Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000252314
Ethics application status
Approved
Date submitted
16/02/2017
Date registered
17/02/2017
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a Computer-based Inhibitory Smoking Training (INST) program to assist individuals to quit or reduce smoking.
Scientific title
A Randomised Controlled Trial examining the Efficacy of Training Response Inhibition to Smoking in Nicotine Dependent Individuals.
Secondary ID [1] 291068 0
nil
Universal Trial Number (UTN)
Trial acronym
Inhibitory Smoking Training (INST)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Smoking 301865 0
Addiction 301866 0
Nicotine dependence 301867 0
Condition category
Condition code
Mental Health 301545 301545 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an online GoNoGo response inhibition training task as developed by Lawrence et al. (2015). The task used in this study has been modified to incorporate images of smoking. The intervention will consist of smoking-related pictures, non-smoking behaviour-related pictures, and neutral pictures. The neutral pictures are incorporated to prevent participants from easily identifying the associative rules of the task such that learning will occur through automatic processes as opposed to explicit control. Smoking-related pictures will always be paired with no-go signals, non-smoking pictures will always be paired with go signals, and neutral pictures will be paired equally with go and no-go signals. The training will consist of 6 blocks of 36 trials in each block. There are 14 sessions altogether which occur once a day for two weeks. Participants must quickly indicate whether the picture is located to the left or the right of the computer screen on their keyboard ('go' trials). On half of the trials, the frame around the picture will be bolded ('no go' cue) and the participants must not respond. Participants will be provided with feedback on their accuracy and mean go reaction time at the end of each block. Each training session will last for approximately 10 minutes. T
Reference: Lawrence, N. S., O’Sullivan, J., Parslow, D., Javaid, M., Adams, R. C., Chambers, C. D., … Verbruggen, F. (2015). Training response inhibition to food is associated with weight loss and reduced energy intake. Appetite, 95, 17–28. doi:10.1016/j.appet.2015.06.009
Intervention code [1] 297056 0
Behaviour
Intervention code [2] 297057 0
Lifestyle
Comparator / control treatment
The active control is a general inhibition training task and is in the same format as the intervention, except only contains neutral pictures. The active control training is identical to that described in Lawrence et al. (2015).
Control group
Active

Outcomes
Primary outcome [1] 301058 0
Smoking cessation Yes/No
Measured by the Timeline Follow Back method (Sobell & Sobell, 1976)
Timepoint [1] 301058 0
Post-intervention, 1-month follow-up, 3-month follow-up
Primary outcome [2] 301059 0
Number of cigarettes smoked
Measured by the Timeline Follow Back method (Sobell & Sobell, 1976)
Timepoint [2] 301059 0
Post-intervention, 1-month follow-up, 3-month follow-up
Secondary outcome [1] 331617 0
Nicotine Craving
Smoking Craving Questionnaire (Johnson 2001)
Timepoint [1] 331617 0
Post-intervention, 1-month follow-up, 3-month follow-up
Secondary outcome [2] 331618 0
Self-efficacy
Visual analogue Scale "How confident do you feel right now that you can achieve your goal reducing/quitting smoking"
Timepoint [2] 331618 0
Post-intervention, 1-month follow-up, 3-month follow-up
Secondary outcome [3] 331622 0
Severity of nicotine dependence
Fagerstrom measure of Nicotine Dependence
Heatherton, Kozlowski, Frecker, Fagerstrom (1991)
Timepoint [3] 331622 0
Post-intervention, 1-month follow-up, 3-month follow-up
Secondary outcome [4] 331623 0
Impulsivity - behavioural and self-report

Barratt measure of impulsivity (BIS II) (self-report)
Stop Signal Task (behavioural)
Timepoint [4] 331623 0
Post-intervention, 1-month follow-up, 3-month follow-up
Secondary outcome [5] 331627 0
Positive valence towards smoking cues
Smoking specific Valence measure adapted from Lawrence et al 2015
Timepoint [5] 331627 0
Post-intervention, 3-month follow-up

Eligibility
Key inclusion criteria
Regular cigarette use- smokes 10 or more cigarettes per day on average for at least the past 12 months
DSM V Diagnosis of Tobacco Use Disorder
Reside in Melbourne Metropolitan Area (need to meet them face to face)
Completed at least year 9 at a mainstream school or equivalent
Regular access to a computer and internet on a daily basis for the next two week
Express an intention to reduce or quit smoking
Between the ages of 18 - 60
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
High risk use of alcohol or drugs (other than nicotine)
No period of abstinence from nicotine (excluding e.g. hospital stays) longer than 2 weeks in the past 3 months
Reports of a brain injury or a loss of consciousness for more than 30 minutes
Currently using anti-craving medication such as Champix (varenicline) or Zyban (buproprion)
Use of psychotropic medications such as antidepressants, anxiolytics or antipsychotics
Primary nicotine use is via e-cigarettes
Individuals who use nicotine replacement therapy (e.g. Nicorette patches) will be excluded if they cannot refrain from using them during the two-week training period.

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 a treatment group which the the researcher is unaware of and not involved in communicating
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 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
Multi-level modelling will be utilised to assess primary and secondary outcomes
Hierarchical regressions will be utilised to assess mediators and moderators

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
we reached the required sample size for adequate power earlier than anticipated due to less attrition and greater adherence to the protocol than anticipated
Date of first participant enrolment
Anticipated
21/02/2017
Actual
22/02/2017
Date of last participant enrolment
Anticipated
3/09/2018
Actual
29/07/2017
Date of last data collection
Anticipated
17/12/2018
Actual
22/12/2017
Sample size
Target
150
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295518 0
University
Name [1] 295518 0
Deakin University, School of Psychology
Country [1] 295518 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Petra Staiger
Address
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 294337 0
Individual
Name [1] 294337 0
Dr Melissa Hayden
Address [1] 294337 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country [1] 294337 0
Australia
Secondary sponsor category [2] 294492 0
Individual
Name [2] 294492 0
Karen Guo
Address [2] 294492 0
School of Psychology
Deakin University
221 Burwood highway
Burwood Campus
Burwood 3125
Victoria
Country [2] 294492 0
Australia
Secondary sponsor category [3] 294493 0
Individual
Name [3] 294493 0
Laura Hughes
Address [3] 294493 0
School of Psychology
Deakin University
221 Burwood highway
Burwood Campus
Burwood 3125
Victoria
Country [3] 294493 0
Australia
Secondary sponsor category [4] 294494 0
Individual
Name [4] 294494 0
Jason Bos
Address [4] 294494 0
School of Psychology
Deakin University
221 Burwood highway
Burwood Campus
Burwood 3125
Victoria
Country [4] 294494 0
Australia
Secondary sponsor category [5] 294495 0
Individual
Name [5] 294495 0
Dr Natalia Lawrence
Address [5] 294495 0
School of Psychology
University of Exeter
Exeter
EX4 4QG
Country [5] 294495 0
United Kingdom
Other collaborator category [1] 279437 0
Individual
Name [1] 279437 0
Professor Ben Richardson
Address [1] 279437 0
Cairnmillar Institute
993 Burke Rd
Camberwell, 3124
Victoria
Country [1] 279437 0
Australia
Other collaborator category [2] 279438 0
Individual
Name [2] 279438 0
Professor Ron Borland
Address [2] 279438 0
Cancer Council of Victoria
615 St Kilda Road
Melbourne, 3004
Victoria
Country [2] 279438 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296843 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 296843 0
Human Research Ethics Office
Deakin Research Integrity
Deakin University
221 Burwood Hwy
Burwood, VIC 3125
Ethics committee country [1] 296843 0
Australia
Date submitted for ethics approval [1] 296843 0
23/11/2015
Approval date [1] 296843 0
22/02/2016
Ethics approval number [1] 296843 0
2015-298

Summary
Brief summary
Despite the supports and treatments available to assist smoking cessation, relapse remains high amongst smokers who attempt to quit. An important factor that has been identified to contribute to relapse is difficulties with impulse control, also known as response inhibition. Smokers have been found to exhibit reduced response inhibition, that is, difficulties inhibiting an automatic response such as smoking, Difficulties with response inhibition has been hypothesised to be a predictor of relapse following a quit attempt. Therefore, it would be beneficial to target response inhibition during this time period to assist in achieving and maintaining abstinence. While response inhibition interventions have not yet been investigated in smokers, other studies have found it to be effective in changing unhealthy behaviours in heavy drinkers, dieters and overweight adults. This Randomised Controlled Trial aims to investigate whether response inhibition training is effective for reducing smoking in those who are dependent on nicotine, It will also examine how a number of mediators and moderators. Our research group is collaborating with Dr Natalia Lawrence to adapt her program which was developed and evaluated in the UK in relation to food inhibition training. Participants will be allocated to either a treatment group or an active control group. The response inhibition group will complete two weeks of the smoking response inhibition training program, while the control group will complete a general response inhibition training program. All participants will complete fourteen online training sessions over a two-week period and will provide follow-up data relating to their smoking status three time points after they have completed the training - post intervention, one and three month follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63874 0
A/Prof Petra Staiger
Address 63874 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 63874 0
Australia
Phone 63874 0
+61 3 9244 6876
Fax 63874 0
Email 63874 0
petra.staiger@deakin.edu.au
Contact person for public queries
Name 63875 0
A/Prof Petra Staiger
Address 63875 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 63875 0
Australia
Phone 63875 0
+61 3 9244 6876
Fax 63875 0
Email 63875 0
petra.staiger@deakin.edu.au
Contact person for scientific queries
Name 63876 0
A/Prof Petra Staiger
Address 63876 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 63876 0
Australia
Phone 63876 0
+61 3 9244 6876
Fax 63876 0
Email 63876 0
petra.staiger@deakin.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled trial of inhibitory control training for smoking cessation and reduction.2019https://dx.doi.org/10.1037/ccp0000424
N.B. These documents automatically identified may not have been verified by the study sponsor.