Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000633583
Ethics application status
Approved
Date submitted
29/02/2024
Date registered
16/05/2024
Date last updated
16/05/2024
Date data sharing statement initially provided
16/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Modif-i Tobacco Trial: A clinical trial of the efficacy of a “brain-training” smartphone app to assist tobacco cessation
Scientific title
A randomised controlled trial testing the efficacy of a novel approach bias modification smartphone application (Modif-i Tobacco) to reduce tobacco use and craving among people with tobacco use disorder
Secondary ID [1] 310852 0
Victorian Medical Research Acceleration Fund (VMRAF) Reference number: GA-F4559779-1692
Universal Trial Number (UTN)
U1111-1299-5410
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Use Disorder 331886 0
Condition category
Condition code
Mental Health 328616 328616 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. When participants download Modif-i, the app will prompt them to answer questions about past-week and past-month tobacco use and then complete a short (~3-minute) test of their approach/avoidance bias to smoking-related and non-smoking related images. Following these tasks, instructions for the training task will be displayed and participants will be prompted to complete their first training task.

Modif-i delivers a cognitive bias modification (CBM) training task in which participants respond to tobacco and non-tobacco 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. At the end of each week, it will also prompt them to answer questions about past-week tobacco use. After the end of the 4th week, it will also prompt them to complete the test of approach/avoidance bias for a second time. 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.

Participants' adherence to the intervention will be assessed using app data regarding the number of training sessions completed and the times they were completed at. To maintain blinding, additional details of the task are not currently made available to the public. However a full protocol including all details will be uploaded when data collection is complete.
Intervention code [1] 327267 0
Behaviour
Comparator / control treatment
There will be a sham-training control condition. To maintain blinding, specific details of the task are withheld until data collection is complete.
Control group
Placebo

Outcomes
Primary outcome [1] 336427 0
Past-week abstinence from tobacco
Timepoint [1] 336427 0
1 week, 2 weeks, 3 weeks, 4 weeks, and 12 weeks following randomisation. 4-weeks post-randomisation is the primary endpoint.
Primary outcome [2] 336428 0
Feasibility: proportion of participants using the app weekly for at least the first 4 weeks
Timepoint [2] 336428 0
At the conclusion of study
Primary outcome [3] 336429 0
Feasibility: Number of training sessions completed during the 4-week intervention period
Timepoint [3] 336429 0
4 weeks after randomisation
Secondary outcome [1] 428338 0
Acceptability: functionality ratings
Timepoint [1] 428338 0
4 weeks after randomisation
Secondary outcome [2] 428339 0
Acceptability: aesthetics
Timepoint [2] 428339 0
4 weeks after randomisation
Secondary outcome [3] 428340 0
Acceptability: app quality
Timepoint [3] 428340 0
4 weeks after randomisation
Secondary outcome [4] 428665 0
Number of cigarettes smoked in the past week.
Timepoint [4] 428665 0
baseline; 1, 2, 3, 4, and 12 weeks after randomisation.
Secondary outcome [5] 428666 0
Number of days tobacco use in the past week
Timepoint [5] 428666 0
baseline; 1, 2, 3, 4, and 12 weeks after randomisation
Secondary outcome [6] 428667 0
Number of days on which tobacco was used in the past 4 weeks
Timepoint [6] 428667 0
baseline, 12 weeks after randomisation
Secondary outcome [7] 428668 0
Complete abstinence from tobacco during the past 4 weeks
Timepoint [7] 428668 0
12 weeks after randomisation
Secondary outcome [8] 428669 0
Intensity of cigarette craving
Timepoint [8] 428669 0
baseline; 4 and 12 weeks after randomisation
Secondary outcome [9] 428670 0
Frequency of intense cigarette craving
Timepoint [9] 428670 0
baseline; 4 and 12 weeks after randomisation
Secondary outcome [10] 428673 0
Severity of nicotine dependence
Timepoint [10] 428673 0
baseline; 4 and 12 weeks after randomisation
Secondary outcome [11] 428674 0
Tobacco approach bias
Timepoint [11] 428674 0
baseline, 4-week follow-up
Secondary outcome [12] 428675 0
Feasibility: recruitment rate
Timepoint [12] 428675 0
8 months after commencing recruitment
Secondary outcome [13] 430859 0
craving intensity as measured by a single-item visual analogue scale
Timepoint [13] 430859 0
immediately before first session of training; immediately after first session of training
Secondary outcome [14] 430860 0
physical wellbeing
Timepoint [14] 430860 0
baseline; 4 and 12 weeks after randomisation
Secondary outcome [15] 430861 0
Psychological wellbeing
Timepoint [15] 430861 0
baseline; 4 and 12 weeks after randomisation
Secondary outcome [16] 430862 0
Quality of life
Timepoint [16] 430862 0
baseline; 4 and 12 weeks after randomisation

Eligibility
Key inclusion criteria
- Residing in Victoria, Australia
- Own an Android or iOS smartphone with an Australian mobile number
- Smoking daily in the past month, with an average of at least 5 cigarettes per day
- Report willingness to attempt to quit smoking within the next week
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Using an e-cigarette or vapouriser at least weekly in the past month.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted blocks of variable size
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
Statistical significance will be ascertained using p=.05. Any participants who commence at least 1 session of their allocated training will be included in the ITT analysis population for the primary end-point.

Primary outcomes:
Feasibility and acceptability data will be analysed using descriptive statistics. For feasibility, this will include the proportion of participants completing at least one session in each week of the intervention period, as well as mean and standard deviation (and/or median and quartile cut-offs, if distribution of these data suggests these statistics are more appropriate) of the number of training sessions completed during the 4-week intervention period. For acceptability, we will assess and means and standard deviations (and/or median and quartile cut-offs, if distribution of these data suggests these statistics are more appropriate) of scores on uMARS subscales.

Differences between groups in proportions of participants reporting past-week abstinence during the 4 weeks of the intervention and at the 3-month follow-up will be analysed using multilevel mixed effects (MME) logistic regression. Main effects of time and intervention group, as well as their interaction, will be tested. Time will be analysed as a continuous variable, coded as 1 for first week of the intervention, 2 for second week of the intervention, 3 for the third week, 4 for the final week, and 12 for the 3 month follow up. If there is a significant interaction between time and group, Pearson’s chi square will be used to test whether rates of abstinence differ between groups at each of the 5 individual time points tested. Since the 4th week of the intervention is designated as the primary endpoint for this outcome, a pre-planned Pearson’s chi-square test will be conducted testing differences between groups in abstinence rate at this time-point regardless of the outcome of the MME logistic regression model.

The primary analysis of past-week abstinence will include all participants from the ITT analysis set who provide outcome data. An additional sensitivity analysis will include all participants lost to follow-up and assume (i.e., impute) that they are not abstinent. Additional per-protocol analysis will include only those participants in the ApBM group who completed at least 4 ApBM sessions.

Secondary outcomes:
For continuous secondary outcomes assessed at multiple time points, MME linear regression will test main effects of time and group, and their interaction. Time will be coded as described above, with the baseline time-point coded as 0 where baseline values are included in the analysis. If significant interactions are found, two-tailed post-hoc t-tests will be used to test whether groups differ at individual time-points.

For number of cigarettes smoked in the last week, the model will include baseline; weeks 1, 2, 3, and 4; and 3-month follow-up. For analyses of past-week smoking days, we assume that participants will be daily smokers at baseline, and hence there will be little or no variance at baseline (i.e., all or most participants will have 7 past-week smoking days). Hence analysis of these outcomes will not include baseline past-week smoking days, but will control for baseline past-week number of cigarettes.

Models testing QSU-Brief scores, FTND scores, and ratings on the 3 ATOP wellbeing/quality of life items will use data from baseline, week 4, and 3-month follow-up. If participants were past-week abstinent at a follow-up, and therefore not administered the FTND at that time point, they will be assigned an FTND score of 0 at that time-point for the purpose of analysis. Approach bias will be analysed using data from baseline and week 4. The ability of a single session of training to alter immediate craving will be analysed using pre- and post-session craving VAS data from the first session of training, with time coded as pre-session = 0 and post-session = 1.

Frequency of past-week craving will be analysed as an ordered 4-category categorical variable using MME ordered logistic regression to test the effect of time (baseline, week 4, and 3-month follow-up), group, and their interaction. Past-month smoking days at the 3-month follow-up will be compared between groups using a 2-tailed t-test, while past-month abstinence at this time-point will be compared between groups using Pearson’s chi-square. Recruitment feasibility will be assessed with descriptive statistics assessing how long it takes to recruit 200 participants who are recruited and commence at least 1 session of their allocated training.

Psychometric properties of AAT:
Since the AAT task will be specially constructed for smartphone-based measurement in this trial, and we are not aware of any prior data on the reliability and validity of app-based tobacco approach bias measurement, we will conduct psychometric analyses of this measurement task. The internal consistency of the AAT will be estimated using Monte Carlo split-half reliability. Test-retest reliability will be analysed using baseline and 4-week data from control groups only (since we expect these indices to be modified only in the ApBM group). We will explore whether baseline AAT scores correlate with baseline tobacco craving (QSU-Brief scores; past-week frequency of craving; pre-session 1 VAS craving scores), dependence severity (FTND), and number of cigarettes per week, using Pearson or Spearman correlations depending on the distribution of the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
3/03/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315107 0
Government body
Name [1] 315107 0
THE STATE OF VICTORIA DEPARTMENT OF HEALTH
Country [1] 315107 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
Level 4, 5 Arnold Street., Box Hill, VIC, 3128
Country
Australia
Secondary sponsor category [1] 317208 0
None
Name [1] 317208 0
Address [1] 317208 0
Country [1] 317208 0
Other collaborator category [1] 282867 0
University
Name [1] 282867 0
Monash University
Address [1] 282867 0
Monash Research Office, 26 Sports Walk, Level 1, Administration C, Clayton, VIC, 3800
Country [1] 282867 0
Australia
Other collaborator category [2] 282868 0
Charities/Societies/Foundations
Name [2] 282868 0
Cancer Council Victoria
Address [2] 282868 0
Level 8, 200 Victoria Parade, East Melbourne, Victoria, 3002
Country [2] 282868 0
Australia
Other collaborator category [3] 282869 0
University
Name [3] 282869 0
Deakin University
Address [3] 282869 0
221 Burwood Highway, Burwood, Victoria, 3125
Country [3] 282869 0
Australia
Other collaborator category [4] 282870 0
University
Name [4] 282870 0
Flinders University
Address [4] 282870 0
GPO Box 2100, Adelaide, 5001, South Australia
Country [4] 282870 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314045 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 314045 0
Ethics committee country [1] 314045 0
Australia
Date submitted for ethics approval [1] 314045 0
25/01/2024
Approval date [1] 314045 0
29/02/2024
Ethics approval number [1] 314045 0
E24-002-101584
Ethics committee name [2] 314113 0
CANCER COUNCIL VICTORIA HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [2] 314113 0
Ethics committee country [2] 314113 0
Australia
Date submitted for ethics approval [2] 314113 0
29/02/2024
Approval date [2] 314113 0
Ethics approval number [2] 314113 0
Ethics committee name [3] 314114 0
Monash University Human Research Ethics Committee
Ethics committee address [3] 314114 0
Ethics committee country [3] 314114 0
Australia
Date submitted for ethics approval [3] 314114 0
04/03/2024
Approval date [3] 314114 0
Ethics approval number [3] 314114 0

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

Contacts
Principal investigator
Name 130226 0
Prof Victoria Manning
Address 130226 0
Turning Point, 110 Church Street, Richmond, Victoria, 3121
Country 130226 0
Australia
Phone 130226 0
+61 428 337 961
Fax 130226 0
Email 130226 0
[email protected]
Contact person for public queries
Name 130227 0
Victoria Manning
Address 130227 0
Turning Point, 110 Church Street, Richmond, Victoria, 3121
Country 130227 0
Australia
Phone 130227 0
+61 428 337 961
Fax 130227 0
Email 130227 0
[email protected]
Contact person for scientific queries
Name 130228 0
Joshua Garfield
Address 130228 0
Turning Point, 110 Church Street, Richmond, Victoria, 3121
Country 130228 0
Australia
Phone 130228 0
+61 3 8413 8711
Fax 130228 0
Email 130228 0
[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
When will data be available (start and end dates)?
Immediately after final publication is accepted, until 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 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 Prof Victoria Manning. Sharing data will require completion of a data sharing agreement between the researchers (and/or their institution) and Eastern Health and/or Monash University, & may require further review by Eastern Health Human Research Ethics Committee. Researchers seeking access to data will need to bear any associated costs.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20855Study protocol    To preserve blinding, the protocol will be attache... [More Details]
20856Informed consent form    386792-(Uploaded-29-02-2024-15-49-23)-Study-related document.docx
20857Ethical approval    386792-(Uploaded-29-02-2024-15-49-36)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.