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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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1252-8422

Trial acronym

Linked study record

Health condition

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

Anxiety symptoms

Alcohol use

Alcohol-related harms/consequences

Condition category

Condition code

Mental Health

Addiction

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]

6-weeks post-baseline

Primary outcome [2]

Feasibility of the program, measured by the mean number of sessions completed

Timepoint [2]

6-weeks post-baseline

Primary outcome [3]

Feasibility of the program, measured by % drop-out from the sessions and surveys

Timepoint [3]

6-weeks post-baseline (primary timepoint) and 3-months post-baseline

Secondary outcome [1]

Primary outcome. Acceptability of the program, measured by the Client Satisfaction Questionnaire

Timepoint [1]

6-weeks post-baseline

Secondary outcome [2]

Primary outcome. Acceptability/usability of the program, measured by the System Usability Scale

Timepoint [2]

6-weeks post-baseline

Secondary outcome [3]

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]

6-weeks post-baseline

Secondary outcome [4]

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]

Following completion of each training session

Secondary outcome [5]

Primary outcome. Recruitment feasibility, as measured by % potential participants successfully recruited who agree to participate (i.e. uptake)

Timepoint [5]

At the time of (attempted) recruitment

Secondary outcome [6]

Primary outcome. Recruitment feasibility, as measured by % eligible patients who agree to participate and then commence training

Timepoint [6]

At the time of commencement of training

Secondary outcome [7]

Primary outcome. Recruitment feasibility, as measured by % declined participation and excluded for each criterion

Timepoint [7]

At the time of (attempted) recruitment and commencement of training.

Secondary outcome [8]

Alcohol approach biases assessed by the Alcohol Approach Task (AAT)

Timepoint [8]