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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 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 [1]

4 weeks after the participant downloads the app.

Primary outcome [2]

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]

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 [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]

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 [2]

The 4-week intervention period

Secondary outcome [3]

Number of participants recruited.

Timepoint [3]

6 months after commencing recruitment.

Secondary outcome [4]

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 [4]

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

Secondary outcome [5]

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

Timepoint [5]

4 weeks after commencing the intervention

Secondary outcome [6]

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

Timepoint [6]

4 weeks after downloading the app

Secondary outcome [7]

Craving Experience Scale "frequency" scale score

Timepoint [7]

4 weeks after commencing the intervention

Secondary outcome [8]

Craving visual analogue scale score

Timepoint [8]

immediately after the final session of ABM

Secondary outcome [9]

Score on the "app subjective quality" subscale of the user version of the Mobile Application Rating Scale

Timepoint [9]

4 weeks after commencing the intervention

Secondary outcome [10]

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

Timepoint [10]

The 4-week intervention period

Secondary outcome [11]

Craving Experience Scale "intensity" scale score

Timepoint [11]

4 weeks after commencing the intervention

Secondary outcome [12]

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 [12]

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

Secondary outcome [13]

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

Timepoint [13]

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

Sex

Both males and females

Can healthy volunteers participate?

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. We will also explore, using linear mixed modelling, whether other factors measured prior to commencing the intervention moderate changes in alcohol use outcomes, including motivation to change alcohol use, self-reported importance of changing alcohol use, and self-reported confidence to change alcohol use, AUDIT score, quantity and frequency of alcohol use, dependence and craving symptoms, age, and gender. 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

Completed

Date of first participant enrolment

Anticipated

1/07/2020

Actual

29/08/2020

Date of last participant enrolment

Anticipated

30/09/2020

Actual

28/02/2021

Date of last data collection

Anticipated

28/06/2021

Actual

29/04/2021

Sample size

Target

500

Accrual to date

Final

1309

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Rechabite Foundation

Address [1]

C\O Prof Robin Room
Centre for Alcohol Policy Research
La Trobe University
Kingsbury Drive
Bundoora, Victoria
3086

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Road
Clayton Victoria
3800

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash Research Office
26 Sports Walk
Monash University
Wellington Road
Clayton, VIC
3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/05/2020

Approval date [1]

29/05/2020

Ethics approval number [1]

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.
6. The reduction of drinking over the intervention period will be larger in those with more severe baseline alcohol use/problems, and also larger in those with greater motivation and confidence to reduce alcohol use.

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

www.swipe-app.com.au

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Victoria Manning

Address

Turning Point
110 Church Street
Richmond, Victoria
3121

Country

Australia

Phone

+61 3 8413 8724

Fax

victoria.manning@monash.edu

Contact person for public queries

Name

Victoria Manning

Address

Turning Point
110 Church Street
Richmond, Victoria
3121

Country

Australia

Phone

+61 3 8413 8724

Fax

victoria.manning@monash.edu

Contact person for scientific queries

Name

Victoria Manning

Address

Turning Point
110 Church Street
Richmond, Victoria
3121

Country

Australia

Phone

+61 3 8413 8724

Fax

victoria.manning@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Email	Attachment
7888	Study protocol		379786-(Uploaded-02-03-2021-13-43-00)-Study-related document.docx
7889	Informed consent form		379786-(Uploaded-07-05-2020-16-13-06)-Study-related document.docx
7890	Ethical approval	victoria.manning@monash.edu	379786-(Uploaded-02-03-2021-13-43-00)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A Personalized Approach Bias Modification Smartphone App ("SWiPE") to Reduce Alcohol Use: Open-Label Feasibility, Acceptability, and Preliminary Effectiveness Study.	2021	https://dx.doi.org/10.2196/31353

N.B. These documents automatically identified may not have been verified by the study sponsor.

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