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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]

National Health and Medical Research Council (NHMRC) grant application number: 2014954

Secondary ID [2]

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

Condition category

Condition code

Mental Health

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]

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]

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]

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]

Change, relative to baseline, in frequency of alcohol craving, as measured by the Craving Experience Questionnaire frequency scale total score

Timepoint [1]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [2]

Change, relative to baseline, in Severity of Dependence Scale scores for alcohol

Timepoint [2]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [3]

Change, relative to baseline, in Alcohol Use Disorder Identification Test total score

Timepoint [3]

1 year after commencing app use

Secondary outcome [4]

Proportion of participants with an Alcohol Use Disorder Identification Test score of at least 8

Timepoint [4]

1 year after commencing app use

Secondary outcome [5]

Proportion of participants with an Alcohol Use Disorder Identification Test score of at least 16

Timepoint [5]

1 year after commencing app use

Secondary outcome [6]

Total number of standard drinks (defined as 10 grams of ethanol) consumed in the past week, as assessed by participant self-report

Timepoint [6]

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]

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]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [8]

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]

1 week, 2 weeks, 3 weeks, 4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [9]

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]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [10]

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]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [11]

Change, relative to baseline, in psychometric scores for the "Happiness" dimension of the Assessment of Quality of Life - 8D scale

Timepoint [11]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [12]

Change, relative to baseline, in psychometric scores for the "Mental health" dimension of the Assessment of Quality of Life - 8D scale

Timepoint [12]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [13]

Change, relative to baseline, in psychometric scores for the "Coping" dimension of the Assessment of Quality of Life - 8D scale

Timepoint [13]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [14]

Change, relative to baseline, in psychometric scores for the "Relationships" dimension of the Assessment of Quality of Life - 8D scale

Timepoint [14]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [15]

Change, relative to baseline, in psychometric scores for the "Self-worth" dimension of the Assessment of Quality of Life - 8D scale

Timepoint [15]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [16]

Change, relative to baseline, in psychometric scores for the "Psychosocial" domain of the Assessment of Quality of Life - 8D scale

Timepoint [16]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [17]

Change, relative to baseline, in Snaith-Hamilton Pleasure Scale score

Timepoint [17]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [18]

Change in approach bias towards alcohol-related images, as measured by an alcohol approach avoidance task

Timepoint [18]

4 weeks after commencing app use

Secondary outcome [19]

Change in attention bias towards alcohol-related words, as measured by an alcohol Stroop task

Timepoint [19]

4 weeks after commencing app use

Secondary outcome [20]

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]

1 year after commencing app use
Also modelled over a 30-year period, using the Sheffield Alcohol Policy Model

Secondary outcome [21]

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]

1 year after commencing app use

Secondary outcome [22]

Change, relative to baseline, in Craving Experience Questionnaire frequency "Intensity" subscale score

Timepoint [22]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [23]

Change, relative to baseline, in Craving Experience Questionnaire frequency "Imagery" subscale score

Timepoint [23]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [24]

Change, relative to baseline, in Craving Experience Questionnaire frequency "Intrusiveness" subscale score

Timepoint [24]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [25]

Change, relative to baseline, in Alcohol Use Disorder Identification Test "Consumption" subscale score

Timepoint [25]

1 year after commencing app use

Secondary outcome [26]

Change, relative to baseline, in the Approach and Avoidance of Alcohol Questionnaire "approach" scale scores

Timepoint [26]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [27]

Change, relative to baseline, in the Approach and Avoidance of Alcohol Questionnaire "avoidance" scale scores

Timepoint [27]

4 weeks, 3 months, and 1 year after commencing app use

Secondary outcome [28]

Change, relative to baseline, in alcohol automaticity scores, as measured by the Self-Reported Behavioural Automaticity Index.

Timepoint [28]

Secondary outcome [29]

Change, relative to baseline, in alcohol automaticity scores, as measured by the Self-Reported Behavioural Automaticity Index.

Timepoint [29]

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?

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]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

414 La Trobe St, Melbourne VIC 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Deakin University

Address [1]

221 Burwood Highway, Burwood, Victoria, 3125

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

University of Amsterdam

Address [2]

P.O. Box 19268, 1000 GG Amsterdam, The Netherlands

Country [2]

Netherlands

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

26 Sports Walk, Level 1, Administration C, Clayton, VIC, 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/10/2023

Approval date [1]

13/11/2023

Ethics approval number [1]

39827

Ethics committee name [2]

Services Australia External Request Evaluation Committee

Ethics committee address [2]

PO Box 7788, Canberra BC, ACT, 2610

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

14/11/2023

Approval date [2]

Ethics approval number [2]

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

Prof Victoria Manning

Address

Turning Point, 110 Church Street, Richmond, Victoria, 3121

Country

Australia

Phone

+61 428 337 961

Fax

[email protected]

Contact person for public queries

Name

Victoria Manning

Address

Turning Point, 110 Church Street, Richmond, Victoria, 3121

Country

Australia

Phone

+61 428 337 961

Fax

[email protected]

Contact person for scientific queries

Name

Joshua Garfield

Address

Turning Point, 110 Church Street, Richmond, Victoria, 3121

Country

Australia

Phone

+61 3 8413 8711

Fax

[email protected]

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 [email protected]. 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.	Type	Other Details	Attachment
20747	Study protocol	To preserve blinding, the protocol will be attache... [More Details]
20748	Statistical analysis plan	A Statistical Analysis Plan will be drafted by the... [More Details]
20749	Informed consent form	Since there are different versions of the consent ... [More Details]
20750	Ethical approval		386525-(Uploaded-14-11-2023-12-09-09)-Study-related document.pdf

Results publications and other study-related documents

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No additional documents have been identified.

Trial Review

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