Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001194257
Ethics application status
Approved
Date submitted
16/07/2018
Date registered
17/07/2018
Date last updated
16/10/2019
Date data sharing statement initially provided
16/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating a smartphone app focussed on helping people reduce their drinking.
Scientific title
A randomised controlled trial of a smartphone app which uses personalised implementation intentions to reduce alcohol consumption.
Secondary ID [1] 294763 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risky drinking 307696 0
Alcohol-related harms
 307697 0
Condition category
Condition code
Public Health 306756 306756 0 0
Health promotion/education
Mental Health 307778 307778 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a smartphone app (iOS and Android compatible) that delivers a structured 4-week intervention program with the aim of reducing alcohol consumption among individuals who engage in harmful drinking. The app has an embedded follow-up 4 weeks later. The app delivers four evidence-based intervention components: consumption monitoring, consumption feedback, goal-setting, and Implementation Intentions (“If-Then Plans”).
Monitoring occurs via a daily alert that asks participants to report what type of drink they consumed on the previous day, and how much.
The feedback component, delivered within the same daily alert (and is also always available), shows a daily consumption bar graph spanning the entire intervention (indicating whether each day’s entry was above or below Australian safe drinking guidelines) and a cumulative average line graph (indicating whether the consumption average is above or below Australian safe drinking guidelines).
The goal-setting component is comprised of four goals that serve to both limit drinking times and drinking speed.
Finally, the Implementation Intention component is comprised of a guided setup that involves selecting and personalising If-Then Plans associated with each of the above goals.
Adherence to the intervention is monitored via compliance to self-reported daily drinking reports and the collection of app usage analytics in relation to practicing the implementation intentions.
The time-course of the program is as follows: Week 1 (‘Drinking as Usual’) involves consumption monitoring only (a single daily alert, as in monitoring component above); Weeks 2, 3, and 4 (‘Learning How to Cut Down’) are comprised of the full intervention (with the four key components, as outlined above); Weeks 5, 6, 7, and 8 (‘Practicing Independently’) constitute the post-intervention phase, whereby the app is mostly disabled. During this phase, participants receive a single weekly alert to remind them to engage in practicing their If-Then Plans, and during week 8 they receive a daily consumption monitoring alert. Following completion of the follow-up survey, the fully functional app is reinstated, along with some addition settings for ongoing use.
Intervention code [1] 301083 0
Treatment: Devices
Intervention code [2] 301084 0
Behaviour
Comparator / control treatment
The app group will be compared to a waitlist group. The waitlist period is for 4 weeks (duration between Pre and Post surveys), following which waitlist participants acquire the app.
Control group
Active

Outcomes
Primary outcome [1] 305745 0
Primary outcome 1: Average number of Standard Drinks consumed per drinking day over a 7-day period.
Type of data: Daily EMA consumption reports.
Timepoint [1] 305745 0
Time points: Baseline (during Week 1), Post-intervention (during Week 4).
Primary outcome [2] 305746 0
Primary outcome 2: Self-reported alcohol problems.
Type of data: Self-report questionnaire, the Alcohol Use Disorders Identification Test (AUDIT).
Timepoint [2] 305746 0
Time points: Baseline (prior to randomisation), Post-intervention (at end of week 4).
Secondary outcome [1] 346343 0
Secondary outcome 1: Number of Risky Single Occasion Drinking events (RSOD, defined as drinking more than 4 standard drinks on one occasion for males and females) over 1-week period.
Type of data: Daily EMA consumption reports.
Timepoint [1] 346343 0
Time points: Baseline (during Week 1), Post-intervention (during Week 4).
Secondary outcome [2] 346344 0
Secondary outcome 2: Number of Alcohol-Free Days (AFDs) over 1-week period.
Type of data: Daily EMA consumption reports.
Timepoint [2] 346344 0
Time points: Baseline (during Week 1), Post-intervention (during Week 4).
Secondary outcome [3] 346345 0
Secondary outcome 3: Self-reported alcohol-related consequences
Type of data: Self-report, modified 8-item version of Young Adults Alcohol Consequence Questionnaire (YAACQ).
Timepoint [3] 346345 0
Time points: Baseline (prior to randomisation), Post-intervention (at end of week 4).
Secondary outcome [4] 346346 0
Secondary outcome 4: Self-reported psychological health
Type of data: Self-report, 12-item version of the General Health Questionnaire (GHQ-12).
Timepoint [4] 346346 0
Time points: Baseline (prior to randomisation), Post-intervention (at end of week 4).
Secondary outcome [5] 346347 0
Moderator analysis 1: Baseline variables that moderate Primary outcome 1 or 2.
Type of data: Self-report item: Motivation to reducing drinking; measured with single in-app item on a visual analogue scale.
Timepoint [5] 346347 0
Timepoints: Baseline (prior to randomisation), Post-intervention (Week 4).
Secondary outcome [6] 346348 0
Moderator analysis 2: Baseline variables that moderate Primary outcome 1 or 2.
Type of data: Self-report item: Confidence in ability to reducing drinking; measured with single in-app item on a visual analogue scale.
Timepoint [6] 346348 0
Timepoints: Baseline (prior to randomisation), Post-intervention (Week 4).
Secondary outcome [7] 349411 0
Moderator analysis 3: Baseline variables that moderate Primary outcome 1 or 2.
Type of data: Self-report questionnaires: Negative Urgency, measured with 4-item subscale of the SUPPS
Timepoint [7] 349411 0
Timepoints: Baseline (prior to randomisation), Post-intervention (Week 4).
Secondary outcome [8] 349540 0
Moderator analysis 4: Baseline variables that moderate Primary outcome 1 or 2.
Type of data: Self-report questionnaires: Positive Urgency, measured with 4-item subscale of the SUPPS
Timepoint [8] 349540 0
Timepoints: Baseline (prior to randomisation), Post-intervention (Week 4).
Secondary outcome [9] 349541 0
Moderator analysis 5: Baseline variables that moderate Primary outcome 1 or 2.
Type of data: Self-report questionnaires: Lack of Perseverance, measured with 4-item subscale of the SUPPS
Timepoint [9] 349541 0
Timepoints: Baseline (prior to randomisation), Post-intervention (Week 4).
Secondary outcome [10] 349542 0
Mediator analysis: Intervention engagement variables that mediate Primary outcome 1 or 2.
Type of data: In-app composite score of:
• 3-week mean daily If-Then Booster Memorizer score.
• 3-week mean daily If-Then Booster Visualizer score.
• 3-week mean daily If-Then Plan Use score.
Timepoint [10] 349542 0
Timepoints: During active intervention (during Weeks 2, 3, and 4), and Post-intervention (Week 4).
Secondary outcome [11] 349543 0
Follow-up outcome: Follow-up scores, collapsed across both Intervention and Waitlist groups.
Type of data: Daily EMA consumption reports: Number of Standard Drinks consumed over 1-week period.
Timepoint [11] 349543 0
Time point: Baseline (prior to randomisation), Follow-up (Week 8).
Secondary outcome [12] 349544 0
Follow-up outcome: Follow-up scores, collapsed across both Intervention and Waitlist groups.
Type of data: questionnaire: AUDIT (modified 3-week version) score.
Timepoint [12] 349544 0
Time point: Baseline (prior to randomisation), Follow-up (Week 8).
Secondary outcome [13] 349545 0
Follow-up outcome: Follow-up scores, collapsed across both Intervention and Waitlist groups.
Type of data: Daily EMA consumption reports: Number of RSOD events over 1-week period.
Timepoint [13] 349545 0
Time point: Baseline (prior to randomisation), Follow-up (Week 8).
Secondary outcome [14] 349546 0
Follow-up outcome: Follow-up scores, collapsed across both Intervention and Waitlist groups.
Type of data: Daily EMA consumption reports: Number of AFDs over 1-week period.
Timepoint [14] 349546 0
Time point: Baseline (prior to randomisation), Follow-up (Week 8).

Eligibility
Key inclusion criteria
Problematic alcohol use – 5 to 10 inclusive as measured by AUDIT-C
Permanent access to iOS or Android smartphone
Express an intention to reduce or quit drinking alcohol
Between the ages of 18 - 60
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Allocation is computerised and so once baseline is completed participants are automatically allocated to treatment or waitlist group. Researcher has no control over allocation, and is not involved in communicating allocation to participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation occurs via computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multi-level modelling will be utilised to assess primary and secondary outcomes and predictors. Appropriate missing data will be imputed using multiple imputation. Power analysis showed that a final sample of 139 participants per group was required to have .8 power to detect the expected (d=.3) effect size - total sample of 278. Given the attrition rate of app-based studies we will recruit a further 25% if necessary.
We will conduct an intent to treat analysis and a per protocol analysis.
Per Protocol analysis includes participants who complete the daily report 70% of the time during the critical weeks (i.e., Week 1, Week 4, and Week 8).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/07/2018
Actual
13/07/2018
Date of last participant enrolment
Anticipated
1/12/2019
Actual
Date of last data collection
Anticipated
24/04/2020
Actual
Sample size
Target
278
Accrual to date
450
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299367 0
University
Name [1] 299367 0
Deakin University
Country [1] 299367 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 298646 0
None
Name [1] 298646 0
Address [1] 298646 0
Country [1] 298646 0
Australia
Other collaborator category [1] 280243 0
Individual
Name [1] 280243 0
Paul Liknaitzky
Address [1] 280243 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [1] 280243 0
Australia
Other collaborator category [2] 280244 0
Individual
Name [2] 280244 0
Renee O'Donnell
Address [2] 280244 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [2] 280244 0
Australia
Other collaborator category [3] 280245 0
Individual
Name [3] 280245 0
Kate Hall
Address [3] 280245 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [3] 280245 0
Australia
Other collaborator category [4] 280246 0
Individual
Name [4] 280246 0
Matthew Fuller-Tyszkiewicz
Address [4] 280246 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country [4] 280246 0
Australia
Other collaborator category [5] 280247 0
Individual
Name [5] 280247 0
Ben Richardson
Address [5] 280247 0
Cairnmiller Institute
391 Tooronga Rd
Hawthorn East VIC 3123
Country [5] 280247 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300272 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 300272 0
Ethics committee country [1] 300272 0
Australia
Date submitted for ethics approval [1] 300272 0
Approval date [1] 300272 0
23/04/2018
Ethics approval number [1] 300272 0
2016-059

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83110 0
A/Prof Petra Staiger
Address 83110 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 83110 0
Australia
Phone 83110 0
+61 3 9244 6876
Fax 83110 0
Email 83110 0
[email protected]
Contact person for public queries
Name 83111 0
Petra Staiger
Address 83111 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 83111 0
Australia
Phone 83111 0
+61 3 9244 6876
Fax 83111 0
Email 83111 0
[email protected]
Contact person for scientific queries
Name 83112 0
Petra Staiger
Address 83112 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 83112 0
Australia
Phone 83112 0
+61 3 9244 6876
Fax 83112 0
Email 83112 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.