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Trial registered on ANZCTR


Registration number
ACTRN12622001245785
Ethics application status
Approved
Date submitted
7/07/2022
Date registered
15/09/2022
Date last updated
21/07/2024
Date data sharing statement initially provided
15/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
AAT-App Rehabilitation Trial: The effect of smartphone-delivered cognitive training on relapse and treatment re-admission among patients leaving residential alcohol treatment.
Scientific title
The AAT-App Rehabilitation trial: A randomised controlled trial testing the effect of a novel cognitive bias modification smartphone application on alcohol use and craving among clients exiting rehabilitation treatment for alcohol use disorder.
Secondary ID [1] 303027 0
Nil known
Universal Trial Number (UTN)
U1111-1278-9253
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use disorder 326540 0
Condition category
Condition code
Mental Health 323801 323801 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with the smartphone application "AAT-App". When they first open AAT-App and enter a unique access code provided to them by the researchers, the app will automatically randomise them to either the active intervention condition or the control condition. Condition-specific instructions will be displayed in the app prior to participants commencing the intervention.

In both conditions, participants will receive weekly notifications reminding them to self-report their alcohol use and complete a "brain-training" task during a 4-week intervention period. In the active condition, this task involves a type of "cognitive bias modification" (CBM) training intended to reduce impulses to seek alcohol. This task involves responding to alcohol-related and non-alcohol-related images with upward or downward "swiping" responses based on the orientation of a frame displayed around the image.

In both conditions, the each session lasts approximately 3-5 minutes and can be completed by the participant at a time and place convenient to them. The exact number of sessions participants will be encouraged to complete over the 4-week intervention period varies according to condition, and therefore will only be publicly-revealed (by attaching the full protocol to this registration) after completion of data collection, to prevent unblinding of participants. However, participants in both conditions will be asked to complete at least 5 sessions over the 4-week intervention period.

Back-end app user metrics automatically exported to a Google Firebase database, including data regarding number of sessions commenced and number of sessions completed, will be used to monitor intervention adherence.
Intervention code [1] 323716 0
Behaviour
Intervention code [2] 323717 0
Treatment: Other
Comparator / control treatment
The control condition also involves a weekly cognitive task that involves similar responses to a similar set of images, but which is designed only to measure, rather than modify, the targeted cognitive bias. Like the intervention condition, the control condition also involves weekly self-reporting of alcohol use in the app.
Control group
Placebo

Outcomes
Primary outcome [1] 331574 0
Proportion of participants reporting past-month abstinence from alcohol (i.e., no alcohol consumption within the past 28 days). At the post-intervention, 4-week, and 12-week follow-ups, this will be measured using an in-app questionnaire designed for this programme of research based on the timeline follow-back method for assessing alcohol use. At the 6-month follow-up, this will be interviewer-administered by phone, as the app does not have an automated 6-month follow-up notification function.
Timepoint [1] 331574 0
12 weeks after the end of the intervention period (primary time-point).

Additional timepoints: post-intervention (i.e., at the end of the 4-week intervention period); 4 weeks after the end of the intervention period; 6 months after the end of the intervention period.
Secondary outcome [1] 410335 0
Alcohol approach bias, as measured by an approach avoidance task (AAT) programmed into the app.
Timepoint [1] 410335 0
post-intervention (end of the 4-week intervention period)
Secondary outcome [2] 410336 0
Severity of Dependence Scale scores for alcohol
Timepoint [2] 410336 0
post-intervention, 4-week follow-up, and 12-week follow-up
Secondary outcome [3] 410337 0
Alcohol craving intensity, as measured by a single-item visual analogue scale (quantified as a score ranging from 0-100)
Timepoint [3] 410337 0
Before and after each CBM/control training session
Secondary outcome [4] 410340 0
Frequency of alcohol craving, as measured by Craving Experience Questionnaire - Frequency scale (CEQ-F) total scores
Timepoint [4] 410340 0
post-intervention, 4-week follow-up, 12-week follow-up, 6-month follow-up
Secondary outcome [5] 410341 0
CEQ-F "Intensity" subscale scores, which measures the frequency of strong desires and urges to consume alcohol.
Timepoint [5] 410341 0
post-intervention, 4-week follow-up, 12-week follow-up, 6-month follow-up
Secondary outcome [6] 410342 0
CEQ-F "Imagery" subscale scores, which measures the frequency with which one imagines the sensory properties of alcoholic beverages (e.g., how often one thinks about what the drink looks like, tastes like, smells like, or feels like to drink).
Timepoint [6] 410342 0
post-intervention, 4-week follow-up, 12-week follow-up, 6-month follow-up
Secondary outcome [7] 410343 0
CEQ-F "Intrusiveness" subscale scores, which measures the frequency of mentally intrusive thoughts of alcohol that interfere with one's thought processes or make it difficult to concentrate or think about other things.
Timepoint [7] 410343 0
post-intervention, 4-week follow-up, 12-week follow-up, 6-month follow-up
Secondary outcome [8] 410357 0
Depression score from the Depression, Anxiety, and Stress Scale (21-item version; DASS-21)
Timepoint [8] 410357 0
post-intervention, 4-week follow-up, and 12-week follow-up
Secondary outcome [9] 410358 0
Anxiety score from the DASS-21
Timepoint [9] 410358 0
post-intervention, 4-week follow-up, and 12-week follow-up
Secondary outcome [10] 410359 0
Stress score from the DASS-21
Timepoint [10] 410359 0
post-intervention, 4-week follow-up, and 12-week follow-up
Secondary outcome [11] 410363 0
number of past-week drinking days (i.e., days on which any alcohol was consumed), as self-reported in the app (or assessed by timeline follow-back interview at 6-month follow-up)
Timepoint [11] 410363 0
1 week into the intervention period, 2 weeks into the intervention period, 3 weeks into the intervention period, post-intervention, each of the 4 weeks preceding the 4-week follow-up (i.e., 3 weeks prior to 4-week follow-up, 2 weeks prior to 4-week follow-up, 1 week prior to 4-week follow-up, at the time of the 4-week follow-up), 12-week follow-up, 6-month follow-up.
Secondary outcome [12] 410413 0
number of past-month drinking days, as assessed by:
- self-report in the app at post-intervention, 4-week follow-up, and 12-week follow-up
- interviewer-administered timeline follow-back administered over the phone at the 6-month follow-up
Timepoint [12] 410413 0
post-intervention, 4-week follow-up, 12-week follow-up, 6-month follow-up
Secondary outcome [13] 410414 0
past-week heavy drinking days (i.e., number of days on which 5 or more standard drinks were consumed), as assessed by:
- self-report in the app at post-intervention, 4-week follow-up, and 12-week follow-up. .If differences are found between groups at the post-intervention time-point, additional exploratory analyses will also use self-report data from 1 week, 2 weeks, and 3 weeks into the intervention period.
- interviewer-administered timeline follow-back administered over the phone at the 6-month follow-up
Timepoint [13] 410414 0
1 week into the intervention period, 2 weeks into the intervention period, 3 weeks into the intervention period, post-intervention, 4-week follow-up, 12-week follow-up, 6-month follow-up.
Secondary outcome [14] 410415 0
past week standard drinks consumed as assessed by:
- self-report in the app at post-intervention, 4-week follow-up, and 12-week follow-up. If differences are found between groups at the post-intervention time-point, additional exploratory analyses will also use self-report data from 1 week, 2 weeks, and 3 weeks into the intervention period.
- interviewer-administered timeline follow-back administered over the phone at the 6-month follow-up
Timepoint [14] 410415 0
1 week into the intervention period, 2 weeks into the intervention period, 3 weeks into the intervention period, post-intervention, 4-week follow-up, 12-week follow-up, 6-month follow-up.
Secondary outcome [15] 410427 0
Number of weeks to first lapse (i.e., first week that any alcohol is consumed, according to self-report in the app, over the intervention and 4-week follow-up period)
Timepoint [15] 410427 0
4-week follow-up (using data from the 8 weeks assessed over the intervention and 4-week follow-up period for survival analysis)
Secondary outcome [16] 410428 0
Alcohol Use Disorder Identification Test (AUDIT) total score
Timepoint [16] 410428 0
12-week follow-up (12 weeks after the end of the intervention period), 6-month follow-up (6 months after the end of the intervention period).
Secondary outcome [17] 410429 0
AUDIT consumption subscale (AUDIT-C) score
Timepoint [17] 410429 0
12-week follow-up (12 weeks after the end of the intervention period), 6-month follow-up (6 months after the end of the intervention period).
Secondary outcome [18] 410430 0
Presence of any alcohol use disorder, as indexed by the Structured Clinical Interview for DSM-5 (SCID-5)
Timepoint [18] 410430 0
6-months following the end of the intervention period
Secondary outcome [19] 410431 0
presence of any emergency department attendance, or readmission to residential or inpatient hospital, substance use withdrawal, rehabilitation treatment, as assessed by a health service use questionnaire designed for this study which will be interviewer-administered by telephone.
Timepoint [19] 410431 0
6-months following the end of the intervention period
Secondary outcome [20] 410432 0
Time to first readmission to residential/inpatient treatment (for survival analysis), which will be recorded in the health service use questionnaire designed for this study which will be interviewer-administered by telephone.
Timepoint [20] 410432 0
6-months following the end of the intervention period
Secondary outcome [21] 410433 0
Participant's guess regarding which condition they were randomised to (i.e., blinding check), which a researcher will ask them to make as part of the telephone-administered 6-month follow-up.
Timepoint [21] 410433 0
6-months following the end of the intervention period
Secondary outcome [22] 411627 0
Self-rated psychological health (rating a scale from 0-10 for a single item from the Australian Treatment Outcome Profile (ATOP))
Timepoint [22] 411627 0
post-intervention, 4-week follow-up, 12-week follow-up, 6-month follow-up
Secondary outcome [23] 411628 0
Self-rated physical health (0-10 rating on single item from the ATOP)
Timepoint [23] 411628 0
post-intervention, 4-week follow-up, 12-week follow-up, 6-month follow-up.
Secondary outcome [24] 411629 0
Self-rated quality of life (0-10 rating on ATOP item)
Timepoint [24] 411629 0
post-intervention, 4-week follow-up, 12-week follow-up, 6-month follow-up
Secondary outcome [25] 411630 0
Number of days participation in paid employment in the past 4 weeks, as assessed by:
- A question in a Qualtrics Plus questionnaire that the app will prompt participants to complete at the 12-week follow-up.
- An interviewer-administered question in the telephone-administered 6-month follow-up
Timepoint [25] 411630 0
12-week follow-up (12 weeks after the end of the intervention period), 6-month follow-up (6 months after the end of the intervention period).
Secondary outcome [26] 411649 0
Subjective hedonic capacity, as assessed by the Snaith-Hamilton Pleasure Scale (SHAPS)
Timepoint [26] 411649 0
post-intervention, 4-week follow-up, and 12-week follow-up

Eligibility
Key inclusion criteria
- Own an Android or iOS smartphone with an Australian mobile number
- Be currently receiving residential rehabilitation/stabilisation treatment for alcohol use disorder (AUD)
- Meet at least 4 criteria for AUD within the past 6 months, as assessed by the AUD module of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition - Research Version (SCID-5-RV)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Planning to transfer to longer-term residential rehabilitation treatment upon discharge
- Too cognitively or psychiatrically impaired to provide informed consent or safely participate, according to the screening clinician's judgment

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)
The app developers will provide an unblinded member of the research team with two lists of app access codes, one which directs participants to the intervention version, and the other which directs them to the minimal version of the AAT-App. Using these lists and the randomisation sequence, the unblinded researcher will generate a separate spreadsheet of access codes for each site (based on the site-stratified randomisation sequence - see below). Researchers will send these codes to participants as they are recruited from each respective site. Researchers involved in recruitment will only have access to a spreadsheet displaying a single list of codes in the order in which they are to be sent to participants at each respective site, while the randomisation sequence will be stored in a password-protected file provided to the trial statistician and the unblinded research officer. Neither the randomisation file nor its password will be provided to any staff involved in recruitment or in pursuing follow-ups or quantitative data management until all data analysis is complete. Participants will not be provided with information regarding the ways in which the 2 conditions differ, to minimise the likelihood of them being unblinded to their allocated condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Five computer-generated randomisation sequences (one for each recruitment site) will be produced by a research officer who is not otherwise involved in recruitment or data collection, processing, or analysis, using a 1:1 allocation ratio, based on blocks of variable size (ranging from 2-4). As such, randomisation will be stratified by site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The target sample size was determined based on practical considerations (likely recruitment rate, time available for recruitment), as there was little prior basis to estimate likely effect size of a personalised ApBM smartphone app in people leaving residential rehabilitation. Nevertheless, a power calculation was conducted in GPower 3.1.9.2 based on past-month abstinence rates at the 3-month follow-up in our recent trial of delivering ApBM during withdrawal treatment, which were 21.6% in controls and 34.7% in participants randomised to ApBM. Assuming a similar effect size in the present trial, a sample of 300 would provide 68% likelihood of detecting a significant difference, which is sub-optimal. Moreover, it is tenuous to assume that the effect size from our previous trial will generalise to the current trial, which differs in terms of the method and timing of intervention delivery as well as the setting (where rehabilitation clients are likely to show generally higher rates of abstinence than withdrawal clients, which may reduce statistical power). Thus, if recruitment proceeds quickly enough, we will aim to recruit more than 300 participants, to allow for increased statistical power.

Statistical significance will be ascertained using an alpha value of .05. Any participants who commenced at least 1 session of ApBM (if in the ApBM condition) or AAT (if in the minimal control condition) will be included in the analysis set.

Given that participants at the Wyndham recruitment site may have already received ApBM as part of standard care during residential treatment, site effects will be checked before data analyses and there will be consideration of either conducting additional sensitivity analysis without Wyndham participants or removing Wyndham participants from the primary analysis if there seem to be different effects at that site.

For the primary outcome, a Generalised Linear Mixed Model (GLMM) for binary outcome variable will be applied to examine the proportions of reported complete past-month abstinence between groups at post-intervention, 1-month follow-up, 3-month follow-up, and 6-month follow-up. Planned Pearson’s chi-squared analysis will compare groups at the primary end-point (3-month follow-up) and will also be used at other end-points if the GLMM suggests a significant overall effect.

GLMM will be used to compare changes in continuous secondary outcome variables (AUDIT, CEQ-F, SDS, DASS-21, ATOP items, SHAPS, approach bias) between groups across time points. In analyses of CEQ-F (and its subscales) and ATOP items there will be 5 levels of time (baseline, post-intervention, 1-month, 3-month, and 6-month follow-ups). In analyses of SDS, SHAPS, and DASS-21, there will be 4 levels of time (baseline, post-intervention, 1-month, and 3-month follow-ups). In analyses of AUDIT (and AUDIT-C) scores, there will be 3 levels of time (baseline, 3-month and 6-month follow-ups). Approach bias analyses will use 2 levels of time (baseline and post-intervention). GLMMs will also be used to compare change in mean alcohol use (i.e., mean standard drinks consumed per week, mean past-week drinking days, mean past-week heavy drinking days) between groups across 5 time points (baseline, post-intervention, 1-month follow-up, 3-month follow-up, 6-month follow-up). This model will test the main effects of time and group and the group x time interaction. Planned follow-up comparisons between groups at post-intervention, 1-month follow-up, 3-month follow-up, and 6-month follow-up time-points will be conducted using t-tests. If a difference between groups is found post-intervention, a secondary GLMM analysis of difference between groups in change in weekly standard drinks during the intervention period (i.e., 5 levels of time: baseline, week 1, week 2, week 3, post-intervention) will be conducted to examine how quickly differences between groups emerge, with t-tests used to compare groups at week 1, 2, 3, and post-intervention time-points. GLMMs will also be used to compare changes in past-month drinking days across 5 time points (baseline, post-intervention, 1-month, 3-month, and 6-month follow-ups).

Pearson’s chi-square tests will be used to compare proportions of participants who meet criteria for AUD at the 6-month follow-up. Time to first lapse and time to first readmission will be compared between groups using Cox regression analyses. Subjective ratings regarding AAT-App’s effect on drinking and cravings will be explored within each group separately using descriptive data (e.g., mean, median, quartile cut-offs, percentages scoring above 3) to quantify typical ratings and proportions of participants providing favourable ratings.

As the method of administering the AAT is novel, we will also examine the psychometric properties of AAT. The internal consistency of the AAT will be calculated by separately calculating Cronbach's alpha for the alcohol approach bias items and the positive approach bias items, following the method reported by Kersbergen, Woud and Field (2015). As such, we will calculate difference scores between each nth "swipe-up alcohol" trial and each nth "swipe-down alcohol" trial, deriving 20 difference scores for alcohol images. The same process will be used to derive difference scores for the 20 neutral images. Bootstrapping will be used to calculate 95% confidence intervals for Cronbach's alpha values. Test-retest reliability of alcohol approach bias and positive approach bias scores will be assessed in the control group by testing intraclass correlation between scores from their first 2 AAT assessments (baseline and week 1). Exploratory analyses will also test Pearson’s correlations between baseline alcohol approach bias scores and scores on baseline measures of alcohol craving (CEQ-F scores; pre-session VAS craving scores) and dependence severity (SDS; AUDIT).

Qualitative interview transcripts will be subjected to a thematic qualitative analysis in order to identify underlying themes and patterns within each respondent’s discourse. Thematic analysis will proceed according to the six stage process described by Braun and Clark (2006):
1 Familiarisation with the data: Reading and re-reading transcripts, noting initial ideas.
2 Coding: Deriving codes which label important features of the data that might be relevant to answering research questions. Then systematically attributing meaning throughout the dataset by identifying chunks of text with similar meanings and labelling them with corresponding codes.
3 Generating initial themes: Examining codes and collated data for broader patterns of meaning, using codes as building blocks to construct candidate themes (and promoting a code to a theme where appropriate), then collating data for each candidate theme to be “tested” in relation to research question or overall dataset.
4 Reviewing themes, checking them against the dataset to determine whether they tell a convincing story of the data that addresses the research questions; splitting, combining, and/or discarding themes as appropriate.
5 Defining and naming themes: Developing a detailed analysis of each theme, determining the ‘story’ of each.
6 Writing the manuscript: Weaving analytic narrative and data extracts, contextualising the analysis in relation to existing literature, remaining open to revising themes even at this stage.
The coding process will be primarily conducted by two researchers, and a third researcher will oversee and verify coding decisions in order to ensure agreement and consistency throughout the process. The qualitative data analysis software NVivo 12 will be used to facilitate qualitative data analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
28/11/2022
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
300
Accrual to date
113
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22491 0
The Melbourne Clinic - Richmond
Recruitment hospital [2] 22493 0
Albert Road Clinic - Melbourne
Recruitment hospital [3] 22509 0
Wyndham Hospital - Wyndham
Recruitment hospital [4] 22510 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 37726 0
3121 - Richmond
Recruitment postcode(s) [2] 37728 0
3004 - Melbourne
Recruitment postcode(s) [3] 37749 0
6740 - Wyndham
Recruitment postcode(s) [4] 37750 0
3128 - Box Hill
Recruitment postcode(s) [5] 38042 0
3442 - Woodend

Funding & Sponsors
Funding source category [1] 311622 0
Charities/Societies/Foundations
Name [1] 311622 0
HCF Research Foundation Ltd
Country [1] 311622 0
Australia
Primary sponsor type
University
Name
Monash University
Address
1-131 Wellington Road, Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 313057 0
None
Name [1] 313057 0
Address [1] 313057 0
Country [1] 313057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307518 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 307518 0
Ethics committee country [1] 307518 0
Australia
Date submitted for ethics approval [1] 307518 0
01/08/2022
Approval date [1] 307518 0
14/09/2022
Ethics approval number [1] 307518 0
E22-007-87504
Ethics committee name [2] 311234 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 311234 0
Ethics committee country [2] 311234 0
Australia
Date submitted for ethics approval [2] 311234 0
14/09/2022
Approval date [2] 311234 0
14/09/2022
Ethics approval number [2] 311234 0
35421
Ethics committee name [3] 311235 0
The Melbourne Clinic Human Research Ethics Committee
Ethics committee address [3] 311235 0
Ethics committee country [3] 311235 0
Australia
Date submitted for ethics approval [3] 311235 0
14/09/2022
Approval date [3] 311235 0
14/11/2022
Ethics approval number [3] 311235 0
351

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

Contacts
Principal investigator
Name 107526 0
A/Prof Victoria Manning
Address 107526 0
Turning Point
110 Church Street
Richmond, VIC 3121
Country 107526 0
Australia
Phone 107526 0
+61 428 337 961
Fax 107526 0
Email 107526 0
victoria.manning@monash.edu
Contact person for public queries
Name 107527 0
Victoria Manning
Address 107527 0
Turning Point
110 Church Street
Richmond, VIC 3121
Country 107527 0
Australia
Phone 107527 0
+61 428 337 961
Fax 107527 0
Email 107527 0
victoria.manning@monash.edu
Contact person for scientific queries
Name 107528 0
Victoria Manning
Address 107528 0
Turning Point
110 Church Street
Richmond, VIC 3121
Country 107528 0
Australia
Phone 107528 0
+61 428 337 961
Fax 107528 0
Email 107528 0
victoria.manning@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
There is no specific plan for making the dataset generally available. However, researchers interested in accessing de-identified data may contact the coordinating principal investigator to discuss which data they would like to analyse and obtaining additional ethical approval to share and analyse it.
When will data be available (start and end dates)?
Immediately following publication of primary outcome. De-identified datasets will be stored for at least 7 years following publication of the last paper arising from this study, or 7 years after the final report to the ethics committee, or 7 years after final reporting of outcomes on the clinical trials registry, whichever occurs latest.
Available to whom?
Researchers interested in accessing deidentified data who contact the coordinating principal investigator to discuss their analysis plan and who are willing to seek additional ethical approval to access the data.
Available for what types of analyses?
Meta-analysis, other methodologically sound purposes at discretion of the coordinating principal investigator.
How or where can data be obtained?
Researchers interested in accessing deidentified data must contact the coordinating principal investigator, Victoria Manning, at victoria.manning@monash.edu


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16360Study protocol  victoria.manning@monash.edu
16555Informed consent form  victoria.manning@monash.edu
16556Ethical approval  victoria.manning@monash.edu



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