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Trial registered on ANZCTR


Registration number
ACTRN12620001273976
Ethics application status
Approved
Date submitted
25/09/2020
Date registered
25/11/2020
Date last updated
6/10/2022
Date data sharing statement initially provided
25/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial examining the feasibility, acceptability and preliminary efficacy of an internet-delivered cognitive bias modification to reduce co-occurring social anxiety and alcohol use in young Australians
Scientific title
A pilot randomised controlled trial examining the feasibility, acceptability and preliminary efficacy of an internet-delivered cognitive bias modification to reduce co-occurring social anxiety and alcohol use in young Australians
Secondary ID [1] 302403 0
Nil
Universal Trial Number (UTN)
U1111-1252-8422
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety symptoms

 319191 0
Alcohol use 319192 0
Alcohol-related harms/consequences 319193 0
Condition category
Condition code
Mental Health 317158 317158 0 0
Addiction
Mental Health 317159 317159 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate the feasibility, acceptability and preliminary efficacy of an internet-delivered Approach Bias Modification (ApBM) plus Interpretation Bias Modification (IBM) brain training program for social anxiety and hazardous alcohol use in young Australians.

The ApBM+IBM intervention contains a component that addresses anxiety-related interpretation biases and another that addresses alcohol approach biases, delivered via JavaScript, in addition to their current treatment (i.e., treatment as usual). Prior to the commencement of first training session, participants will receive one online motivational interviewing module, which will discuss the interrelationship between anxiety and alcohol use, inform participants about the existence of automatically activated processes (referred to as mental habits) and the importance of changing them, provide a treatment rationale, and help clients set goals for what they hope to achieve by participating in the training. Training will take approximately 20 minutes per session.

INTERVENTION COMPONENTS:

Alcohol ApBM component:
ApBM is used to reduce maladaptive alcohol approach behaviours and increase alcohol avoidance behaviours in response to alcohol-related stimuli (Wiers et al., 2009). Participants are instructed to pull or push a computer mouse towards or away from their body in response to an irrelevant feature of the images (i.e., the orientation as portrait or landscape) shown on a computer screen, while ignoring the content of the pictures. Two categories of pictures are used: alcoholic and colour and shape matched non-alcoholic beverages. Contingent upon a pull or push movement, the picture zooms in (becomes larger on the screen to generate the subjective experience of moving towards the images’ content i.e., an approach behaviour) or zooms out (becomes smaller on the screen to give a sense of avoidance behaviour). An incorrect response is followed with error feedback, as indicated by a red ‘X’ on the screen. The frame orientation used to implicitly train avoidance behaviours will contain alcoholic images in 95% of presentations, while the remaining 5% of frames will contain images of non-alcoholic beverages. Likewise, the frame orientation used to implicitly train approach behaviours will contain non-alcoholic images in 95% of presentations, while the remaining 5% of frames will contain images of alcoholic beverages. Format movement assignments are counterbalanced (half of the participants pull pictures that came in landscape format and push portrait pictures and half of the participants received the opposite instruction).To familiarise participants with the task requirements, participants are asked to complete a brief practice round involving empty rectangular frames in landscape or portrait format. Following the practice trials, participants are exposed to presentations of frames containing images of alcoholic and non-alcoholic beverages, in a random order. The alcoholic and non-alcoholic images were selected to represent the beverage type and brands most commonly consumed by this population, as documented in a recent acceptability study (Prior et al., 2020).

Anxiety IBM program component:
IBM seeks to train people to make benign (i.e., neutral or positive) interpretations of ambiguous social scenarios and reduce the negative threat interpretations that are commonly associated with social anxiety. Participants are trained to resolve ambiguous social scenarios with either positive or neutral outcomes, through completion of a word fragment (Mathews & Mackintosh, 2000). Each scenario consists of three lines that are ambiguous in terms of valence or emotional interpretation. Participants are instructed to imagine/visualise themselves in each situation described. One word of the story is presented as a word fragment and disambiguates the story in a positive or neutral way. Participants are asked to complete the fragment as quickly as possible by pressing the spacebar when they know what the word is, and then to press the key corresponding to the missing letter. Reaction times are recorded. After this, a comprehension question appears that reinforces the assigned meaning when the word fragment was completed (response options = ‘yes’ or ‘no’). They subsequently receive feedback (correct vs. wrong answer, with a corresponding smiley or sad face emoji) to reinforce the interpretation imposed by the word fragment. The social scenarios are translated versions of those used in previous research (Mathews & Mackintosh, 2000, Salemink et al., 2014, Salemink et al., 2009), adapted for the current study’s target age range of 18-25 years and the Australian context (Prior et al., 2020).

DELIVERY FORMATS:

The IBM+ApBM program will be delivered in two different formats:
1) With weekly sessions alternating between IBM and ApBM, described below

On alternating weeks, participants will receive either the IBM or ApBM component of the program (i.e. each session will switch between focussing on re-training anxiety or alcohol biases), plus treatment as usual. Participants will be asked to complete 10 sessions (5 IBM & 5 ApBM) over a 5-week period. Access to each session will be opened at a rate of two per week, and participants will be given one-week flexibility to complete the training sessions.

IBM component: Participants will be presented with 6 blocks of 10 social scenarios (i.e., 60 scenarios per session; 300 across the 5 IBM sessions). Each block will contain 8 positive target scenarios and 2 foil/irrelevant scenarios that have one positive and one negative outcome, to make the induction less obvious.

ApBM component: For each training session, participants will complete a brief practice round, followed by presentations of frames containing 20 images of alcoholic and 20 images of non-alcoholic beverages, in a random order. Each alcoholic and non-alcoholic beverage is presented three times, for a total of 120 image presentations.

2) With weekly sessions combining both IBM and ApBM, described below

Each week, participants will receive both the IMB and ApBM components of the program (i.e. each session will be shortened in length, with 50:50 focus on re-training both alcohol and anxiety biases), plus treatment as usual. Participants will be asked to complete 10 sessions (combined IMB & ApBM) over a 5-week period. Training will take approximately 20 minutes per session, with 10 minutes focused on IMP and 10 minutes on ApBM. Access to each session will be opened at a rate of two per week, and participants will be given one-week flexibility to complete the training sessions.

IBM component: The IBM for this group will mirror group 1, with the exception of the length of training. Participants will be re-trained using 30 scenarios in each of the 10 sessions (i.e., 30 scenarios per session; 300 across the 10 IBM components).

ApBM component: The ApBM for this group will mirror group 1, with the exception of the length of training. Participants will see a total of 60 (rather than 120) alcoholic and non-alcoholic beverage image presentations per session. That is, presentations of frames containing 10 images of alcoholic and 10 images of non-alcoholic beverages, in a random order. Each alcoholic and non-alcoholic beverage is presented three times (i.e., 60 scenarios per session; 600 scenarios across the 10 ApBM sessions)

ADHERENCE:

Data from each session will be recorded, including start and finish times, as well as proportion completed. Session commencement and completion data will be used to evaluate adherence to the intervention (i.e. proportion of sessions completed).
Intervention code [1] 318687 0
Treatment: Other
Intervention code [2] 318899 0
Behaviour
Comparator / control treatment
The control group will receive treatment as usual, which will be the model of care provided in accordance with standard practice at participating services. This group will be put on a waitlist and will be offered the opportunity to receive the IBM+ApBM training program (in whichever format is deemed preferable by participants) after all follow-up surveys and measurements are taken at the 3-month assessment point).
Control group
Active

Outcomes
Primary outcome [1] 325239 0
Feasibility of the program, measured by the % who complete the 10-session protocol (as a proportion of those who commence at least 1 session of training).
Timepoint [1] 325239 0
6-weeks post-baseline
Primary outcome [2] 325240 0
Feasibility of the program, measured by the mean number of sessions completed
Timepoint [2] 325240 0
6-weeks post-baseline
Primary outcome [3] 325241 0
Feasibility of the program, measured by % drop-out from the sessions and surveys
Timepoint [3] 325241 0
6-weeks post-baseline (primary timepoint) and 3-months post-baseline
Secondary outcome [1] 387303 0
Primary outcome. Acceptability of the program, measured by the Client Satisfaction Questionnaire
Timepoint [1] 387303 0
6-weeks post-baseline
Secondary outcome [2] 387304 0
Primary outcome. Acceptability/usability of the program, measured by the System Usability Scale
Timepoint [2] 387304 0
6-weeks post-baseline
Secondary outcome [3] 387305 0
Primary outcome. Acceptability of the program, measured by 13 self-generated acceptability items (e.g. using a 5-point likert scale from 0 ‘not at all’ to 4 ‘very’ participants will rate aspects of the programme such as how acceptable the delivery was, how user friendly, how motivating the tasks were, how logical the programme was, whether the tasks were engaging etc)
Timepoint [3] 387305 0
6-weeks post-baseline
Secondary outcome [4] 387306 0
Primary outcome. Acceptability/usability of the program, measured by four post-session user experience items, including: motivation while training, how much participants enjoyed training, how much they liked the delivery format, and whether they found the training simple and user friendly, using a 5-point Likert scale (Not at all’, ‘A little’, ‘Somewhat’, ‘Very’, ‘Extremely’)
Timepoint [4] 387306 0
Following completion of each training session
Secondary outcome [5] 387307 0
Primary outcome. Recruitment feasibility, as measured by % potential participants successfully recruited who agree to participate (i.e. uptake)
Timepoint [5] 387307 0
At the time of (attempted) recruitment
Secondary outcome [6] 387308 0
Primary outcome. Recruitment feasibility, as measured by % eligible patients who agree to participate and then commence training
Timepoint [6] 387308 0
At the time of commencement of training
Secondary outcome [7] 387310 0
Primary outcome. Recruitment feasibility, as measured by % declined participation and excluded for each criterion
Timepoint [7] 387310 0
At the time of (attempted) recruitment and commencement of training.
Secondary outcome [8] 387311 0
Alcohol approach biases assessed by the Alcohol Approach Task (AAT)
Timepoint [8] 387311 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [9] 387312 0
Anxiety interpretation biases assessed by the Interpretation Recognition Task (IREC-T)
Timepoint [9] 387312 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [10] 387313 0
Social anxiety symptoms, assessed by the Social Phobia Scale and Social Interaction Anxiety Scale (Short form)
Timepoint [10] 387313 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [11] 387315 0
Social anxiety symptoms, assessed by the Liebowitz Social Anxiety Scale
Timepoint [11] 387315 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [12] 387316 0
Generalised anxiety measured by the Generalised Anxiety Disorder-7 Scale
Timepoint [12] 387316 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [13] 388159 0
Alcohol consumption (total standard drinks in the past month and drinks per day) and frequency of binge-drinking (past month consumption of 5 or more standard drinks on one occasion), assessed by Timeline Follow-back.
Timepoint [13] 388159 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [14] 388160 0
Alcohol-related harms (past month), assessed by the Brief Young Adult Alcohol Consequences questionnaire.
Timepoint [14] 388160 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [15] 388161 0
Alcohol use motives, assessed by the Drinking Motives Questionnaire-Revised.
Timepoint [15] 388161 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [16] 388162 0
Positive alcohol expectancies, assessed by the Alcohol Tension-Reduction Expectancies scale.
Timepoint [16] 388162 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [17] 388163 0
Severity of alcohol dependence, assessed by the Severity of Alcohol Dependence Questionnaire.
Timepoint [17] 388163 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [18] 388164 0
Alcohol cravings, assessed by the Severity of Alcohol Craving Questionnaire-Short Form-Revised.
Timepoint [18] 388164 0
Baseline, 6-weeks post-baseline and 3-months post-baseline.
Secondary outcome [19] 389237 0
Sleep quality/quantity, as assessed by the Pittsburgh Sleep Quality Index
Timepoint [19] 389237 0
Baseline, 6-weeks post-baseline and 3-months post-baseline
Secondary outcome [20] 402474 0
Weekly alcohol use (Timeline Follow Back), among all participants including the control participants.
Timepoint [20] 402474 0
Weekly during the intervention period for a maximum of 6 weeks
Secondary outcome [21] 402475 0
Weekly social anxiety symptoms (Social Phobia Weekly Summary Scale), among all participants including the control participants.
Timepoint [21] 402475 0
Weekly during the intervention period for a maximum of 6 weeks

Eligibility
Key inclusion criteria
Key inclusion criteria are:
i) Australian aged 18-30 years
ii) Harmful or hazardous levels of alcohol consumption (AUDIT greater than or equal to 8)
iii) Mild symptoms of social interaction or performance anxiety (SIAS-6 greater than or equal to 7 OR SPS-6 greater than or equal to 2)
iv) Have access to internet via a laptop/PC and the Internet (either in the private residence of the participant, at a treatment service, or willingness to use the public library/other suitable venue)
v) Currently receiving treatment for anxiety or alcohol use problems
vi) Willing to complete sessions, if allocated to one of the active intervention groups
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria are:
i) Inability to provide contact information (i.e. phone and address)
ii) Insufficient English literacy
iii) Active symptoms of psychosis (Psychosis Screening Questionnaire greater than or equal to 3)
iv) History of neurological disease or head injury with a loss of consciousness exceeding 30 minutes
v) Self-reported intellectual disability/cognitive impairment
vi) Eyesight not normal or not corrected to normal

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)
Participants will be recruited via 1) clinical referral, 2) poster and flyer advertisements in services, 3) online advertisements and social media. Allocation into groups will be concealed by using a computer-generated randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be individually randomised to one of the three study groups i.e., i) ApBM+IBM combined plus TAU, ii) ApBM+IBM alternating plus TAU, or iii) TAU waitlist control.

To avoid bias, participants will be randomised to either the intervention or control conditions via the trial website using a computer-generated randomisation sequence. Participants will not be blind to their group allocation (i.e., they will know which group they were randomly allocated to).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this is a pilot trial, a formal power calculation was not required. A sample size of 90 young people will provide sufficient data on the feasibility, acceptability and preliminary efficacy of the program. This approach to determining a sample size is consistent with existing protocols for pilot trials and is essential to inform the sample size of a future definitive randomised controlled trial aiming to assess the efficacy of the ApBM+IBM program. Data will be collated and analysed using Stata Statistics/Data Analysis software (StataCorp).

Descriptive statistics for primary (i.e., feasibility and acceptability) and secondary outcomes (i.e., efficacy) will be conducted based on frequencies and cross-tabulations.

For secondary outcomes related to cognitive biases: An approach bias score is computed using a conventional D-score algorithm as the difference between the median reaction times (RTs) for correct alcohol trials (push alcohol minus pull alcohol)/SD, minus the corresponding difference for correct non-alcohol trials (push non-alcohol minus pull non-alcohol)/SD. Positive scores indicate a relative tendency to approach alcohol stimuli, negative ones indicate an avoidance tendency. For interpretation bias measurements, similarity ratings of the four kinds of statements allows for analyses of the endorsement of positive versus negative interpretations of novel ambiguous scenarios following training (Targets), compared to measures of tendency to simply endorse non-specific positive and negative statements (Foils). Average similarity ratings for each of the categories (negative target, negative foil, positive target, positive foil) across the ten statements will be calculated. An interpretation bias score for target statements will be calculated by subtracting the average similarity rating for negative target statements from the average similarity rating for positive target statements, with a negative score indicating a negative bias and a positive score indicating a positive/benign bias. An interpretation bias score for foil statements will be calculated in a similar manner.

Analyses for secondary efficacy outcomes will use multi-level mixed effects analysis for repeated measures (MMRM) which is a flexible analytic approach for modelling change over time that has emerged as a flexible and rigorous method for analysing RCT data. The approach has a number of advantages over traditional approaches, including better treatment of missing data and flexible modelling of variance at the individual level, time effects and the within-subject covariance structure. All models will use baseline measurements as the reference point to estimate participant-specific starting points and change over time. Intervention condition will be represented by a dummy-coded variable, and the condition by time interaction was examined to assess between-group differences in treatment response over time. Treatment dose (session completion) will be entered as an independent variable in secondary analyses in order to examine moderation of treatment effects. Analyses will be consistent with an intention-to-treat framework, with all randomised participants included in analysis models. Missing data will be accommodated in these models using maximum likelihood (ML) estimation. All models will include a random intercept and preliminary models will be estimated and model fit statistics examined to determine the most appropriate model and covariance structure. For outcomes with evidence of significant intervention effects, Cohen’s d will be calculated from model estimated marginal means and standard errors to determine the size of effect between conditions at the relevant endpoint.

Additional covariates/mediators/moderators to be included in these analyses may include: i) Psychological and pharmacological treatment (e.g. type of treatment and frequency), ii) Readiness/motivation to change, as assessed via a readiness ruler (e.g., on a scale of 1 to 10, how ready are you to change your anxiety/drinking, and 3) the University of Rhode Island Change Assessment. These will all be measured at baseline, 6-weeks post-baseline and 3-months post-baseline.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/01/2021
Actual
1/03/2021
Date of last participant enrolment
Anticipated
Actual
31/07/2022
Date of last data collection
Anticipated
15/11/2022
Actual
Sample size
Target
90
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306823 0
Charities/Societies/Foundations
Name [1] 306823 0
Australian Rotary Health
Country [1] 306823 0
Australia
Funding source category [2] 306824 0
Government body
Name [2] 306824 0
NHMRC Centre of Research Excellence in Prevention and Early Intervention in Mental Illness and Substance Use
Country [2] 306824 0
Australia
Funding source category [3] 306825 0
University
Name [3] 306825 0
University of Sydney Lifespan Research Network
Country [3] 306825 0
Australia
Funding source category [4] 312376 0
University
Name [4] 312376 0
Brain and Mind Centre, University of Sydney
Country [4] 312376 0
Australia
Funding source category [5] 312377 0
University
Name [5] 312377 0
University of Sydney: 1) Rewarding Research Success grant, 2) Global Development Award, 3) DVCR Support for COVID-19 impacted research
Country [5] 312377 0
Australia
Primary sponsor type
University
Name
Matilda Centre, The University of Sydney
Address
The Matilda Centre
Level 6, Jane Foss Russell building (G02)
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 307625 0
None
Name [1] 307625 0
Address [1] 307625 0
Country [1] 307625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306986 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 306986 0
Ethics committee country [1] 306986 0
Australia
Date submitted for ethics approval [1] 306986 0
21/02/2020
Approval date [1] 306986 0
03/06/2020
Ethics approval number [1] 306986 0
#2020/135

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

Contacts
Principal investigator
Name 39582 0
Dr Katrina Prior
Address 39582 0
The Matilda Centre
Level 6, Jane Foss Russell building (G02)
University of Sydney NSW 2006
Country 39582 0
Australia
Phone 39582 0
+61 2 8627 9032
Fax 39582 0
Email 39582 0
katrina.prior@sydney.edu.au
Contact person for public queries
Name 39583 0
Katrina Prior
Address 39583 0
The Matilda Centre
Level 6, Jane Foss Russell building (G02)
University of Sydney NSW 2006
Country 39583 0
Australia
Phone 39583 0
+61 2 8627 9032
Fax 39583 0
Email 39583 0
katrina.prior@sydney.edu.au
Contact person for scientific queries
Name 39584 0
Katrina Prior
Address 39584 0
The Matilda Centre
Level 6, Jane Foss Russell building (G02)
University of Sydney NSW 2006
Country 39584 0
Australia
Phone 39584 0
+61 2 8627 9032
Fax 39584 0
Email 39584 0
katrina.prior@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be de-identified and aggregated at the group level. IPD will not be available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9285Study protocol  katrina.prior@sydney.edu.au
9286Statistical analysis plan  katrina.prior@sydney.edu.au
9287Informed consent form  katrina.prior@sydney.edu.au
9288Ethical approval  katrina.prior@sydney.edu.au



Results publications and other study-related documents

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