Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001322628
Ethics application status
Approved
Date submitted
14/11/2023
Date registered
15/12/2023
Date last updated
15/04/2024
Date data sharing statement initially provided
15/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Modif-i Alcohol Community Trial: A clinical trial of the effectiveness of a “brain-training” smartphone app to help reduce alcohol use in people with alcohol use disorder
Scientific title
The Modif-i Alcohol Community trial: A randomised controlled trial to assess the effectiveness of an approach bias modification smartphone application to reduce alcohol use and craving among people with alcohol use disorder who are not seeking formal treatment
Secondary ID [1] 310514 0
National Health and Medical Research Council (NHMRC) grant application number: 2014954
Secondary ID [2] 310515 0
Services Australia identifier: RMS2713
Universal Trial Number (UTN)
U1111-1297-3402
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use disorder 331318 0
Condition category
Condition code
Mental Health 328074 328074 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered using the app Modif-i, which has been designed specifically for the trial. Modif-i delivers a cognitive bias modification (CBM) training task in which participants respond to alcohol and non-alcohol images that appear on their smartphone screen. Each image presentation is surrounded by a white "frame" that is either in portrait or landscape orientation. Participants are instructed to swipe images "away" (by swiping their finger upwards, causing the image to shrink and disappear) if images are displayed surrounded by a portrait frame, or towards themselves (causing the image to expand) if surrounded by a landscape-oriented frame. Each training session lasts approximately 3-5 minutes.

Modif-i will remind participants (using app notifications) to complete training sessions regularly for 4 weeks. After the 4-week intervention period, participants will have free access to the training task, but will not receive further notifications from the app reminding them to use it. App back-end data will show the time and date of each training session to allow researchers to quantify participants' adherence to the intervention.
Intervention code [1] 327049 0
Behaviour
Comparator / control treatment
There will be two control conditions:
One will be a sham-training condition, where participants complete training tasks each week which, like the intervention task described above, involves swiping images towards or away from oneself, based on the orientation of the "frame" around the image. However, in this control version, the training is not designed to reduce impulses to drink alcohol.

The second control condition will involve no training. For both control conditions, the intervention period will be 4 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 336139 0
Number of past-week heavy drinking days (defined as days on which participants consumed at least 50 grams ethanol), as measured by participants self-report.
Timepoint [1] 336139 0
Primary endpoint: 4 weeks after commencing app use
Other timepoints: 1, 2, and 3 weeks after commencing app use; 3-months after commencing app use, and 1 year after commencing app use
Secondary outcome [1] 427021 0
Change, relative to baseline, in frequency of alcohol craving, as measured by the Craving Experience Questionnaire frequency scale total score
Timepoint [1] 427021 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [2] 427022 0
Change, relative to baseline, in Severity of Dependence Scale scores for alcohol
Timepoint [2] 427022 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [3] 427023 0
Change, relative to baseline, in Alcohol Use Disorder Identification Test total score
Timepoint [3] 427023 0
1 year after commencing app use
Secondary outcome [4] 427024 0
Proportion of participants with an Alcohol Use Disorder Identification Test score of at least 8
Timepoint [4] 427024 0
1 year after commencing app use
Secondary outcome [5] 427025 0
Proportion of participants with an Alcohol Use Disorder Identification Test score of at least 16
Timepoint [5] 427025 0
1 year after commencing app use
Secondary outcome [6] 427026 0
Total number of standard drinks (defined as 10 grams of ethanol) consumed in the past week, as assessed by participant self-report
Timepoint [6] 427026 0
first, second, third, and 4th weeks of using the app; 3 months after commencing app use, 1 year after commencing app use
Secondary outcome [7] 427027 0
Total number of drinking days (defined as days on which any alcohol was consumed) in the past 28 days, as assessed by participants' self-report
Timepoint [7] 427027 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [8] 427029 0
Proportion of participants completely abstinent from alcohol for the entire past week - i.e., proportion of participants who self-report no alcohol consumption on any of the past 7 days.
Timepoint [8] 427029 0
1 week, 2 weeks, 3 weeks, 4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [9] 427031 0
Proportion of participants completely abstinent from alcohol for the entirety of past 4 weeks - i.e., proportion of participants who self-report no alcohol consumption on any day in the past 28 days.
Timepoint [9] 427031 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [10] 427033 0
Change (relative to baseline) in expectancy of positive effects from alcohol use, as assessed by a 2-item scale that asks participants to rate how relaxing and how fun they would expect alcohol use to be
Timepoint [10] 427033 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [11] 427034 0
Change, relative to baseline, in psychometric scores for the "Happiness" dimension of the Assessment of Quality of Life - 8D scale
Timepoint [11] 427034 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [12] 427035 0
Change, relative to baseline, in psychometric scores for the "Mental health" dimension of the Assessment of Quality of Life - 8D scale
Timepoint [12] 427035 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [13] 427036 0
Change, relative to baseline, in psychometric scores for the "Coping" dimension of the Assessment of Quality of Life - 8D scale
Timepoint [13] 427036 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [14] 427037 0
Change, relative to baseline, in psychometric scores for the "Relationships" dimension of the Assessment of Quality of Life - 8D scale
Timepoint [14] 427037 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [15] 427038 0
Change, relative to baseline, in psychometric scores for the "Self-worth" dimension of the Assessment of Quality of Life - 8D scale
Timepoint [15] 427038 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [16] 427039 0
Change, relative to baseline, in psychometric scores for the "Psychosocial" domain of the Assessment of Quality of Life - 8D scale
Timepoint [16] 427039 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [17] 427040 0
Change, relative to baseline, in Snaith-Hamilton Pleasure Scale score
Timepoint [17] 427040 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [18] 427041 0
Change in approach bias towards alcohol-related images, as measured by an alcohol approach avoidance task
Timepoint [18] 427041 0
4 weeks after commencing app use
Secondary outcome [19] 427042 0
Change in attention bias towards alcohol-related words, as measured by an alcohol Stroop task
Timepoint [19] 427042 0
4 weeks after commencing app use
Secondary outcome [20] 427044 0
Composite of individual, government, and social cost, estimated from a combination of Medicare Benefits Schedule and Pharmaceutical Benefits Scheme data linkage and questionnaires assessing participants' health service use and productivity. This will be used as an assessment of the cost-effectiveness of the app.
Timepoint [20] 427044 0
1 year after commencing app use
Also modelled over a 30-year period, using the Sheffield Alcohol Policy Model
Secondary outcome [21] 427046 0
Quality-adjusted life years, calculated based on Assessment of Quality of Life - 8D scale total utility scores. This will be used as an assessment of the cost-effectiveness of the app.
Timepoint [21] 427046 0
1 year after commencing app use
Secondary outcome [22] 427047 0
Change, relative to baseline, in Craving Experience Questionnaire frequency "Intensity" subscale score
Timepoint [22] 427047 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [23] 427048 0
Change, relative to baseline, in Craving Experience Questionnaire frequency "Imagery" subscale score
Timepoint [23] 427048 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [24] 427049 0
Change, relative to baseline, in Craving Experience Questionnaire frequency "Intrusiveness" subscale score
Timepoint [24] 427049 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [25] 427050 0
Change, relative to baseline, in Alcohol Use Disorder Identification Test "Consumption" subscale score
Timepoint [25] 427050 0
1 year after commencing app use
Secondary outcome [26] 429751 0
Change, relative to baseline, in the Approach and Avoidance of Alcohol Questionnaire "approach" scale scores
Timepoint [26] 429751 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [27] 429752 0
Change, relative to baseline, in the Approach and Avoidance of Alcohol Questionnaire "avoidance" scale scores
Timepoint [27] 429752 0
4 weeks, 3 months, and 1 year after commencing app use
Secondary outcome [28] 434055 0
Change, relative to baseline, in alcohol automaticity scores, as measured by the Self-Reported Behavioural Automaticity Index.
Timepoint [28] 434055 0
Secondary outcome [29] 434056 0
Change, relative to baseline, in alcohol automaticity scores, as measured by the Self-Reported Behavioural Automaticity Index.
Timepoint [29] 434056 0
4 weeks, 3 months, and 1 year after commencing app use

Eligibility
Key inclusion criteria
participants must, at the time of screening:
• Be aged 18+
• Own an Android or iOS smartphone with an Australian mobile number
• Have an Alcohol Use Disorders Identification Test (AUDIT) score of at least 16
• Report a desire to either cease or reduce their alcohol use
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
participants must, at the time of screening:
• Not be accessing formal treatment for alcohol problems currently, or within the past 28 days
• Not be planning to commence formal treatment for alcohol problems in the next 28 days.

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 concealed by use of randomisation sequences programmed into a central database. These sequences will not be accessible to staff responsible for pursuing follow-up data collection,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised generation of randomisation sequences using permuted blocks of variable size
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical significance will be ascertained using alpha=.05. The primary analysis of mean past-week HDDs at the end of the intervention period will occur after all 4-week assessments are complete. A follow-up analysis will be conducted when 1-year follow-ups are complete.

The repeated measurements of the outcome variables will be analysed by fitting linear mixed models using restricted maximum likelihood (REML) – this will allow selection of the most suitable variance-covariance model for the repeated measures, using Akaike’s Information Criterion, and exploration of commonality of time trends. The primary comparison between arms, of changes from pre to post intervention will be based on a t-test of the corresponding interaction contrast. Two supplementary analyses of the primary outcomes are planned: a complete-case analysis and a propensity score analysis to account for possibly different patterns of missingness in each arm. Exploratory analyses, including mixed models with covariates for gender and other baseline factors, including their interactions with treatment group, will be conducted to identify moderating factors. Exploratory analyses will also be conducted to test whether differences between groups emerge prior to the primary endpoint (e.g., after 1, 2, or 3 weeks). Candidate covariates, along with further details of all primary and secondary analyses, will be specified in a Statistical Analysis Plan reviewed and approved by a project steering committee and uploaded to the ANZCTR prior to database lock. Analyses will be conducted using the most appropriate procedures in Genstat, R and STATA.

Mean scores/values for continuous outcome variables (e.g., CEQ-F; SDS; AUDIT; alcohol expectancy; AQoL-8D psychometric total, domain, and dimension scores; SHAPS; past-week standard drinks; past-month drinking days; and approach bias) will be analysed in a similar manner to the primary analysis described above. For the CEQ-F, secondary analyses will also be conducted for each of its 3 subscales, and for the AUDIT, secondary analysis of the 3-item AUDIT-C subscale scores will also be conducted. Proportions of groups reporting complete past-week and past-month abstinence will be compared between groups at post-intervention, and 3-month follow-up, and 12-month follow-up using Pearson’s chi-squared. Proportions of groups with AUDIT scores of less than 8 or less than 16 at the 12-month follow-up will also be compared using Pearson’s chi-squared.

The health economic analyses are divided into two main aspects: 1) a within-trial period cost-effectiveness analysis and 2) a modelled life-time economic evaluation including both the within-trial and post-trial periods, which are separately described. Trial-based and modelled economic evaluations will be conducted from the patient, government and societal perspectives. Statistical analysis will be performed using Stata. All analyses will involve sensitivity analysis exploring the robustness of conclusions and structural and parameter uncertainty.

Within-trial analyses will estimate the additional cost per reduction of 1 HDD per week and per QALY over the 12 months following randomisation. Direct costs of the intervention include app development, delivery, and maintenance costs. Health care costs will be captured through data linkage (MBS & PBS) and the service use and productivity questionnaire. Where MBS and participant reported service use may overlap (e.g., some mental health services), MBS data will be used to validate the service use, but will be considered for exclusion from the analysis to avoid double counting. In this instance, patient reported service use is likely to be more comprehensive, as MBS does not represent all available services. A sensitivity analysis may explore the inclusion of all reported service use (MBS and self-reported). Estimation of HDDs will match the primary outcome analysis. The analysis will employ generalised linear models (GLM) for costs and QALYs to adjust for baseline characteristics identified in the primary analysis. Missing data will likely be accounted for through imputation.

Longer-term outcomes and costs will be estimated in a decision analytic model based on an existing alcohol policy appraisal model, the Sheffield Alcohol Policy Model. The Sheffield model estimates a range of acute and chronic health conditions and social harms (crime and workplace harms) resulting from both the mean (total weekly units of alcohol) and the peak (units of alcohol consumed on the heaviest drinking day in the previous 7 days) alcohol consumption of individuals (with risks adjusted for age and sex). Impacts on costs in the Sheffield model are quantified in monetary terms and health in QALYs, based on EQ-5D estimates for various conditions. The perspective of the model is broadly societal, including costs of health and social care, social harms and health related quality of life. The Sheffield model will be used to extend the 12-month follow up another 29 years, to a full 30 year time horizon. Estimates will be based on the alcohol consumption observed at the 12-month follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
15/02/2024
Date of last participant enrolment
Anticipated
28/03/2025
Actual
Date of last data collection
Anticipated
19/06/2026
Actual
Sample size
Target
1600
Accrual to date
158
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314717 0
Government body
Name [1] 314717 0
National Health and Medical Research Council
Country [1] 314717 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash Research Office, 26 Sports Walk, Level 1, Administration C, Clayton, VIC, 3800
Country
Australia
Secondary sponsor category [1] 317209 0
None
Name [1] 317209 0
Address [1] 317209 0
Country [1] 317209 0
Other collaborator category [1] 282820 0
University
Name [1] 282820 0
Deakin University
Address [1] 282820 0
221 Burwood Highway, Burwood, Victoria, 3125
Country [1] 282820 0
Australia
Other collaborator category [2] 282821 0
University
Name [2] 282821 0
University of Amsterdam
Address [2] 282821 0
P.O. Box 19268, 1000 GG Amsterdam, The Netherlands
Country [2] 282821 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313727 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 313727 0
26 Sports Walk, Level 1, Administration C, Clayton, VIC, 3800
Ethics committee country [1] 313727 0
Australia
Date submitted for ethics approval [1] 313727 0
13/10/2023
Approval date [1] 313727 0
13/11/2023
Ethics approval number [1] 313727 0
39827
Ethics committee name [2] 314144 0
Services Australia External Request Evaluation Committee
Ethics committee address [2] 314144 0
PO Box 7788, Canberra BC, ACT, 2610
Ethics committee country [2] 314144 0
Australia
Date submitted for ethics approval [2] 314144 0
14/11/2023
Approval date [2] 314144 0
Ethics approval number [2] 314144 0
RMS2713

Summary
Brief summary
We will test a smartphone app that delivers a type of cognitive training designed to reduce impulses to drink alcohol to see if it is an effective intervention for people drinking at harmful levels, but who are not otherwise engaged in treatment for alcohol problems. We will test outcomes including alcohol use, cravings, severity of dependence, quality of life, and cognitive biases. We also aim to determine the cost-effectiveness of the app. We predict that the version of the app that includes the cognitive training will lead to better outcomes than the control versions of the app.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129158 0
Prof Victoria Manning
Address 129158 0
Turning Point, 110 Church Street, Richmond, Victoria, 3121
Country 129158 0
Australia
Phone 129158 0
+61 428 337 961
Fax 129158 0
Email 129158 0
victoria.manning@monash.edu
Contact person for public queries
Name 129159 0
Prof Victoria Manning
Address 129159 0
Turning Point, 110 Church Street, Richmond, Victoria, 3121
Country 129159 0
Australia
Phone 129159 0
+61 428 337 961
Fax 129159 0
Email 129159 0
victoria.manning@monash.edu
Contact person for scientific queries
Name 129160 0
Dr Joshua Garfield
Address 129160 0
Turning Point, 110 Church Street, Richmond, Victoria, 3121
Country 129160 0
Australia
Phone 129160 0
+61 3 8413 8711
Fax 129160 0
Email 129160 0
joshuag@turningpoint.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All deidentified participant data except for data provided by Services Australia
When will data be available (start and end dates)?
Immediately after final publication is accepted, until 15 years following publication of the last paper arising from this study, or 15 years after the final report to the ethics committee, or 15 years after final reporting of outcomes on the clinical trials registry, whichever occurs latest
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve the aims of the proposal, as approved in a data sharing agreement between the researcher seeking access to the data and Monash University.
How or where can data be obtained?
Researchers interested in accessing data may contact the principal investigator, Prof Victoria Manning by emailing victoria.manning@monash.edu. Sharing data will require completion of a data sharing agreement between the researchers (and/or their institution) and Monash University, & may require further ethical review. Researchers seeking access to data will need to bear any associated costs.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20747Study protocol    To preserve blinding, the protocol will be attache... [More Details]
20748Statistical analysis plan    A Statistical Analysis Plan will be drafted by the... [More Details]
20749Informed consent form    Since there are different versions of the consent ... [More Details]
20750Ethical approval    386525-(Uploaded-14-11-2023-12-09-09)-Study-related document.pdf



Results publications and other study-related documents

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