0
4 weeks after the participant download the app
Secondary outcome [1] 382732 0
Number of days of alcohol use in the past 28 days.

This will be assessed using a questionnaire designed for this study. During the 4-week intervention period, participants will be prompted at weekly intervals to enter the number of standard drinks consumed each day of the past week. Thus, at the end of the 4-week period, we will be able to count the number of days where the participants entered a number higher than '0' (indicating that at least some alcohol was consumed) to derive this outcome. At the 1-month follow-up, participants will presented with another study-specific questionnaire in which they will be asked how many days they consumed alcohol in each of the 4 weeks since completing the intervention, and the sum of these 4 weeks will be used to derive this outcome for this time point.
Timepoint [1] 382732 0
at post-test (4 weeks after downloading the app), and at the 1-month follow-up
Secondary outcome [2] 382733 0
Number of days of alcohol use in the past 7 days.

During the 4 weeks of the intervention, as well as at the 1-month follow-up, participants will be prompted to fill in a study-specific questionnaire, modeled on the timeline follow-back interview method, in which they will be asked to enter the number of standard drinks they consumed on each of the 7 days of the past week. The number of days on which they enter a number larger than '0' (and therefore consumed at least some alcohol) will be this outcome.
Timepoint [2] 382733 0
1, 2, 3, and 4 weeks since commencing the app and at the 1-month follow-up
Secondary outcome [3] 382734 0
Total standard drinks consumed in the past 7 days.

During the 4 weeks of the intervention, as well as at the 1-month follow-up, participants will be prompted to fill in a study-specific questionnaire, modeled on the timeline follow-back interview method, in which they will be asked to enter the number of standard drinks they consumed on each of the 7 days of the past week. The sum of the number of standard drinks across all 7 days will be used to derive this outcome.
Timepoint [3] 382734 0
1, 2, 3, and 4 weeks since commencing the app and at the 1-month follow-up
Secondary outcome [4] 382735 0
Severity of psychological dependence on alcohol, as indexed by the Severity of Dependence Scale score
Timepoint [4] 382735 0
4 weeks after downloading the app
Secondary outcome [5] 382737 0
Craving visual analogue scale score
Timepoint [5] 382737 0
immediately after the final session of ABM
Secondary outcome [6] 382738 0
Trial error rate.

App analytical data that will be saved and exported will include, for each ABM session, the percentage of trials in which the participant made an incorrect response.
Timepoint [6] 382738 0
Averaged over all sessions that occur during the 4-week intervention period
Secondary outcome [7] 382739 0
Reaction time for responses to alcohol and non-alcohol pictures. Mean reaction times for trials on which the participant made a correct response will be saved and exported (separately for each picture type) as part of the app analytical data for each session.
Timepoint [7] 382739 0
The 4-week intervention period
Secondary outcome [8] 382740 0
Approach bias modification session durations, which will be part of the app analytical data saved and exported for each session of ABM.
Timepoint [8] 382740 0
The 4-week intervention period
Secondary outcome [9] 383116 0
Score on the "functionality" subscale of the user version of the Mobile Application Rating Scale.
Timepoint [9] 383116 0
4 weeks after commencing the intervention
Secondary outcome [10] 383117 0
Score on the "aesthetics" subscale of the user version of the Mobile Application Rating Scale
Timepoint [10] 383117 0
4 weeks after commencing the intervention
Secondary outcome [11] 383119 0
Score on the "app subjective quality" subscale of the user version of the Mobile Application Rating Scale
Timepoint [11] 383119 0
4 weeks after commencing the intervention
Secondary outcome [12] 383127 0
Craving Experience Scale "frequency" scale score
Timepoint [12] 383127 0
4 weeks after commencing the intervention
Secondary outcome [13] 383128 0
Craving Experience Scale "intensity" scale score
Timepoint [13] 383128 0
4 weeks after commencing the intervention

Eligibility
Key inclusion criteria
1. A score of at least 8 on the Alcohol Use Disorders Identification Test
2. Own an Android or Apple iOS smartphone with an Australian phone number
3. Wishes to reduce alcohol use
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No additional criteria, aside from inclusion criteria and minimum age listed above

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Feasibility and acceptability will be assessed using descriptive data, including number of participants recruited, number of sessions commenced, number of sessions completed, and means and distributions of Mobile Application Rating Scale subscale scores. Changes in alcohol consumption, craving, and SDS scores will be analysed using linear mixed modelling. To analyse whether there is a “dose-response” relationship between number of ABM sessions completed and these outcomes, we will examine the interaction term between number of sessions and time to test whether number of sessions moderates the effect of time on these outcomes. To inform refinement of task and scoring parameters for future versions of the app, we will examine rates of errors and distributions of reaction times for each image type. We will also examine the mean and distribution of session durations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305675 0
Charities/Societies/Foundations
Name [1] 305675 0
Australian Rechabite Foundation
Address [1] 305675 0
C\O Prof Robin Room
Centre for Alcohol Policy Research
La Trobe University
Kingsbury Drive
Bundoora, Victoria
3086
Country [1] 305675 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton Victoria
3800
Country
Australia
Secondary sponsor category [1] 306084 0
None
Name [1] 306084 0
Address [1] 306084 0
Country [1] 306084 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305956 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 305956 0
Monash Research Office
26 Sports Walk
Monash University
Wellington Road
Clayton, VIC
3800
Ethics committee country [1] 305956 0
Australia
Date submitted for ethics approval [1] 305956 0
07/05/2020
Approval date [1] 305956 0
Ethics approval number [1] 305956 0

Summary
Brief summary
"Approach bias modification" (ABM) is a computer-based, behavioural "brain-training" intervention that has been shown to help prevent relapse in people receiving residential treatment for alcohol use disorder (AUD). However, very few studies have tested whether ABM can be delivered as a smartphone app, and whether an ABM app can benefit heavy drinkers in the community who are not engaged in residential treatment. There have also been no studies examining whether it is useful to "personalise" ABM by allowing participants to select the stimuli used in the training task.

We have developed "SWIPE", an ABM smartphone app, in which participants are trained to avoid alcohol-related images by "pushing them away" (which causes the image to shrink and then disappear), and approach positive images by "pulling" them, causing them to enlarge, Unlike previous alcohol ABM tasks, which use a standard set of images for all participants, SWIPE is personalised. Participants are prompted to select alcohol-related and positive images that are most relevant to them to use as training stimuli before commencing training. Additionally, SWIPE is "gamified", awarding points to participants for the speed and accuracy of their response, and encouraging them to try to improve their score on subsequent training sessions.

We aim to test the feasibility and acceptability of SWIPE in people reporting hazardous alcohol use, recruited from the general community. In addition, we aim to gather data on drinking, alcohol craving, and alcohol dependence outcomes following training to assess whether these decrease after using SWIPE, since that would help determine if it is worth proceeding to a controlled trial testing its efficacy.

We hypothesise that:
1. We will recruit 500 participants within 3 months of launching the app, supporting the feasibility of this programme.
2. At least 60% of participants will complete 8 sessions of ABM, supporting its feasibility and acceptability.
3. Mean ratings of the app will be greater than 3 on each subscale of the Mobile Acceptability Rating Scale, demonstrating adequate acceptability.
4. There will be statistically significant decreases in number of standard drinks per week, number of days on which alcohol was used in the past 7 days, alcohol craving, and Severity of Dependence Scale scores at the end of the 4-week intervention, relative to pre-training scores, suggesting its potential effectiveness.
5. The more sessions of ABM that participants complete, the larger will be the reductions in alcohol drinking, craving, and dependence symptoms.

We also intend to explore participants’ reaction time and error rate data from their ABM sessions as this will inform further refinement of the app after this study is completed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102202 0
A/Prof Victoria Manning
Address 102202 0
Turning Point
110 Church Street
Richmond, Victoria
3121
Country 102202 0
Australia
Phone 102202 0
+61 3 8413 8724
Fax 102202 0
Email 102202 0
victoria.manning@monash.edu
Contact person for public queries
Name 102203 0
A/Prof Victoria Manning
Address 102203 0
Turning Point
110 Church Street
Richmond, Victoria
3121
Country 102203 0
Australia
Phone 102203 0
+61 3 8413 8724
Fax 102203 0
Email 102203 0
victoria.manning@monash.edu
Contact person for scientific queries
Name 102204 0
A/Prof Victoria Manning
Address 102204 0
Turning Point
110 Church Street
Richmond, Victoria
3121
Country 102204 0
Australia
Phone 102204 0
+61 3 8413 8724
Fax 102204 0
Email 102204 0
victoria.manning@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We assured participants that data would not be shared outside the research team because we believed that participants might be unlikely to consent if data could be distributed outside the research team.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7888 0
Study protocol
Citation [1] 7888 0
Link [1] 7888 0
Email [1] 7888 0
Other [1] 7888 0
Type [2] 7889 0
Informed consent form
Citation [2] 7889 0
Link [2] 7889 0
Email [2] 7889 0
Other [2] 7889 0
Type [3] 7890 0
Ethical approval
Citation [3] 7890 0
Link [3] 7890 0
Email [3] 7890 0
victoria.manning@monash.edu
Other [3] 7890 0
Attachment [3] 7890 0
Summary results
No Results