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Trial registered on ANZCTR

Registration number

ACTRN12620000638932

Ethics application status

Approved

Date submitted

7/05/2020

Date registered

29/05/2020

Date last updated

28/10/2021

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]

None

Universal Trial Number (UTN)

Trial acronym

SWIPE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hazardous alcohol use

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

Treatment: Devices

Comparator / control treatment

No control group - this is an open-label, single-group feasibility study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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 [1]

Primary time-point is 4 weeks after the participant downloads the app. Secondary time-points are 1, 2, and 3 weeks after downloading the app and the 1-month follow-up.

Primary outcome [2]

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]

4 weeks after the participant downloads the app.

Primary outcome [3]

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]

4 weeks after the participant download the app

Secondary outcome [1]

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]

at post-test (4 weeks after downloading the app), and at the 1-month follow-up

Secondary outcome [2]

Number of participants recruited.

Timepoint [2]

6 months after commencing recruitment.

Secondary outcome [3]

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]

1, 2, 3, and 4 weeks since commencing the app and at the 1-month follow-up

Secondary outcome [4]

Severity of psychological dependence on alcohol, as indexed by the Severity of Dependence Scale score

Timepoint [4]

4 weeks after downloading the app

Secondary outcome [5]

Craving visual analogue scale score

Timepoint [5]

immediately after the final session of ABM

Secondary outcome [6]

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]

Averaged over all sessions that occur during the 4-week intervention period

Secondary outcome [7]

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]

The 4-week intervention period

Secondary outcome [8]

Approach bias modification session durations, which will be part of the app analytical data saved and exported for each session of ABM.

Timepoint [8]

The 4-week intervention period

Secondary outcome [9]

Score on the "functionality" subscale of the user version of the Mobile Application Rating Scale.

Timepoint [9]