Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000985785
Ethics application status
Approved
Date submitted
4/06/2022
Date registered
13/07/2022
Date last updated
13/07/2022
Date data sharing statement initially provided
13/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining methods to support self-guided attentional bias modification for alcohol consumption in young adults
Scientific title
Investigating the effectiveness of Functional Imagery Training as a motivation enhancement to self-guided attentional bias modification training for young adults seeking to reduce alcohol consumption
Secondary ID [1] 307205 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excess alcohol consumption 326551 0
Condition category
Condition code
Mental Health 323809 323809 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited through news posts and advertisements on social media (e.g., Facebook; see attachments). The capacity to decide whether or not to participate will be assumed based upon their responding to the advertisements for participants and by accessing the initial online survey, which will be preceded by a Participation Information Sheet Recruitment material will refer potential participants to a Qualtrics webpage displaying screening questions. Screened participants will then view a detailed Participation Information Sheet that participants will be asked to read and indicate their consent to participate by clicking on a response button before proceeding to the baseline survey items. All participants will receive email reminders to complete online activities and follow up surveys.

Baseline survey questions (presented to screened respondents) will include demographic items, Alcohol Use Disorders Identification Test, Vividness of Visual Imagery Questionnaire (VVIQ; Marks, 1973) and the 7-day version of Timeline Follow Back for alcohol consumption (TLFB; Sobell & Sobell, 1992). Respondents will be asked to reveal their work/study status (ie. working full time, looking for work, full time study, part time study), age (years and months) and gender (ie. male, female, other).

The research will use an attentional retraining technique, known as Attentional Bias Modification Training (ABMT), in the context of alcohol consumption. All conditions will be administered a modified dot-probe task (MacLeod et al., 2002), a computer-delivered task commonly used in anxiety, pain and addiction research to implicitly train participants to re-direct attention away from threats to competing neutral cues. In the alcohol version, participants are trained to focus their attention away from alcohol images toward neutral images (e.g. soft drinks). The proposed online training procedure will follow a protocol of eight online sessions over four weeks as used by McGeary et al. (2014) in a home-delivered ABM RCT for young adult heavy drinkers. Each session will follow the same training procedure. Each session takes approximately 10 minutes to complete.

Participants in the intervention condition will receive self-guided functional imagery training (FIT) exercises, delivered online in conjunction with the ABM training procedure. Functional imagery training (FIT) is an evidence-based motivational intervention that combines goal-directed mental imagery training with motivational interviewing (MI) techniques designed to support planning and commitment to personal goal achievement. The FIT exercise will be based on Fitz (Kavanagh & Mani, 2018), a self-guided mobile app that follows the manualised protocols established in counsellor-led FIT interventions (Rhodes et al., 2018; Solbrig et al., 2019) to support positive behaviour change. The first session will guide users through a mental imagery exercise. Later sessions will encourage users to use mental imagery to build motivation for their goal of completing training (e.g., “Have you noticed that when you think about something that happened in the past, sometimes it is like you are back there again and seeing things you saw and heard, and doing things all over again?”). Later sessions will encourage users to use mental imagery to build motivation for their goal (e.g., “imagine what would get better…if you made the change”). Each session will involve a reflection followed by a guided audio imagery exercise. Each exercise will take approximately 5 minutes to complete. One FIT exercise will accompany each training session, therefore 8 FIT exercises will be delivered during the overall period of engagement.

All participants will be sent a post-trial survey 35 days after commencing their first ABM session. For participants who complete the full regime this will be one week after completing their final session. Participants who explicitly withdraw or do not commence the first ABM session will not be contacted for follow-up. The follow-up survey will contain the seven-day TLFB (similar to the version presented in the baseline survey), a Sentence Completion Task (similar to the baseline survey), and a program engagement survey designed to assess satisfaction with the training program. Program Engagement Survey. Overall satisfaction will be investigated using a five-item instrument adapted from a post trial survey developed by March et al. (2018). Participants in the intervention condition will also be asked several qualitative questions about their experiences of FIT. Additionally, to measure engagement with FIT content, participants in the FIT condition will be asked to rate the vividness of each exercise on a visual analogue scale (0 to 10).

All training sessions are self guided, and accessed via the program link. Intervention and measures are delivered online. The online training procedure will follow a protocol of eight online sessions over four weeks. Participants will complete all tasks on their personal computer in a location of their choosing.Participants’ adherence to the ABM training (dependent variable) will be measured by a count of the number of training trials attempted within four weeks (28 days) following the commencement of each participant’s training program.
Intervention code [1] 323724 0
Behaviour
Intervention code [2] 323725 0
Treatment: Other
Comparator / control treatment
Participants in the active control condition will receive a brief breath counting technique developed by Shuai et al. (2020). The task will immediately precede each ABM training session. The task will take approximately 4 minutes to complete. The task will be delivered using an audio recording which will guide participants through instructions to relax and breathe to promote attention in the present. An example of the opening audio: “To begin with… if it’s comfortable to do so, please sit with your back relatively straight, your legs uncrossed, your head and neck comfortably balanced on your shoulders and your hands resting in your lap or on the table in a comfortable way…”

Participants’ engagement with the comparator task will be tracked from usage data collected in the web application (start and end log times for each session). Adherence will also be measured by a count of the number of training trials attempted within four weeks (28 days) following the commencement of each participant’s training program.
Control group
Active

Outcomes
Primary outcome [1] 331598 0
Adherence to prescribed training trials will be measured by a count of the number of training trials completed in eight sessions over a 4 week training period. The number of training trials will be assessed by exporting database capture of each participant's usage record.
Timepoint [1] 331598 0
Measured after each training session (8 times).
Secondary outcome [1] 410449 0
Change in self-reported number of standard alcoholic drinks consumed will be measured using the Timeline Follow Back (TLFB; Sobell & Sobell, 1992), a calendar-based instrument that has been used widely in addiction studies to measure recent consumption patterns. The 7-day version of TLFB will be presented to participants to record recent drinking consumption in the screening survey (baseline) and post-trial assessment.
Timepoint [1] 410449 0
At baseline and 35 days after commencement of training.

Eligibility
Key inclusion criteria
(1) Adult drinkers who drink alcohol regularly (as measured by the first item on the Alcohol Use Disorders Identification Test (AUDIT; Babor et al., 2001), and
(2) indicate a desire to reduce alcohol consumption (an alcohol version of the Motivation to Stop Scale (De Vocht et al., 2018) will be used to screen for motivation to reduce alcohol consumption. The MTSS consists of one item featuring seven response categories representing strength of desire to reduce drinking (e.g. (1) “I don't want to cut down on drinking alcohol” to (7) “I REALLY want to cut down on drinking alcohol and intend to in the next month”). Only participants who select (3) “I want to cut down on drinking alcohol but haven't thought about when’ or a higher desire, will be eligible).
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) have no access to a desktop or laptop computer connected to reliable internet
2) are not able or willing to provide informed consent to participate

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocations are computer-generated in permuted blocks (by gender). The first participant in each gender group will be allocated to one of two conditions using a computerized random number generator (ie. odd number = active condition, or even number = control) and subsequent participants will be alternated to active or control group thereafter.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
To our knowledge there has been no previously reported research for between groups comparison of Attention Bias Modification (ABM) trial adherence to guide a priori effect size selection. Across the small number of studies that have investigated treatment adherence, results are difficult to quantify due to underreporting and heterogenous measurement of adherence (Marker & Norton, 2018). Therefore, a medium effect size of 0.5 has instead been selected to inform the power analysis, which would be equivalent to a 25% increase in mean training trials completed for functional imagery training (FIT) condition compared to ABM only. Based on this effect size, a target sample size of 102 would be sufficient with a power of 80% and alpha error rate of 0.05 for a one-tail analysis, according to G*Power Statistical Analysis (Faul et al., 2007). While this estimate is based on limited information and assumptions about the standard deviations of two groups, in the absence of prevalence data it suggests that the target of a medium effect size would deliver a substantial improvement in training participation.

Data analysis:
For the primary outcome measure, a t-test will be conducted to determine if there is a significant group difference in the number of training trials completed at the conclusion of the program. For the secondary outcome measure, a repeated measures ANOVA will be used to test whether FIT-enhanced ABM is associated with a significantly larger treatment effect compared to ABM-alone, as measured by reported number of standard drinks consumed in the seven days prior to two time points: baseline and post training follow up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/07/2022
Actual
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
10/12/2022
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311506 0
University
Name [1] 311506 0
Queensland University of Technology (QUT)
Country [1] 311506 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology (QUT)
Address
Kelvin Grove campus
170 Victoria Park Road
Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 313017 0
None
Name [1] 313017 0
Address [1] 313017 0
Country [1] 313017 0
Other collaborator category [1] 282324 0
Individual
Name [1] 282324 0
Dr. Melanie White
Address [1] 282324 0
Queensland University of Technology (QUT)
School of Psychology and Counselling
170 Victoria Park Road
Kelvin Grove, QLD 4059
Country [1] 282324 0
Australia
Other collaborator category [2] 282325 0
Individual
Name [2] 282325 0
Dr Jennifer Connolly
Address [2] 282325 0
Centre for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country [2] 282325 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310968 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 310968 0
Office of Research Ethics and Integrity
GPO Box 2434
QLD 4000
Ethics committee country [1] 310968 0
Australia
Date submitted for ethics approval [1] 310968 0
05/04/2022
Approval date [1] 310968 0
10/05/2022
Ethics approval number [1] 310968 0
5512

Summary
Brief summary
This study will investigate the effectiveness of Functional Imagery Training (FIT) as a motivation enhancement to self-guided attentional bias modification training (ABM) for young people seeking to reduce alcohol consumption. ABM training for alcohol is an emerging intervention designed to train individuals to disengage attention to alcohol cues in order to disrupt the cognitive elaboration process that precedes alcohol consumption as posited by Elaborated Intrusion theory (EI; Kavanagh et al., 2009).

This project will extend our understanding of motivational enhancements to improve adherence to self-guided, digital health interventions. While there is promising early evidence for effects of FIT on treatment participation, this intervention has not yet been applied to improving adherence to ABM training regimens. Therefore, the results of this study will contribute to our knowledge about the potential for FIT to improve training completion rates and lead to better outcomes for ABM users and creators of self-guided applications.

The aim of this study will be to determine if a self-guided, online FIT add-on, developed based on results and feedback from the earlier studies, increases adherence to multi-session ABM. The following hypotheses will be tested.
Hypothesis 1: Participation in FIT will increase adherence to internet-based attentional bias modification training (intervention) for young people compared to ABM training and breath counting training (control), as measured by a significant group difference in the number of training trials completed.
Hypothesis 2: Participation in FIT will be associated with improved therapeutic outcomes compared to control group, measured by a difference in self-reported number of alcoholic drinks consumed in the seven days prior to the conclusion of the trial compared to the seven days prior to commencing the trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119530 0
Mr Christopher Cahill
Address 119530 0
Queensland University of Technology (QUT)
School of Psychology and Counselling
170 Victoria Park Road
Kelvin Grove, QLD 4059
Country 119530 0
Australia
Phone 119530 0
+61 408560039
Fax 119530 0
Email 119530 0
c.cahill@qut.edu.au
Contact person for public queries
Name 119531 0
Mr Christopher Cahill
Address 119531 0
Queensland University of Technology (QUT)
School of Psychology and Counselling
170 Victoria Park Road
Kelvin Grove, QLD 4059
Country 119531 0
Australia
Phone 119531 0
+61 408560039
Fax 119531 0
Email 119531 0
c.cahill@qut.edu.au
Contact person for scientific queries
Name 119532 0
Mr Christopher Cahill
Address 119532 0
Queensland University of Technology (QUT)
School of Psychology and Counselling
170 Victoria Park Road
Kelvin Grove, QLD 4059
Country 119532 0
Australia
Phone 119532 0
+61 408560039
Fax 119532 0
Email 119532 0
c.cahill@qut.edu.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 of the individual participant data collected during the trial, after de-identification and relevant publication.
When will data be available (start and end dates)?
Data will be available immediately following publication and will be available for 5 years following publication.
Available to whom?
Data will be available after dissemination upon request and at the discretion of the researchers.
Available for what types of analyses?
Data will be available for primary and secondary analyses on the basis that the secondary analysis is related to the topic of interest.
How or where can data be obtained?
Data will be available from the principal researcher (c.cahill@qut.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16302Ethical approval  c.cahill@qut.edu.au
16303Study protocol  c.cahill@qut.edu.au
16304Informed consent form  c.cahill@qut.edu.au
16305Other  c.cahill@qut.edu.au Access to ABM online files, provided under creativ... [More Details]



Results publications and other study-related documents

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