JMIR FORMATIVE RESEARCH

Prior et al

Original Paper

Web-Based Cognitive Bias Modification Program for Young People
With Social Anxiety and Hazardous Alcohol Use: Feasibility,
Acceptability, and Preliminary Efficacy Study
Katrina Prior1, BCom, BScPsych (Hons), PhD; Elske Salemink2, MSc, PhD; Monique Piggott1, BPsych (Hons);
Victoria Manning3, BScPsych (Hons), MSc, PhD; Reinout W Wiers4, MSc, PhD; Bethany A Teachman5, BA, PhD;
Maree Teesson1, BScPsych (Hons), PhD; Andrew J Baillie6, BScPsych (Hons), MPsych, PhD; Alison Mahoney7,8,
BPsych (Hons), DPsych, PhD; Lauren McLellan9, BPsych (Hons), DPsych; Nicola C Newton1, BPsych (Hons), PhD;
Lexine A Stapinski1, BPsych (Hons), MPsych, PhD
1Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, Australia

2

Experimental Psychopathology Lab, Department of Clinical Psychology, Utrecht University, Utrecht, Netherlands

3

Eastern Health Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia

4

Addiction Development and Psychopathology (ADAPT)-lab, Department of Psychology, University of Amsterdam, Amsterdam, Netherlands

5

Department of Psychology, School of Arts and Sciences, University of Virginia, Charlottesville, VA, United States

6

Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia

7

Clinical Research Unit for Anxiety and Depression, St Vincent's Public Hospital, Sydney, Australia

8

School of Psychiatry, University of New South Wales, Sydney, Australia

9

Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, Australia

Corresponding Author:
Katrina Prior, BCom, BScPsych (Hons), PhD
Matilda Centre for Research in Mental Health and Substance Use
The University of Sydney
Level 6, Jane Foss Russell building (G02)
Sydney, 2006
Australia
Phone: 61 286279032
Email: katrina.prior@sydney.edu.au

Abstract
Background: Interpretation bias modification (IBM) and approach bias modification (ApBM) cognitive retraining interventions
can be efficacious adjunctive treatments for improving social anxiety and alcohol use problems. However, previous trials havenot examined the combination of these interventions in a young, comorbid sample.
Objective: This study aims to describe the feasibility, acceptability, and preliminary efficacy of a web-based IBM+ApBM
program for young adults with social anxiety and hazardous alcohol use (“Re-Train Your Brain”) when delivered in conjunction
with treatment as usual (TAU).
Methods: The study involved a 3-arm randomized controlled pilot trial in which treatment-seeking young adults (aged 18-30y) with co-occurring social anxiety and hazardous alcohol use were randomized to receive (1) the “integrated” Re-Train Your
Brain program, where each session included both IBM and ApBM (50:50 ratio), plus TAU (35/100, 35%); (2) the “alternating”
Re-Train Your Brain program, where each session focused on IBM or ApBM in an alternating pattern, plus TAU (32/100, 32%);or (3) TAU only (33/100, 33%). Primary outcomes included feasibility and acceptability, and secondary efficacy outcomes
included changes in cognitive biases, social anxiety symptoms, and alcohol use. Assessments were conducted at baseline, after
the intervention period (6 weeks after baseline), and 12 weeks after baseline.
Results: Both Re-Train Your Brain program formats were feasible and acceptable for young adults. When coupled with TAU,
both integrated and alternating programs resulted in greater self-reported improvements than TAU only in anxiety interpretationbiases (at the 6-week follow-up; Cohen d=0.80 and Cohen d=0.89) and comorbid interpretation biases (at the 12-week follow-up;
Cohen d=1.53 and Cohen d=1.67). In addition, the alternating group reported larger improvements over the control group in

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generalized social anxiety symptoms (at the 12-week follow-up; Cohen d=0.83) and alcohol cravings (at the 6-week follow-up;
Cohen d=0.81). There were null effects on all other variables and no differences between the intervention groups in efficacy
outcomes.
Conclusions: Should these findings be replicated in a larger randomized controlled trial, Re-Train Your Brain has the potential
to be a scalable, low-cost, and non–labor-intensive adjunct intervention for targeting interpretation and comorbidity biases aswell as generalized anxiety and alcohol-related outcomes in the real world.
Trial
Registration:
AustralianNew
Zealand
Clinical
TrialsRegistry
ACTRN12620001273976;
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364131
International Registered Report Identifier (IRRID): RR2-10.2196/28667(JMIR Form Res 2023;7:e46008) doi: 10.2196/46008
KEYWORDS
alcohol; anxiety; cognitive bias modification; interpretation bias; approach bias; young adult; mobile phone

Introduction
Background
Social anxiety and alcohol use disorders are 2 substantial publichealth issues and are among the leading causes of the global
burden of disease [1,2]. When they co-occur, there is typicallya mutually reinforcing relationship between the disorders thatmaintains and exacerbates both conditions in a vicious
feed-forward cycle (ie, people drink to reduce anxiety in the
short term; however, the consequences of drinking, such as
shame, guilt, and alcohol withdrawal, lead to greater social
anxiety in the long term) [3-5]. This cycle continues andcompounds, leading to a greater severity of symptoms,
functional impairment, and poorer response to standard
treatments [3,6-9].
Both social anxiety and alcohol use disorders are characterized
and driven by underlying (modifiable) cognitive biases, butthese cognitive mechanisms have largely been examined andtreated separately. For instance, some people with social anxiety
tend to construe ambiguous stimuli, scenarios, and events in anegative or threatening manner [10-12]. Such “interpretationbiases” have been associated with the development,
maintenance, and severity of social anxiety symptoms anddisorders [13,14]. By contrast, people with alcohol problems
often exhibit an automatically triggered tendency to approach(rather than avoid) alcohol [15,16]. This “alcohol approach bias”
is implicated in the development of heavy drinking (especiallyin adolescence and young adulthood), predicts future alcohol
use among adults with an alcohol use disorder [16], and has
been associated with relapse following treatment [17,18].
There is increasing support for the efficacy of “cognitive bias
modification” (CBM) training in reducing anxiety interpretation
and alcohol approach biases via the repeated completion ofcomputer-based cognitive tasks [19-25], although there are also
many mixed findings [26,27]. Although methodologies varyacross studies, “interpretation bias modification” (IBM;predominantly used for anxiety symptoms and disorders)typically involves participants reading a set of ambiguous social
scenarios (ie, neither positively nor negatively valanced) andthen resolving the ambiguity of the scenarios in a positive or
neutral manner. Support for the efficacy of IBM has beengarnered by a recent review of meta-analyses [25] and 2https://formative.jmir.org/2023/1/e46008

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systematic reviews and network meta-analyses [23,24] of CBM
programs for anxiety. The reviews concluded that single-session
or multisession IBM training among clinical, subclinical, andnonclinical samples can significantly reduce threat-related
interpretation biases (and increase positive interpretations) andanxiety levels compared with sham or placebo training or a
waitlist control condition. Similar positive findings have beenreported in meta-analyses of IBM among children andadolescents specifically (aged <18 y) [28].
Several large randomized controlled trials (RCTs) [29-34] andreviews [19-21] have also provided evidence in support of theefficacy of treatment for alcohol approach biases, known as“approach bias modification” (ApBM), when delivered toclinical samples in conjunction with standard evidence-based
treatments, such as cognitive behavioral therapy. In ApBM,
individuals are taught to avoid alcohol-related cues by repeatedly
making an “avoidance” movement (eg, “pushing away” ajoystick or computer mouse) in response to alcohol-related
images displayed on a computer screen. Studies show thatpeople who receive 4 to 12 brief ApBM treatment sessions
alongside abstinence-oriented residential treatment as usual(TAU) report significantly reduced rates of relapse (by 8%-13%)
1 year later, relative to participants who received TAU only
[29-33]. ApBM appears to be particularly beneficial for patientswith a comorbid condition, with patients who have a
co-occurring anxiety or depressive disorder experiencing astronger reduction in relapse after ApBM training comparedwith those with an alcohol use disorder alone [33].
Although these findings are encouraging, empirical support for
the efficacy of ApBM programs as stand-alone interventions
among nonclinical samples (eg, university students who engage
in heavy drinking) is limited, with numerous studies showing
null results [20,26,35]. Further, meta-analyses that synthesizedfindings on the efficacy of these training programs among a
mixture of clinical RCTs and nonclinical experimental studies
produced similar inconclusive findings (eg, studies by Cristea
et al [26] and Cristea et al [27]), perhaps because of substantial
heterogeneity in study samples, designs, and methodologies
and variations in motivation to change alcohol use [20,36].
Indeed, it has been proposed that successful training effects
among participants in clinical RCTs may be due to greater
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may be a requisite for successful training effects, as opposed toparticipants in experimental laboratory studies [20].
To increase the clinical utility and scalability of IBM and ApBM
interventions, recent studies have begun investigating thefeasibility, acceptability, and efficacy of these programs when
delivered via the internet [37-39] or smartphone apps [40,41],
rather than in the laboratory or clinic. Both types oftechnology-based delivery methods have demonstrated
considerably good uptake of and adherence to training sessions[40-42]; however, they commonly experience substantial study
attrition [38,41,43]. With regard to preliminary efficacy, some
app-based IBM and ApBM programs have produced significant
within-group (from before to after the intervention) reductions
in alcohol consumption [41], relapse up to 3 months after
treatment [40], cravings and alcohol problem severity 1 monthafter training [40], and interpretation biases and social anxiety
after training compared with a control [44,45]. Other ApBM
apps have produced null effects on alcohol use or hazardous
drinking [46]. Likewise, web-based IBM programs have broadly
been efficacious in improving pre-to-post interpretation biases[37,39,42,43,47] and social anxiety symptoms [37,43] (eg, 48%
of participants no longer met the criteria for social anxiety
disorder after 8 IBM sessions) [37]. Meta-analyses haveconcluded that web-based IBM programs are efficacious, withno significant difference in efficacy between offline (eg, schoolor laboratory) and web-based modalities [24]. Althoughinternet-delivered ApBM has been associated withimprovementsindrinking
outcomes
among
nontreatment-seekers, equivalent reductions have been observed
among sham control training groups [38], thus producing
nondifferential effects between groups. Future research is needed
to integrate web-based ApBM with more traditional cognitiveand motivational interventions to improve results [38]. To
overcome challenges with attrition and enhance engagement,
clinical utility, and intrinsic motivation to complete
technology-based CBM training, past research also encouraged
theinclusionofapsychoeducational,
motivation-enhancement-type module before the first training
session [48].
Overall, evidence to date suggests that both IBM and ApBM
interventions possess the potential for having positive effects
on cognitive biases and social anxiety or alcohol symptoms,
particularly among clinical samples. However, it is unknown
whether web-based programs are effective among young
comorbid samples with clinical symptoms. Given that young
people prefer treatments offered via technology (eg, the internet
vs face to face) [49] and that the peak onset and disability
associated with anxiety and alcohol use disorders occur between
adolescence and early adulthood [50,51], the delivery of IBM
and ApBM programs via the internet to a clinical sample ofyoung adults may hold particular promise for training effects
on anxiety and alcohol use. In addition, a limitation of theexisting literature is the predominant focus on IBM and ApBM
in isolation of one another. Only 1 small study (N=86) examinedthe efficacy of CBM programs among people with comorbid
anxiety and alcohol use. Specifically, Clerkin and colleagues[52] examined the efficacy of an anxiety-focused andalcohol-focused attention bias CBM program (relative to an
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Prior et alanxiety or alcohol sham control) among a sample of adults withcomorbid social anxiety and alcohol dependence. The authors
found equivalent reductions between the intervention and control
conditions in attentional biases, alcohol use disorder, and social
anxiety [52]. They concluded that targeting attentional biases
alone, without addressing co-occurring biases, may not be ameaningful or clinically significant way to influence comorbid
anxiety and alcohol dependence. This aligns with the combined
cognitive bias hypothesis, which proposes that biased cognitive
processes often act in combination, and “targeting two biases
at the same time may enable more rigid cognitive structures tobecome more malleable” [53].
To better serve the needs of comorbid samples, we developed
an internet-delivered IBM+ApBM program for young adults
with co-occurring social anxiety and hazardous alcohol use(“Re-Train Your Brain”) and conducted an acceptability study
among young adults and clinicians to inform refinements to theintervention [48]. Feedback from both groups indicated that the
Re-Train Your Brain IBM+ApBM program was an acceptableand potentially clinically useful supplement to TAU [48]; afinding that aligns with previous CBM acceptability studies[54,55]. Despite some valuable feedback on the program, it
remains unclear how to incorporate training for both IBM and
ApBM. Specifically, it remains unknown whether the formatof the Re-Train Your Brain program would be most engaging
and efficacious if (1) IBM and ApBM tasks are integrated withineach session (ie, participants receive brief versions of both tasks
in a 50:50 ratio) or (2) IBM and ApBM tasks are alternatedbetween sessions (ie, participants receive full-length versionsof IBM in 1 training session and ApBM in the next training
session). The integrated format would provide more repeatedpractice with smaller gaps between rehearsals of each new skill(which is typically good for learning), but it is possible that thedose may be insufficient on each occasion to have carryover or
far transfer effects, thus potentially weakening the effects. It
may also be that integrating IBM and ApBM increases
engagement because users have more variety in training tasks
within each session, thus reducing boredom, which is a common
critique of CBM interventions [56,57]. However, regularswitching between training tasks may also create fatigue or
confusion. Further empirical research is needed to address thisresearch question and determine end user experiences.

Aims
The aim of this pilot RCT study was to evaluate whether theinternet-delivered Re-Train Your Brain IBM+ApBM
intervention is feasible, acceptable, and preliminarily efficacious
as an adjunct to TAU for young adults (aged 18-30 y) who are
currently experiencing co-occurring social anxiety disorder
symptoms and hazardous alcohol use. As part of this aim, thestudy assessed whether integrating or alternating the IBM and
ApBM training tasks was rated as more acceptable by users andwhich format demonstrated greater efficacy (primarily basedon estimated effect sizes, given that this pilot trial was not
powered to detect statistically significant effects).
It was hypothesized that both program formats would be feasible
to implement and would be deemed acceptable by young adults.
However, it was anticipated that the participants who receive
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the integrated format would be more engaged and exhibit larger
estimated effect sizes, given that the program delivery is morevaried within each session, potentially reducing the boredom
experienced because of repetitive tasks and thus boostingengagement. It was likely that both formats of the Re-Train
Your Brain program plus TAU would result in greater estimatedeffect sizes in cognitive biases as well as anxiety- andalcohol-related clinical outcomes over the study period,
compared with TAU only.

Prior et alindividually randomized on a 1:1:1 basis to receive (1) an“integrated” Re-Train Your Brain program, composed of 10
twice-weekly sessions containing brief versions of both IBM
and ApBM (50:50 ratio), plus TAU in accordance with standardpractice; (2) an “alternating” Re-Train Your Brain program,composed of 10 twice-weekly sessions containing 5 full-length
IBM sessions and 5 full-length ApBM sessions, delivered onalternate training days, plus TAU; or (3) TAU only. The
assessment end points were 6 weeks and 12 weeks after baseline.
Figure 1 depicts the study design.

Methods
Trial Design and Registration
The Re-Train Your Brain study was a 3-arm pilot RCT
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Figure 1. CONSORT (Consolidated Standards of Reporting Trials) diagram showing participant flow through the study. ApBM: approach bias
modification; IBM: interpretation bias modification; TAU: treatment as usual.

Ethical Considerations
The study was prospectively registered with the Australian New
Zealand Clinical Trials Registry (ACTRN12620001273976),
and ethics approval was granted by the University of Sydney’s
Human Research Ethics Committee (#2020/135).

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Participants and Recruitment
Overview
Participants were recruited between March 2021 and July 2022
via paid advertising and organic advertising (ie, unpaid, suchas posting or sharing of posts) on social media (eg, Facebook[Meta Platforms, Inc], Instagram [Meta Platforms, Inc], andTwitter [Twitter, Inc]), distribution of flyers at educational
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institutions, and referrals from youth services. On the basis ofseveral rules of thumb used to determine an appropriate sample
size for a pilot study [58-60], a sample size of 90 young people(30/arm) was selected to provide sufficient data on thefeasibility, acceptability, and preliminary efficacy of the
program.

Inclusion Criteria
To be eligible, participants were required to (1) be Australian
and aged 18 to 30 years; (2) currently report hazardous orharmful alcohol use, as indicated by a score of ≥8 on the Alcohol
Use Disorder Identification Test (AUDIT) [61]; (3) currently
experience at least mild symptoms of social anxiety, as indicatedby a score of ≥7 on the Social Interaction Anxiety Scale or ≥2on the Social Phobia Scale [62]; (4) have access to the internet
via a mouse-operable laptop or PC; (5) receive psychologicaltreatment from a mental health professional (eg, psychologist
or counselor) for anxiety, alcohol use problems, or both; and(6) be willing to complete the intervention components.

Exclusion Criteria
Owing to possible interference with the participant’s capacity
to engage with or understand the cognitive tasks, individuals
were excluded if they (1) were unable or unwilling to provide
contact details, that is, phone number and email address; (2)self-reported having poor English literacy; (3) had active
symptoms of psychosis, as indicated by a score of ≥3 on thePsychosis Screening Questionnaire [63]; (4) had a history ofneurological disease or head injury with a loss of consciousness
exceeding 30 minutes; (5) had an intellectual disability or
cognitive impairment; or (6) had eyesight that was not normal
or was corrected to normal (ie, using glasses or contact lenses).

Measures
The measures are summarized in the subsequent sections anddescribed in detail in the study protocol [64] and Multimedia
Appendix 1 [15,32,48,61,62,65-81].

Primary Outcome Measures
Feasibility
Feasibility of the research study was measured through theproportion of participants who provided consent, completed
follow-up surveys and/or cognitive assessments, and declined
or withdrew from the study. Feasibility of the intervention wasmeasured through the proportion of participants whocommenced training, completed all 10 training sessions, andcompleted the optimum number of 6 training sessions for
efficacy effects [65]; the number of sessions completed; andthe reporting of adverse events.
Acceptability
Usability of the program was assessed among the intervention
groups 6 weeks after baseline using the System Usability Scale[66-68], and satisfaction was measured using the 8-item Client
Satisfaction Questionnaire [69]. Acceptability was assessedusing 13 acceptability items (developed by the research team).
To determine which intervention delivery model was preferred,
the participants were asked 4 user experience items.

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Secondary Outcome Measures
The following measures were assessed at baseline, after
intervention, and 12 weeks after baseline. Multimedia Appendix
1 and the study protocol [64] provide a more detailed descriptionof each measure and its interpretation.
Cognitive Biases
Social anxiety interpretation biases were measured using theInterpretation Recognition Task [70,71]. Mean similarity ratings
for positive target interpretations and negative target
interpretations and an overall interpretation bias score were
calculated, with higher scores reflecting a stronger interpretation
bias [82,83]. Alcohol approach biases were assessed using thealcohol Approach Avoidance Task [15]. Scores were calculated
separately for alcohol- and non–alcohol-related stimuli, withhigher positive values indicating a stronger approach bias forthe relevant stimuli. As per previous literature (eg, the study by
Piercy et al [72]), to provide an index of alcohol approach bias
relative to non–alcohol-related bias, the non–alcohol approach
bias scores were then subtracted from the alcohol approach bias
scores. Comorbid interpretation biases for social anxiety andalcohol use were assessed using the self-report Comorbid Social
Anxiety and Alcohol Interpretation Bias task [73]. Higher scoresindicate a stronger comorbidity bias.
Anxiety and Alcohol Use
Social anxiety disorder symptoms were assessed at each time
point using the Social Interaction Anxiety Scale and Social
Phobia Scale–short forms [62], and generalized social anxiety
was measured using the Social Phobia Weekly Summary Scale[74]. Hazardous alcohol use was assessed via the AUDIT [61](score ≥8), whereas alcohol consumption (ie, number of drinks
per day) in the past month (plus alcohol consumption throughout
the intervention period) were assessed via the computerized
Timeline Follow-back Procedure [75-77]. Alcohol dependence
was assessed using the Severity of Alcohol Dependence
Questionnaire [78], and alcohol cravings was assessed using
the Severity of Alcohol Craving Questionnaire–Short
Form–Revised [79].
Additional Variables
Sociodemographic characteristics included age, sex, gender,
education, employment status, country of birth, and primarymental health or substance use concern. Psychological andpharmacological treatments received in the past 3 months werealso ascertained. Readiness and motivation to change anxiety
and alcohol were assessed via a readiness ruler and the
University of Rhode Island Change Assessment [80].

Intervention Groups: Re-Train Your Brain
Intervention Plus TAU
Overview
All the participants self-reported that they were currently
receiving treatment from a mental health professional foranxiety, alcohol use, or both (ie, TAU). The participants reported
predominantly seeing one or more of the following mental healthproviders: a general practitioner (63/100, 63%), psychologist(49/100, 49%), clinical psychologist (22/100, 22%), or counselor(21/100, 21%).
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Both Re-Train Your Brain interventions contained an IBM and
ApBM component as a supplement to TAU (Multimedia
Appendix 1). The participants received access to ten 20-minutetraining sessions over 5 weeks (approximately 2/wk). Before
training, the participants also received immediate access to a
web-based psychoeducation and motivational enhancement
module, which provided information about anxiety, alcohol use,
their interrelationship, the existence of cognitive biases, and theimportance of changing these biases. Within the module, theparticipants set goals for what they hoped to achieve bycompleting the training. The following is a description of the
IBM and ApBM training components.

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IBM for Social Anxiety
The participants were provided with a set of ambiguous social
scenarios consisting of 3 lines, presented on a computer screen(Figure 2). The final line of each scenario contained a word
fragment, and the participants were instructed to fill in the
missing letter using their keyboard. The word fragment always
resolved the ambiguity in a positive or neutral manner. Aftereach scenario, the participants responded (yes or no) to acomprehension question and received feedback (“correct” or“incorrect,” with a corresponding emoji). Points were awarded
for each correct letter and question response. The scenarios weregenerated specifically for Australian youth [48]. Three practice
trials were provided before the real training.

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Figure 2. Example interpretation bias modification scenario for illustrating the training procedures.

ApBM for Alcohol Use
The participants were instructed to pull or push a computer
mouse in response to the orientation of images containing
alcoholic or nonalcoholic beverages (eg, pull landscape andpush portrait), and the image size increased or decreased
accordingly (Figure 3). The participants received “gamified”

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feedback for correct (green “✔” plus smiley emoji) and incorrect
responses (red “X” plus sad emoji). Points were awarded foreach correct movement (+1) to enhance engagement andmotivation. The alcoholic and nonalcoholic images were basedon beverage types and brands commonly consumed by young
Australians [48].

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Figure 3. Example approach bias modification scenario for illustrating the training procedures.

Delivery Formats
The Re-Train Your Brain intervention was delivered in 2
formats.

Group 1: “Integrated” Re-Train Your Brain, With
Each Twice-Weekly Session Combining Both IBM and
ApBM
The participants received 10 training sessions composed ofshortened versions of both IBM and ApBM within each session(50:50 ratio, ie, 50% of the duration of each session for IBM
and 50% for ApBM, in random order) plus TAU. For IBM
training, the participants were presented with 3 blocks of 10
scenarios in each of the 10 sessions (ie, 300 across all sessions).
Each block contained 8 positive modification (“induction”)
scenarios and 2 filler scenarios, which served 2 functions: first,
as most but not all scenarios were positive, there was greater
ecological validity, as not all situations resolve positively indaily life; and second, by having some responses that were notpositive, the participant could not simply consistently choose
positive options for the comprehension questions. Instead, theparticipants had to read and process each scenario to select thecorrect answer to the comprehension question. This ensured
more elaborate processing of the training material, which would
be expected to strengthen the effects of training. The blocks
were in a fixed order, but the order of the scenarios within theblocks was random for each participant. For each ApBM
training, the participants were presented with 60 portrait orlandscape images containing a random selection of 20 alcoholicand 20 nonalcoholic beverages.

Group 2: “Alternating” Re-Train Your Brain, With
Twice-Weekly Sessions Alternating Between IBM and
ApBM
The participants in group 2 received the same treatment dose
as group 1; however, for each session, the participants received
full-length versions of either IBM or ApBM in an alternatingfashion (ie, 5 ApBM and 5 IBM sessions, in random order
between participants) plus TAU. For IBM training, theparticipants were presented with 6 blocks of 10 scenarios (ie,60 scenarios/session; 300 across the 5 IBM sessions). The
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content of the blocks mirrored that in group 1. For ApBM
training, the participants were presented with 120 portrait orlandscape images containing 20 alcoholic and 20 nonalcoholic
beverages (each image was presented 3 times).

Control Group (Group 3): TAU Only
The control group received TAU, which included standard carefrom their existing clinical provider. The participants wereplaced on a waitlist and were able to access the Re-Train Your
Brain program after the 12-week follow-up.

Procedure
Prospective participants were directed to the publicly available
Re-Train Your Brain website, provided consent, and completed
a 10-minute eligibility survey. Eligible participants completed
a 30-minute baseline survey, whereas ineligible participants
were provided with a list of referral options. The participants
who completed the baseline survey were posted a computer
mouse for the completion of a baseline cognitive assessment,with email and SMS text message reminders sent to encourage
completion.
Immediately following the cognitive assessment, the participants
were individually randomized on a 1:1:1 basis to receive (1)the “integrated” Re-Train Your Brain intervention plus TAU(35/100, 35%), (2) the “alternating” Re-Train Your Brainintervention plus TAU (32/100, 32%), or (3) TAU only (33/100,33%). Random allocation was performed independently throughthe trial website using a computer-generated randomization
sequence, which was concealed from the investigators. Owing
to the nature of the intervention, the participants and researchteam were not blinded to group allocation. The participants in
the intervention groups were given immediate access to themotivational interviewing, psychoeducational module and 2
training sessions per week (every 3-4 d). They were reminded
to complete the training via automated emails and SMS text
messages. To increase the motivation to complete the training,
the participants also received 3 to 4 brief motivational
enhancement texts or emails.
At the end of the intervention period (ie, 6 weeks after baseline,
allowing for 1 week of flexibility in the rate of training
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completion) and 12 weeks after baseline, the participants wereemailed and asked to complete a web-based follow-up survey
and subsequent cognitive assessment. These tasks took 45 to
60 minutes to complete, with an Aus $30 (US $19) e-gift
voucher as reimbursement at each time point. To minimize theimpact of participant attrition and maximize engagement withthe research trial, all the participants were asked to complete 2
weekly 5-minute assessments of their anxiety and alcohol use
symptoms, for which they received an Aus $5 (US $3) e-gift
voucher per occasion (10 total; maximum Aus $50 [US $32])
at the end of the intervention period.
The intervention and cognitive assessments were accessed via
the study website and run using JavaScript, whereas all surveys
were delivered via Qualtrics (Qualtrics International Inc). The
trial was conducted in accordance with the SPIRIT (Standard
Protocol Items: Recommendations for Interventional Trials)
2013 Statement and CONSORT (Consolidated Standards ofReporting Trials) guidelines.

Statistical Analysis and Power Calculations
Owing to the pilot nature of the study, a formal power
calculation was not conducted [84,85]. The current sample wasrecruited to provide data on the feasibility, acceptability, andpreliminary efficacy of the Re-Train Your Brain program anddetermine the expected effect size to inform the sample size ofa future RCT. Estimated effect sizes observed in this study
should, therefore, be interpreted with some degree of caution.
Descriptive analyses were performed on quantitative feasibility
and acceptability outcomes, and linear and logistic regressions
were conducted to investigate differences between theintervention groups. For qualitative feedback, a brief general
inductive analysis was carried out [86], which first involved aclose reading of the data by KP, who identified frequent,dominant, or significant quotes, which were then grouped
according to key themes. These themes were then discussedwith MP and refined based on discussion and consensus. Direct
quotations from the participants have been included to illustrate
key themes.
Efficacy analyses were conducted on an intention-to-treat basis
using Stata (version 16.0; StataCorp) [87], whereby allparticipants with complete baseline data were included,
regardless of intervention adherence. Multilevel mixed-effects
analyses were conducted on continuous dependent variables,and multilevel mixed-effects negative binomial regressions
were conducted on count-dependent variables (ie, number ofdrinks per day). These statistical techniques are rigorous
methods for modeling changes over time; they use all theavailable data and accommodate missing responses using
maximum likelihood estimation [88,89]. Normality assumptions
were examined, and sensitivity analyses with transformed data
were conducted when normality assumptions were violated. All
models used baseline measurements as the reference point toestimate participant-specific starting points and change over

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Prior et al
time. The intervention condition was represented bydummy-coded variables, and a condition by time interaction
was examined to assess between-group differences in outcomesover time. The most appropriate model and covariance structure
were determined using model fit statistics. The final models
included an estimation of random intercept and slope, used an
autoregressive error structure for within-person repeatedobservations over time, and modeled time as a categorical factor.
Cohen d was calculated from model-estimated β coefficientsand SEs to determine the between- and within-group effect sizes
at the relevant end points. Effect sizes were interpreted asfollows: ≥0.2=small effect, ≥0.5=medium effect, and ≥0.8=large
effect [90]. Owing to the preliminary nature of the study, which
is not powered for efficacy analyses, the results focus on themagnitude of effect rather than on statistical significance.

Results
Sample Characteristics
In total, 100 participants were recruited to the trial; Table 1 lists
their sociodemographic and clinical characteristics. The
participants were predominantly Australian-born (79/100, 79%)
female (76/100, 76%) individuals in their mid-20s (mean 26.44,
SD 2.82) who had a Bachelor's degree or higher education(54/100, 54%) and in full-time or part-time employment (72/100,72%). The participants’ primary concern was most frequently
reported to be generalized anxiety (54/100, 54%), with few
reporting social anxiety as their main clinical concern (3/100,3%). However, the majority reported high levels of social
anxiety at baseline, with 70% (70/100) meeting both 6-item
Social Interaction Anxiety Scale and 6-item Social Phobia Scalecriteria for a possible diagnosis of social anxiety disorder. The
sample also reported high levels of alcohol use, with a mean
past month consumption of 61.61 (SD 71.93) standard drinks
and 61% (61/100) reporting AUDIT scores indicative of
probable alcohol dependence (scores≥26). It should be notedthat although alcohol use was quite high, a sizable proportion(34/100, 34%) reported having 0 drinks in the past month (whichappeared to differ between groups: control: 8/33, 24%;integrated intervention: 18/35, 51%; alternating intervention:
8/32, 25%). Over three-quarters (65/100, 65%) of the sample
had an interpretation threat bias, whereas 59% (59/100) had an
alcohol approach bias (relative to an avoidance bias), with few
differences across the 3 groups. Overall, the sample had anequivalent approach bias for alcohol cues relative to nonalcohol
cues (mean 1.52, SD 187.72). The participants werepredominantly seeing a general practitioner (63/100, 63%) ora psychologist (49/100, 49%) at the time of the baseline survey,
and over two-thirds (67/100, 67%) were currently taking
medication for anxiety or alcohol use problems. They reported
being very ready to change their anxiety (mean 9.07, SD 1.01)
and moderately to very ready to change their alcohol use (mean7.35, SD 2.41).

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Table 1. Baseline sociodemographic and clinical characteristics, overall and by study group.
Integrated Re-Train Your

Alternating Re-Train Your
Brain + TAU (n=32)

TAU control (n=33)

Overall (N=100)

Brain + TAUa (n=35)
Age (y), mean (SD)26.51 (0.49)

26.47 (2.88)

26.33 (2.72)

26.44 (2.82)

Sex (female), n (%)

27 (77)22 (69)27 (82)76 (76)

Secondary school qualification

6 (17)

5 (16)

10 (30)21 (21)

Trade certificate or apprenticeship

5 (14)

2 (6)

3 (9)

10 (10)

Other tertiary education

6 (17)

5 (16)

4 (12)

15 (15)

Bachelor’s degree or higher

18 (51)20 (62)16 (48)54 (54)

Employed full time

17 (49)13 (41)16 (48)46 (46)

Employed part time or casually

11 (31)9 (28)

6 (18)

26 (26)Full-time home duties

0 (0)

1 (3)

0 (0)

1 (1)

Self-employed

1 (3)

1 (3)

1 (3)

3 (3)

Full-time student

4 (11)

5 (16)

6 (18)

15 (15)

Unemployed

2 (6)

3 (9)

4 (12)

9 (9)Australian born, n (%)

28 (80)25 (78)26 (79)79 (79)Generalized anxiety

19 (54)14 (44)21 (64)54 (54)Social anxiety

1 (3)

0 (0)

2 (6)

3 (3)

Trauma4 (11)

3 (9)

2 (6)

9 (9)

Depression

5 (14)

8 (25)

7 (21)

20 (20)Alcohol use

4 (11)

5 (16)

1 (3)

10 (10)

Other drug use

2 (6)

2 (6)

0 (0)

4 (4)

Anxiety interpretation bias, n (%)

24 (69)23 (72)18 (55)65 (65)

Alcohol approach bias, n (%)

21 (60)18 (56)20 (61)59 (59)Possible diagnosis of social anxiety disorder 22 (63)

22 (69)26 (79)70 (70)32 (100)

33 (100)

100 (100)

76.88 (81.02)

59.94 (60.15)

61.61 (71.93)

Highest education obtained, n (%)

Employment status, n (%)

Primary concern (self-reported), n (%)

Social anxiety severity, n (%)(SIAS-6b)
Possible diagnosis of social anxiety disorder 35 (100)(SPS-6c)
Total number of drinks in the past month, mean 49.23 (72.76)(SD)
Hazardous alcohol use severityd, n (%)
Medium level

7 (20)

4 (12)

7 (21)

18 (18)High level

10 (29)5 (16)

6 (18)

21 (21)

Probable dependence

18 (51)23 (72)20 (61)61 (61)

3 (9)

2 (6)

7 (21)

12 (12)Other illicit drug use (weekly or greater), n (%) 0 (0)

0 (0)

2 (6)

2 (2)

Nonmedical benzodiazepine use (weekly or
greater), n (%)

1 (3)

2 (6)

2 (6)

6 (6)

Readiness to change anxiety, mean (SD)9.34 (1.14)

9.19 (1.31)

8.67 (1.69)

9.07 (1.01)

Readiness to change alcohol, mean (SD)8.06 (1.98)

7.25 (2.37)

6.70 (2.72)

7.35 (2.41)

10.53 (1.48)

9.79 (1.51)

10.11 (1.65)

10.15 (1.57)

Cannabis use (weekly or greater), n (%)

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Integrated Re-Train Your
Brain + TAUa (n=35)

Alternating Re-Train Your
Brain + TAU (n=32)

TAU control (n=33)

Overall (N=100)

Treatment from a health professional for anxiety or alcohol in past 3 months, n (%)
Counselor

4 (11)

4 (12)

13 (39)21 (21)

Psychologist

24 (69)15 (47)

10 (30)49 (49)Clinical psychologist

7 (20)

6 (19)

9 (27)

22 (22)

General practitioner

24 (69)20 (62)19 (58)63 (63)

Psychiatrist

4 (11)3 (9)

6 (18)

13 (13)

Hospital inpatient admissions

2 (6)

2 (6)

1 (3)

5 (5)

Inpatient or residential treatment

1 (3)

0 (0)

1 (3)

2 (2)

Emergency department visits

3 (9)4 (12)

1 (3)

8 (8)

Other

1 (3)

0 (0)

3 (9)

4 (4)

Medication for anxiety or alcohol in past 3 monthsaAny medication, n (%)

22 (63)21 (66)24 (73)67 (67)

Number of medications, mean (SD)0.97 (0.99)

1.03 (0.93)

1.24 (1.00)

1.08 (0.97)

TAU: treatment as usual.

b

SIAS-6: 6-item Social Interaction Anxiety Scale.

c

SPS-6: 6-item Social Phobia Scale.

d

For descriptive purposes, Alcohol Use Disorder Identification Test hazardous alcohol use total scores are grouped here according to categories ofincreasing alcohol risk, from medium level (scores 8-15) to high level (scores 16-19) to indication for alcohol dependence (scores of ≥20).
e

URICA: University of Rhode Island Change Assessment Scale.

Despite random allocation to conditions, eyeballing thedescriptive statistics revealed several chance differences inbaseline characteristics between the groups. Compared with thecontrol group, the integrated Re-Train Your Brain group
appeared to have lower social anxiety scores, higher readinessto change anxiety, and higher alcohol use scores and were lesslikely to have seen a counselor and more likely to have seen a
psychologist over the past 3 months. They were also more likely
to have had 0 drinks in the past month. Compared with thecontrol group, the alternating Re-Train Your Brain group
appeared to be more likely to have ever used cannabis and lesslikely to have seen a counselor over the past 3 months.
Compared with the alternating Re-Train Your Brain group, theintegrated Re-Train Your Brain group had lower social anxiety

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scores. As per the CONSORT 2010 guidelines, no tests of thesignificance of baseline differences between the groups wereconducted [91]; however, these baseline differences wereaccommodated within the analyses, which modeled changes
over time from participant-specific starting points estimatedusing baseline measurements. In response to an honesty screener[92], 99% (99/100) of the participants reported that their survey
responses were truthful.

Primary Outcomes
Overview
Feasibility and acceptability outcomes are listed in Table 2 anddetailed in the subsequent sections.

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Table 2. Primary outcomes by group at 6-week and 12-week follow-up assessments.
Integrated Re-Train Your

Alternating Re-Train Your
Brain + TAU (n=32)

TAU control (n=33)

Brain + TAUa (n=35)

6-week follow-up

26 (74)19 (59)30 (91)

12-week follow-up

24 (69)16 (50)27 (82)6-week follow-up

25 (71)18 (56)28 (85)12-week follow-up

23 (66)

14 (44)25 (76)6-week follow-up

2 (6)

1 (3)

0 (0)

12-week follow-up

2 (6)

2 (6)

0 (0)

Completed psychoeducational module, n (%)

27 (77)24 (75)

N/Ab

Commenced training, n (%)

28 (80)26 (81)

N/A

Number of sessions completed, mean (SD)5.69 (4.28)

5.28 (4.04)

N/A

Completed the optimum of 6 training sessions, n (%)

19 (54)14 (44)

N/A

Completed all 10 training sessions, n (%)

14 (40)11 (34)

N/A

Adverse events (at 6-week follow-up), n (%)

4 (11)0 (0)5 (15)

Program usability (SUSc), mean (SD)85.40 (11.17)

82.11 (12.97)

N/A

Client satisfaction (CSQd), mean (SD)24.08 (4.99)

25.63 (5.12)

N/A

Completed follow-up survey, n (%)

Completed follow-up survey and games, n (%)

Study withdrawals, n (%)

a

TAU: treatment as usual.

b

N/A: not applicable.

c

SUS: System Usability Scale.

d

CSQ: Client Satisfaction Questionnaire.

Feasibility
Study Feasibility
Figure 1 illustrates the flow of participants through the study
phases. Of the 706 patients who were screened for eligibility,
3 (0.4%) did not provide consent, 238 (33.7%) did not complete
the screener, and 225 (31.9%) did not meet the inclusion criteria.
Of the 240 (34%) eligible participants, 138 (57.5%) completed
the baseline survey, of whom 100 (72.5%) then completed thesubsequent cognitive assessment and were randomized (ie,100/240, 41.7% of eligible individuals). Recruitment ceased
after randomizing 100 participants. A total of 73 (73%)
participants provided survey and cognitive assessment data forat least 1 of the 2 follow-up time points; the 6-week survey wascompleted by 75% (75/100) of the participants, and 71%(71/100) completed the 6-week cognitive assessment. The rates
of completion of both 6-week tasks were significantly different
between the control and alternating Re-Train Your Brain groups(odds ratio [OR] 0.23, 95% CI 0.07-0.75; P=.02) but not
between the integrated group and the control or alternating
Re-Train Your Brain group (OR 0.45, 95% CI 0.13-1.45; P=.19;
OR 1.94, 95% CI 0.71-5.35; P=.20). At the 12-week follow-up,
67% (67/100) of the participants completed the survey, whereas
62% (62/100) of the participants completed both the survey andcognitive assessment. The rate of completion of at least 1
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control (30/33, 91%) and alternating intervention (18/32, 56%;
OR 0.01, 95% CI 0.03-0.51; P=.004) groups, whereas no
significant differences were evident between the integrated
group (25/35, 71%) and either the control or alternating group(OR 0.25, 95% CI 0.06-1.01; P=.051; OR 1.94, 95% CI
0.71-5.35; P=.19). No differences in the baselinesociodemographic or clinical characteristics were identified
between those who were lost to follow-up and those who were
not. Across the study, of the 100 participants, only 4 (4%)
actively withdrew their consent; 3 (3%) withdrew from both
follow-up occasions, and 1 (1%) withdrew from the 12-weekfollow-up only. None of them asked to withdraw their data. No
significant differences in withdrawals were observed between
the groups (P<.05). Overall, these findings suggest that the
study was feasible.
Intervention Feasibility
Among the 67 participants in the intervention groups, overthree-quarters (n=51, 76%) completed the psychoeducationalanxiety-alcohol module, and 81% (n=54) completed at least 1
training session, with an average of 5.49 (SD 4.14) sessions
completed. No significant differences were found between the
integrated and alternating Re-Train Your Brain groups in module
completion (OR 1.13, 95% CI 0.37-3.46; P=.84), training
commencement (OR 0.92, 95% CI 0.27-3.11; P=.90), or thenumber of sessions completed (β=.40, 95% CI –1.63 to 2.44;
P=.69). Nearly half (33/67, 49%) of those in the intervention
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JMIR FORMATIVE RESEARCH
groups completed the optimum dose of 6 training sessions, and
1 in 3 (25/67, 37%) completed all 10 sessions (25/54, 46% of
those who completed at least 1 training session). There wereno significant differences in the rate of completing 6 training
sessions (OR 1.53, 95% CI 0.58-4.01; P=.39) or all 10 sessions(OR 1.28, 95% CI 0.47-3.44; P=.52) between the integrated
and alternating intervention groups.
Adverse Events
When asked about adverse events at the 6-week assessment, of
the 75 participants who completed the survey, 9 (12%) reported
negative or adverse effects during the intervention period (n=4,
44% in the integrated Re-Train Your Brain group and n=5, 55%
in the control group); however, all these participants explicitly
attributed the adverse event to reasons or circumstances external
to the Re-Train Your Brain program (n=7, 78% attributed thisto TAU and n=2, 22% to other reasons). No serious adverse
events or adverse events were reported in the open feedbackquestions or spontaneously reported to the study team.

Acceptability
Usability
The mean System Usability Scale score across the intervention
groups was 83.98 (SD 11.95), which was the highest possible
rating and equivalent to an “A” grade. There were no significant
differences in the System Usability Scale scores based ondelivery modality (ie, integrated vs alternating; β=3.30, 95%
CI –4.06 to 10.65; P=.37).
Satisfaction
The mean 8-item Client Satisfaction Questionnaire score wasmoderate to high at 24.75 (SD 5.05), with no significant
differences in scores between the integrated and alternating
Re-Train Your Brain groups (β=−1.55, 95% CI –4.65 to 1.55;
P=.32).
Acceptability
The vast majority of the 67 participants in the intervention
groups indicated that the program they completed was
acceptable (n=59, 88%), user-friendly (n=61, 91%), credible(n=58, 87%), simple (n=64, 96%), and easy to complete (n=61,91%). Three-quarters (50/67, 75%) said that they could see thepotential value and effectiveness of the intervention. Conversely,
fewer participants deemed the program to be enjoyable (37/67,55%), motivating (29/67, 43%), logical (43/67, 64%), engaging(26/67, 39%), likely to be effective in reducing anxiety andalcohol use (38/67, 57%), and helpful in practicing the skills
learned in TAU (35/67, 52%). Half (34/67, 51%) of theparticipants also reported that the training tasks took up too

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Prior et almuch time. No significant differences were found between the
integrated and alternating groups on 3 of the 4 user experience
items, including motivation to train (11/35, 31% vs 11/32, 34%;
OR 0.87, 95% CI 0.56-1.35; P=.53), training enjoyment (13/35,
37% vs 9/32, 28%; OR 1.36, 95% CI 0.87-2.12; P=.17), anddelivery of training (17/35, 49% vs 16/32, 50%; OR 0.96, 95%
CI 0.64-1.45; P=.85). However, the integrated group was lesslikely than the alternating group to rate their training as “veryor extremely” simple and user-friendly (26/35, 74% vs 29/32,
91%; OR 0.37, 95% CI 0.21-0.67; P<.001).
Most and Least Helpful Components
The ApBM training was often reported to be fun, especiallywhen trying to complete the tasks quickly:
The picture game was a good challenge to do as fast
as possible. [#3637]
The IBM training, by contrast, was commonly reported as themost helpful component of the intervention and had practical
implications:
The anxiety training gave me a new perspective inviewing my thoughts. [#1260]
I could tell from the anxiety section of the programthat it was training your brain to consider all options
as opposed to only catastrophic ones...I actually havestarted practicing addressing any anxious thoughts
I have about how I am perceived by others. [#1145]
The participants also indicated that they found the twice-weekly
check-in assessments of their anxiety and alcohol consumption
useful for accountability and to reflect on:
Having to interrogate and track my drinking habits
and calculate how many drinks I’d consumed overthe past week. [#4717]
The team also received unsolicited feedback (via text) indicating
the impact of the Re-Train Your Brain intervention:
I’ve been very grateful to be involved in thisstudy...[the training] has supported me in beginningto limit my alcohol intake and even take on the ideaof going sober completely! [#4801]

Secondary Outcomes
Overview
Table 3 provides descriptive statistics of the cognitive andclinical variables, and Tables 4 and 5 summarize the efficacy
findings and their associated effect sizes.

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Table 3. Secondary outcomes by group at baseline and 6-week and 12-week follow-up assessments.
Integrated Re-Train Your Brain+ TAUa (n=35), mean (SD)

Alternating Re-Train Your Brain+ TAU (n=32), mean (SD)TAU control (n=33),
mean (SD)

Baseline

0.24 (0.64)

0.31 (0.61)

0.21 (0.77)

6-week follow-up−0.75 (0.79)−0.75 (0.76)

0.25 (0.77)

12-week follow-up−0.20 (0.25)−0.19 (0.47)−0.11 (0.27)

Baseline

2.42 (0.40)

2.44 (0.50)

2.48 (0.50)

6-week follow-up

2.82 (0.50)

2.88 (0.48)

2.32 (0.48)

12-week follow-up

2.86 (0.43)

2.94 (0.37)

2.51 (0.46)

Baseline

2.66 (0.54)

2.75 (0.51)

2.69 (0.70)

6-week follow-up

2.07 (0.52)

2.13 (0.42)

2.57 (0.71)

12-week follow-up

2.66 (0.36)

2.75 (0.43)

2.40 (0.45)

Baseline

24.96 (121.42)

14.13 (193.16)

48.26 (138.89)

6-week follow-up−4.26 (101.83)

9.75 (82.07)

33.61 (137.60)

12-week follow-up

34.89 (98.61)−16.23 (131.29)−7.48 (164.56)

Anxiety interpretation bias (IREC-Tb)

Positive target interpretation (IREC-T)

Negative target interpretation (IREC-T)

Alcohol approach bias (AATc)

Comorbid social anxiety and alcohol interpretation bias
Baseline

3.07 (1.48)

3.31 (1.40)

2.92 (1.46)

6-week follow-up

2.47 (1.50)

2.68 (1.52)

2.53 (1.42)

12-week follow-up

2.00 (1.69)

2.18 (1.31)

2.68 (1.49)

Baseline

17.91 (8.21)

22.88 (10.76)

23.12 (11.17)

6-week follow-up

17.73 (9.85)

19.68 (10.39)

20.87 (10.46)

12-week follow-up

15.38 (8.26)

18.44 (8.20)

22.07 (9.66)

Baseline

4.45 (1.39)

4.92 (1.47)

4.88 (1.39)

6-week follow-up

3.98 (1.65)

3.73 (1.93)

4.34 (1.66)

12-week follow-up

3.48 (1.39)

2.91 (1.84)

4.24 (1.78)

Social anxiety (SIAS-6d and SPS-6e)

Generalized social anxiety (SPWSSf)g

Number of drinks per day in the past month (TLFB )Baseline

1.64 (2.43)

2.56 (2.70)

2.00 (2.00)

6-week follow-up

2.52 (2.26)

2.70 (2.65)

2.50 (2.19)

3.07 (4.22)

2.15 (1.94)

2.34 (2.19)

Baseline

21.46 (6.49)

22.94 (6.56)

21.33 (5.99)

6-week follow-up

17.73 (8.39)

17.63 (9.48)

17.47 (6.73)

15.54 (9.38)

14.19 (8.80)

17.37 (7.76)

Baseline

3.59 (1.07)

3.53 (1.29)

3.55 (1.14)

6-week follow-up

2.97 (1.12)

2.35 (1.36)

3.34 (1.34)

12-week follow-up

2.31 (1.02)

2.33 (0.49)

2.73 (0.90)

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Integrated Re-Train Your Brain+ TAUa (n=35), mean (SD)

Alternating Re-Train Your Brain+ TAU (n=32), mean (SD)TAU control (n=33),
mean (SD)

Baseline

19.49 (10.61)

19.06 (9.13)

18.42 (12.36)

6-week follow-up

16.42 (13.31)

13.53 (10.55)

15.33 (11.31)

12-week follow-up

14.21 (10.73)

12.38 (9.71)

17.04 (12.84)

Alcohol dependence (SADQj)a

TAU: treatment as usual.

b

IREC-T: Interpretation Recognition Task.

c

AAT: Alcohol Approach Task.

d

SIAS-6: 6-item Social Interaction Anxiety Scale.

e

SPS-6: 6-item Social Phobia Scale.

f

SPWSS: Social Phobia Weekly Summary Scale.

g

TLFB: Timeline Follow-back Procedure.

h

AUDIT: Alcohol Use Disorder Identification Test.

i

ACQ: Severity of Alcohol Craving Questionnaire–Short Form–Revised.

j

SADQ: Severity of Alcohol Dependence Questionnaire.

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Table 4. Mixed models for repeated measures fitted to cognitive bias outcomes with time period and groupa.
Outcomes

Baseline to 6-week follow-up

Baseline to 12-week follow-up

β (95% CI)

Cohen dP valueβ (95% CI)

Cohen dP value

Integrated Re-Train−.99 (−1.29 to −.70)

1.48

<.001

−.44 (−.77 to −0.11)

0.66

.01

Alternating Re-Train−1.08 (−1.42 to −.75) 1.61<.001−.51 (−.90 to −.13)

0.76

.01

Control.04 (−.25 to .32)

.81−.30 (−.63 to .03)

0.44

.08

Anxiety interpretation bias (IREC-Tb)
Time effect

0.05

Group × time interaction
Integrated Re-Train vs control−1.03 (−1.44 to −.62) 1.53<.001−.14 (−.61 to .32)

0.21

.55

Alternating Re-Train vs control−1.12 (−1.56 to −.68) 1.67<.001−.21 (−.72 to .29)

0.32

.40

Integrated Re-Train vs alternating Re-Train.09 (−.36 to .54)

0.14

.69

.07 (−.43 to .58)

0.11

.78

Integrated Re-Train.40 (.23 to .58)

0.87

<.001

.45 (.25 to .64)

0.97

<.001

Alternating Re-Train.46 (.25 to .66)

0.99

<.001

.54 (.31 to .78)

1.18

<.001

Control−.14 (−.31 to .02)

0.31

.09

.01 (−.18 to .20)

0.02

.91

Integrated Re-Train vs control.54 (.30 to.79)

1.18

<.001

.44 (.16 to .71)

0.94

.002

Alternating Re-Train vs control.60 (.34 to .86)

1.30

<.001

.53 (.23 to .84)

1.16

.001

Integrated Re-Train vs alternating Re-Train−.06 (−.32 to .21)

0.12

.68

−.10 (−.40 to .21)

0.21

.53

Integrated Re-Train−.59 (−.82 to −.36)

1.00

<.001

.01 (−.22 to .24)

0.02

.93

Alternating Re-Train−.64 (−.91 to −.38)

1.10

<.001

−.02 (−.30 to .25)

0.04

.87

Control−.12 (−.34 to .10)

0.20

.29

−.27 (−.50 to −.04)

0.46

.02

Integrated Re-Train vs control−.47 (−.79 to −.15)

0.80

.004

.28 (−.05 to .61)

0.48

.09

Alternating Re-Train vs control−.52 (−.87 to −.18)

0.89

.003

.25 (−.11 to .61)

0.42

.18

Integrated Re-Train vs alternating Re-Train.05 (−.29 to .40)

0.09

.76

−.03 (−.33 to .39)

0.06

.86

Integrated Re-Train−33.26 (−93.80 to27.28)

0.22.28

10.86 (−56.99 to
78.70)

0.07.75

Alternating Re-Train−6.45 (−75.71 to
62.80)

0.04.86−23.87 (−103.69 to
55.96)

0.16.56

Control−17.45 (−75.98 to
41.09)

0.12.56−57.99 (−124.51 to
8.52)

0.38

.09

Integrated Re-Train vs control−15.81 (−100.02 to
68.40)

0.10.71

68.85 (−26.17 to
163.86)0.45.16Alternating Re-Train vs control

10.99 (−79.69 to
101.68)0.07.8134.13 (−69.78 to
138.04)0.22.52

Integrated Re-Train vs alternating Re-Train−26.80 (−118.79 to
139.18)0.18.57

34.72 (−34.01 to
139.49)0.23.52

Positive target interpretation (IREC-T)
Time effectGroup × time interaction

Negative target interpretation (IREC-T)
Time effectGroup × time interaction

Alcohol approach bias (AATc)
Time effectGroup × time interaction

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JMIR FORMATIVE RESEARCH
Outcomes

Prior et alBaseline to 6-week follow-up

Baseline to 12-week follow-up

β (95% CI)

Cohen dP valueβ (95% CI)

Cohen dP value

Integrated Re-Train−25.01 (−92.21 to
42.19)

0.12.47−10.45 (−91.12 to70.23)

0.05.80

Alternating Re-Train

36.74 (−40.56 to
114.04)0.17.3254.77 (−40.02 to
149.56)0.26.28

Control−30.91 (−95.47 to
33.65)

0.15.35−62.62 (−141.49 to
16.25)

0.30.12Integrated Re-Train vs control

5.90 (−87.29 to 99.09) 0.03

.90

52.17 (−60.65 to
165.00)0.25.37Alternating Re-Train vs control

67.65 (−33.07 to
168.37)0.32.19117.39 (−5.93 to
240.70)0.56.06

Integrated Re-Train vs alternating Re-Train−61.75 (−164.18 to40.68)

0.29.24−65.21 (−189.69 to
59.26)

0.31.30

Non–alcohol approach bias (AAT)Time effectGroup × time interaction

Comorbid social anxiety and alcohol interpretation bias
Time effectIntegrated Re-Train−.68 (−1.05 to −.30)

0.47

<.001

−1.17 (−1.66 to −.68) 0.81<.001

Alternating Re-Train−.62 (−1.05 to −.18)

0.43

.005

−1.10 (−1.67 to −.52) 0.76<.001

Control−.40 (−.76 to −.05)

0.28

.02

−.35 (−.81 to .12)

0.24

.14

Integrated Re-Train vs control−.27 (−.79 to .24)

0.19

.30

−.83 (−1.50 to −.15)

0.57

.02

Alternating Re-Train vs control−.21 (−.77 to .35)

0.15

.46

−.75 (−1.49 to −.01)

0.52

.048

Integrated Re-Train vs alternating Re-Train−.06 (−.63 to .51)

0.04

.83

−.08 (−.84 to .68)

0.05

.84

Group × time interactionaAll 3 groups received treatment as usual.

b

IREC-T: Interpretation Recognition Task.

c

AAT: Alcohol Approach Task.

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JMIR FORMATIVE RESEARCH

Prior et al

Table 5. Mixed models for repeated measures fitted to clinical outcomes with time period and intervention groupa.
Outcomes

Baseline to 6-week follow-up

Baseline to 12-week follow-up

β (95% CI)

Cohen d P value

β (95% CI)

Cohen d P value

Social anxiety disorder symptoms (SIAS-6b and SPS-6c)
Time effectIntegrated Re-Train−.46 (−3.32 to 2.41)

0.04

.76

−2.73 (−6.10 to .65)

0.27

.11

Alternating Re-Train−3.01 (−6.30 to .28)

0.29

.07

−4.55 (−8.55 to −.56)

0.44

.03

Control−1.87 (−4.57 to .83)

0.18

.17

−1.00 (−4.22 to 2.22)

0.10

.54

Integrated Re-Train vs control

1.42 (−2.52 to 5.35)

0.14

.48

−1.73 (−6.39 to 2.94)

0.17

.47

Alternating Re-Train vs control−1.14 (−5.39 to 3.12)

0.11

.60

−3.56 (−8.69 to 1.58)

0.35

.18

Integrated Re-Train vs alternating Re-Train

2.55 (−1.81 to 6.91)

0.25

.25

1.83 (−3.40 to 7.06)

0.18

.49

Integrated Re-Train−.45 (−.97 to .06)

0.32

.08

−1.01 (−1.60 to −.42)

0.71

.001

Alternating Re-Train−1.01 (−1.60 to −.41) 0.71

.001

−1.89 (−2.59 to −1.18)

1.33

<.001

Control−.57 (−1.06 to −.08)

0.40

.02

−.71 (−1.26 to −.15)

0.50

.01

Integrated Re-Train vs control.12 (−.59 to .83)

0.08

.75

−.30 (−1.11 to .51)

0.21

.46

Alternating Re-Train vs control−.43 (−1.20 to .33)

0.31

.27

−1.18 (−2.08 to −.28)

0.83

.01

Integrated Re-Train vs alternating Re-Train.55 (−.24 to 1.34)

0.39

.17

.88 (−.04 to 1.79)

0.62

.06

Integrated Re-Train

1.38 (.93 to 2.07)

0.58

.11

1.33 (.80 to 2.22)

0.56

.27

Alternating Re-Train

1.08 (.71 to 1.66)

0.45

.71

.83 (.46 to 1.51)

0.60

.55

Control

1.19 (.82 to 1.71)

0.49

.36

.92 (.57 to 1.48)

0.38

.73

Integrated Re-Train vs control

1.16 (.68 to 2.0)

0.49

.57

1.45 (.73 to 2.85)

0.60

.29

Alternating Re-Train vs control.91 (.53 to 1.60)

0.38

.75

.90 (1.21 to 2.39)

0.38

.79

Integrated Re-Train vs alternating Re-Train

1.8 (.71 to 2.29)

0.53

.41

1.60 (.74 to 3.44)

0.67

.23

Integrated Re-Train−3.59 (−5.78 to−1.41)

0.57.001−6.18 (−9.29 to −3.07)

0.98

<.001

Alternating Re-Train−4.70 (−7.21 to−2.19)

0.74

<.001

−7.29 (−10.96 to −3.63) 1.15<.001

Control−3.94 (−5.99 to−1.88)

0.62

<.001

−4.52 (−7.47 to −1.57)

0.71

.003

Integrated Re-Train vs control.34 (−2.66 to 3.35)

0.05

.82

−1.66 (−5.95 to 2.62)

0.26

.45

Alternating Re-Train vs control−.76 (−4.01 to 2.49)

0.12

.65

−2.78 (−7.48 to 1.92)

0.44

.25

Integrated Re-Train vs alternating Re-Train

1.10 (−2.23 to 4.43)

0.17

.52

1.12 (−3.69 to 5.92)

0.18

.65

Group × time interaction

Generalized social anxiety (SPWSSd)
Time effectGroup × time interaction

Average number of drinks per day (TLFB)e,f
Time effectGroup × time interaction

Hazardous alcohol use (AUDITg)
Time effectGroup × time interaction

Severity of dependence (SADQh)
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JMIR FORMATIVE RESEARCH
Outcomes

Prior et alBaseline to 6-week follow-up

Baseline to 12-week follow-up

β (95% CI)

β (95% CI)

Cohen d P value

Cohen d P value

Integrated Re-Train−3.72 (−6.76 to −.69) 0.35

.02

−6.61 (−10.13 to −3.09) 0.62<.001

Alternating Re-Train−5.58 (−9.07 to−2.08)

0.52.002−6.38 (−10.57 to −2.19) 0.60

.003

Control−2.83 (−5.69 to .03)

0.26

.05

−2.07 (−5.42 to 1.27)

0.19

.23

Integrated Re-Train vs control−.89 (−5.06 to 3.28)

0.08

.67

−4.54 (−9.39 to .32)

0.42

.07

Alternating Re-Train vs control−2.75 (−7.26 to 1.77)

0.26

.23

−4.31 (−9.66 to 1.05)

0.40

.12

Integrated Re-Train vs alternating Re-Train

1.85 (−2.78 to 6.48)

0.17

.43

−.23 (−5.70 to 5.24)

0.02

.93

Integrated Re-Train−.62 (−1.06 to −.17)

0.53

.007

−1.27 (−1.81 to −.74)

1.10

<.001

Alternating Re-Train−1.18 (−1.69 to −.67) 1.02<.001

−1.24 (−1.86 to −.62)

1.07

<.001

Control−.24 (−.67 to .18)

0.21

.26

−.91 (−1.43 to −.39)

0.79

.26

Integrated Re-Train vs control−.37 (−.99 to .24)

0.32

.24

−.36 (−1.11 to .38)

0.31

.34

Alternating Re-Train vs control−.94 (−1.60 to −.28)

0.81

.005

−.33 (−1.14 to .48)

0.28

.43

Integrated Re-Train vs alternating Re-Train.57 (−.11 to 1.24)

0.49

.10

−.03 (−0.85 to .78)

0.03

.94

Group × time interaction

Alcohol craving (ACQi)
Time effectGroup × time interactionaAll 3 groups received treatment as usual.

b

SIAS-6: 6-item Social Interaction Anxiety Scale.

c

SPS-6: 6-item Social Phobia Scale.

d

SPWSS: Social Phobia Weekly Summary Scale.

e

TLFB: Timeline Follow-back Procedure.

fCount data; incidence rate ratios (95% CI) is presented instead of β (95% CI).

g

AUDIT: Alcohol Use Disorder Identification Test.

h

SADQ: Severity of Alcohol Dependence Questionnaire.

i

ACQ: Severity of Alcohol Craving Questionnaire–Short Form–Revised.

Cognitive Biases
Interpretation Biases
Both Re-Train Your Brain groups showed large reductions ininterpretation biases from baseline to 6 weeks and moderate tolarge reductions in interpretation biases from baseline to 12
weeks. No changes were evident over time in the control group.
Both intervention groups experienced a greater reduction thanthe control group in interpretation biases from baseline to 6
weeks, but these improvements did not sustain until 12 weeks.
There were large increases in positive interpretations frombaseline to 6 weeks, and these gains were sustained until 12
weeks. Positive interpretations increased more in bothintervention groups relative to the control group, from baseline
to both follow-up time points. For negative interpretations, alarge reduction was evident from baseline to 6 weeks for bothintervention groups, and a small to moderate reduction wasevident from baseline to 12 weeks for the control group. Bothintervention groups showed greater reductions in negativeinterpretations than the control group from baseline to 6 weeks.
There were no differences between the Re-Train Your Braingroups on interpretation biases.
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Alcohol Approach Biases
There was no change over time or differences between thegroups in change over time with regard to alcohol approach
biases or non–alcohol approach biases.
Comorbid Interpretation Biases
A small to moderate reduction was apparent across all groups
at 6 weeks. For the Re-Train Your Brain groups, these reductions
remained at 12 weeks, whereas these improvements were notsustained by the control. Both intervention groups experienced
reduced comorbidity biases compared with the control groupat 12 weeks, with moderate effect sizes. Effects of bothintervention groups were comparable over time.

Anxiety and Alcohol Use
Social Anxiety
The alternating Re-Train Your Brain group experienced a small
to moderate reduction in social anxiety from baseline to 12
weeks; however, there was no evidence for differences between
the groups in change over time. A reduction in generalized social
anxiety was observed from baseline to 6 weeks and frombaseline to 12 weeks in the alternating Re-Train Your Brain and
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JMIR FORMATIVE RESEARCH
control groups and from baseline to 12 weeks in the integrated
group. There was evidence for 1 difference between the groups
in change over time, with participants in the alternating groupreporting a larger reduction in generalized social anxiety thanthe control group from baseline to 12 weeks.
Alcohol Consumption
There was no statistical evidence for changes over time ordifferences between the groups in changes over time.
Hazardous Alcohol Use
Across all the groups, there was a sustained reduction inhazardous drinking, with the largest reductions at 12 weeks. Nochanges over time or differences between groups in changes
over time were apparent.
Alcohol Cravings and Dependence
Alcohol cravings and dependence improved from baseline to 6
weeks and from baseline to 12 weeks in both Re-Train Your
Brain groups. No changes were observed in the control group.
There was evidence for 1 difference between the groups inchange over time, with the alternating group reporting
significantly greater reductions in cravings than the control
group from baseline to 6 weeks (P=.005).

Sensitivity Analysis
Nonnormal distribution of the residuals was observed for anxiety
interpretation bias scores, alcohol approach and non–alcohol
approach bias scores, social anxiety disorder symptoms, alcohol
craving, and severity of dependence. For these variables, thebest normality transformation was identified, and analyses wereconducted using the transformed data (Multimedia Appendix
1). In all cases, there was no substantive difference in the results
using transformed data; thus, results from raw data models arereported for the ease of interpretation.

Discussion
Principal Findings
Consistent with the study hypotheses, both Re-Train Your Brain
program formats were feasible and acceptable for young adults
and resulted in greater improvements when coupled with TAU
than TAU only in some cognitive and clinical outcomes (ie,anxiety interpretation biases, comorbid social anxiety andalcohol interpretation biases, generalized social anxiety
symptoms, and alcohol cravings). Contrary to the hypotheses,
the integrated intervention was not associated with greater
engagement or clinical effects than the alternating intervention.
Only 1 difference was detected between the 2 intervention
groups, with the integrated intervention being rated as lesssimple and user-friendly than the alternating intervention.

Feasibility and Acceptability
There were strong indicators of study feasibility, having
exceeded initial recruitment targets (n=90), largely because of
the success of social media advertising for this population, as
seen in other internet-delivered trials [93]. There were also highlevels of consent (99/100, 99%) and few withdrawals (4/100,4%). Nearly three-quarters (73/100, 73%) of the sample
provided complete data for at least 1 of the follow-ups, whichhttps://formative.jmir.org/2023/1/e46008

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Prior et al
is comparable with or higher than what was seen in other webor app-based IBM or ApBM studies [37-39,41,42,94,95].
Unexpectedly, the follow-up rates at both follow-ups weresignificantly lower in the alternating intervention group than in
the control group. Given that there were no significant
differences in follow-up rates between the 2 intervention groups
and no baseline characteristics associated with attrition, it isunclear whether particular aspects of the alternating program
delivery contributed to this effect.
The data also demonstrated high levels of intervention feasibility
with regard to training adherence and attrition. Approximately
three-quarters of both the integrated intervention group (27/35,
77%) and alternating intervention group (24/32, 75%) completed
the psychoeducational module and at least 1 training session.
Moreover, 1 in 3 (25/67, 37%) completed all 10 training
sessions, and 1 in 2 (33/67, 49%) completed the optimum doseof 6 training sessions, with approximately 5 training sessions
being completed. Rates of training engagement and completion
were at the top end of adherence levels reported in similar digital
CBM research efficacy studies (eg, with 3%-43% completing
all required training sessions [38,42,43,96]) and feasibility
studies for digital IBM (eg, 47% in study 2 [97]) and ApBM inclinical settings (eg, 58% [41]). Incorporation of thepsychoeducation module, which contained motivational
enhancement and a compelling rationale at the outset of the
program, may have been particularly important for initial buy-inand setting expectations about the purpose and nature of theintervention. This may have enhanced the motivation to train
and thus may have resulted in increased adherence and lower
attrition. Future research may consider adopting a similar
approach to overcome the high rates of attrition and low
adherence reported in prior CBM research (eg, the studies byWiers et al [38] and Ji et al [43]). However, it should be notedthat the adherence rates were lower than those reported infeasibility studies of internet-delivered or app-based IBM
programs that are coupled with in-person reminders andmotivational enhancement by primary care providers (eg, 75%[98,99]). Future studies may also consider the inclusion of
face-to-face support and encouragement by health providers as
a way to optimize adherence to adjunctive CBM programs. No
serious adverse events were reported, and no adverse eventswere attributed to either Re-Train Your Brain program,suggesting that the interventions can be safely delivered as asupplement to TAU.
Overall, the participants found the program acceptable. Bothintervention groups overwhelmingly rated the intervention as
credible, user-friendly, and simple. The System Usability Scalescores were equivalent to an “A” grade [67,68], the highest
possible rating, indicating that the program is “excellent” andassociated with a positive user experience. This is a substantial
improvement from previous youth-rated usability scores for
Re-Train Your Brain (yielded before incorporating feedback
from end users and clinicians) [48], and these scores are higher
than those of other recent web-based interventions for mental
disorders [100-102]. There were also high rates of treatment
satisfaction. Scores on the Client Satisfaction Questionnaire
among both intervention groups (mean approximately 24)
indicate that the participants averaged “mostly satisfied” on
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JMIR FORMATIVE RESEARCH
each measure item, which is consistent with [97] or higher than[37] ratings provided in previous IBM and ApBM feasibility
and acceptability studies. The participants in the integrated
group reported finding the program less simple and user-friendly
than those in the alternating group, perhaps because of needing
to shift focus between the 2 vastly different training tasks withineach session. Although quantitative feedback indicated that the
program was not particularly enjoyable, motivating, or engaging,open feedback generally commended the program. Contrary toprevious literature, which suggests that trial repetition, boredom,and disengagement are serious concerns for CBM training[56,57], qualitative feedback on the aspects of the program theyfound most and least helpful indicated that the reaction
time–based nature of ApBM was “fun” and that IBM had clear
implications for real-life application of learnings. This is in linewith other recent qualitative studies of app-based ApBM
programs [103]. One way to further boost enjoyment andengagement with the program may be to personalize the content
of the training such that participants can select personally
relevant IBM social scenarios [98] and ApBM alcohol andnonalcohol images [40]. Together, these findings suggest thatboth modalities of Re-Train Your Brain are feasible to deliverin real-world settings and are worthy investments for continued
research.

Preliminary Efficacy
For interpretation biases, there were large reductions over time(at the 6-week and 12-week follow-ups) in both intervention
conditions, and large reductions relative to the control at the
6-week follow-up. As part of this, both intervention groups
exhibited large increases in positive interpretations of ambiguous
information at 6 weeks and 12 weeks, and this was accompaniedby large reductions in negative interpretations at 6 weeks,compared with the control group. These findings converge withaccumulating evidence on the efficacy of IBM in changing theinterpretive style in both adults and young people[23,25,56,104]. For comorbid social anxiety and alcoholinterpretation biases, there were a small to moderate reduction
in all 3 groups from baseline to the 6-week follow-up and alarge reduction in the intervention groups at the 12-weekfollow-up. Both the alternating and integrated groups showed
improved comorbidity interpretation biases compared with thecontrol group at the 12-week follow-up. Changes ininterpretation and comorbidity expectancy biases were expected
to be accompanied by reduced anxiety symptoms. Suchcorresponding effects were found for generalized social anxiety,whereby at the 12-week time point, the alternating Re-Train
Your Brain group demonstrated greater reduction than thecontrol group. The finding that the intervention effects weredetectable at the 12-week follow-up is particularly encouraging
in light of the brevity (totaling a maximum of 3 h of training),
low cost, and simplicity of the intervention. However, there
were no differential effects of group on social anxiety symptoms.
Future studies with greater statistical power may consider
investigating whether changes in these biases mediated changes
in clinical symptoms.
Training did not modify alcohol approach biases. The absenceof such a training effect may be due to the low reliability of theApproach Avoidance Task [72,105], which is the most widely
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Prior et alused measure for alcohol approach biases. Despite this, bothintervention groups had moderate to large reductions in theseverity of alcohol dependence and craving over the course of
the study, with the alternating Re-Train Your Brain groupexperiencing greater reductions in cravings at the 6-weekfollow-up relative to the control group. A variety of nonspecificfactors may have contributed to the observed reduction incravings, including the devaluation of alcohol, decreased
availability and exposure to alcohol due to COVID-19
restrictions, and increased motivation to change. The large,
positive reduction in cravings in the alternating group addresses
previously reported concerns regarding the safety of exposing
patients to alcohol stimuli [106,107]. It also suggests that
exposure to alcohol images in 20-minute training blocks via
ApBM may reduce the impact that visual alcohol cues have on
triggering craving (ie, desensitization), although future researchwith larger samples is required to confirm these findings.
Although there were no changes in alcohol consumption overtime in any group, all 3 groups showed moderate to large
reductions in their level of hazardous drinking across the study
period (albeit no group differences were detected). The
nondifferential finding on alcohol consumption is corroborated
by the results of previous web-based ApBM trials, in which
reduced drinking was reported across all conditions [38]. This
may signify the difficulty of achieving an improvement indrinking outcomes over and above what can be achieved by
TAU. Although this study focused on a young treatment-seeking
population who reported drinking at hazardous (or greater)levels and were motivated to change their drinking, the effects
of ApBM training are reported to be most beneficial for older
people with more severe drinking problems (ie, adults with an
alcohol use disorder) [30]. It is also suggested that there arelikely to be different treatment goals between web-based ApBM
studies with problem drinkers (ie, reduced drinking) and in-clinic
trials among patients who exhibit alcohol dependence (ie,abstinence) [20,38], which may contribute to the nonexistentor nonspecific effect on some drinking-related outcomes.
Another possible explanation for reduced drinking across the
3 conditions is that all the participants completed the 5-minute
twice-weekly check-in assessments of their anxiety and alcohol
use symptoms, and assessment reactivity (ie, from mere
exposure to alcohol questions) may have reduced alcohol use
by increasing awareness and problem recognition and motivating
behavior change [108,109]. The current sample also had lower
initial levels of drinking (average drinks) than youth with anxiety
and hazardous drinking in previous studies [93], which may
have restricted any potential benefits of training.

Strengths and Limitations
This study’s strengths include an investigation into the feasibility
and acceptability of a comorbidity-focused IBM+ApBM
program that is backed by a strong theoretical rationale. By
combining IBM and ApBM training, there was potential toenhance the effects on cognitive biases, anxiety, and alcohol
outcomes beyond what training with either type of bias
individually would provide. The program was delivered via theinternet, a preferred treatment modality for young people [49],thus offering participants desired flexibility, anonymity, andconvenience. Training was completed at home in naturalistic
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JMIR FORMATIVE RESEARCH
environments, which may enhance the transfer of training effects
to “real-world” experiences. The examination of the 2 different
formats of the program was important for furthering ourunderstanding of which generated greater engagement andimprovements in clinical outcomes, based on the observed effectsizes. Overall, both formats were equally feasible to deliver andaccepted by young people, with the exception of the simplicity
of use, which was rated lower in the integrated group. The
follow-up rates were also lower in the alternating group than in
the control group. With regard to efficacy, the alternating group
showed larger effect sizes over time than the integrated groupand had greater impacts on cognitive and clinical outcomes thanthe control group. The alternating delivery model may be apreferred option for future comorbid anxiety-alcohol CBM
research, albeit efforts should be made to improve follow-up
rates in this model. Alternatively, the format of delivery might
be decided based on an individual user’s preference for an
integrated or alternating format, rather than assuming a
one-size-fits-all approach to selecting the optimal delivery
format. Future research may benefit from developing simple
protocols for establishing within-person preferences regarding
the 2 delivery formats. The study also had relatively low
treatment and study attrition.
The trial also had several limitations, primarily its small pilot
trial sample size and use of a relatively homogeneous,nondiagnosed sample. Although the study had an appropriate
size for examining feasibility and acceptability, it did not haveadequate power to properly test its efficacy in improving
cognitive biases or clinical symptoms, which may have biased
the estimated effect sizes. The study also included multiple
secondary outcome measures for efficacy without an adjustmentof the P value, which increases the risk of type 1errors (ie,findings of false “significance”). However, because of the pilot
nature of the study, which is not powered for efficacy analyses,
the results focus on the magnitude of effect rather than on
statistical significance. Another limitation is that given thatTAU alone can have powerful clinical effects (particularly whentreatment is standardized), a substantially larger sample could
be required to detect benefits beyond those conferred by TAU.
Future trials with a larger sample size could examine this further
and determine whether a change in biases mediates changes inclinical symptoms as well as whether the effects are moderated
by age, sex, and TAU type and stage. Another limitation wasthat the control condition was not matched to the Re-Train Your
Brain program. The selection of a suitable or optimal control
condition is a commonly reported challenge in past CBM
research, especially given that sham training (a “neutral” control
condition) may actually function as an “active” condition rather
than the neutral condition it is intended to be [110]. The
Re-Train Your Brain interventions are targeted at individuals
with co-occurring social anxiety and hazardous alcohol use, yet
few participants in this trial reported social anxiety as theirprimary concern. Although this has the potential to influence

Prior et al
the generalizability of the findings, two-thirds to three-quartersof the participants across the conditions met the criteria forpossible social anxiety disorder; therefore, generalizability
should be relatively unaffected.
A further limitation of this study was that although hazardous
use in the past year was an eligibility criterion, 1 in 3 participants
had not consumed alcohol in the past month at baseline. This
was largely observed among the participants in the integrated
intervention group (a chance finding, where over half of thegroup had not consumed any alcohol in the month before
baseline). It is unclear whether this low level of use may havebeen a by-product of the sample receiving psychologicaltreatment or whether there were potential impacts of COVID-19
social isolation rules and restrictions. Future studies could
consider incorporating an eligibility criterion that ensures thatparticipants are current hazardous drinkers or, if statistical power
allows, run subgroup analyses among current drinkers to better
understand the intervention effects among the intended target
population of current hazardous drinkers.
In addition, specific feasibility benchmarks were unfortunately
not prespecified, and the study was unable to investigate theefficacy of the intervention as a function of the type of TAU
the participants were receiving. TAU is typically standardized
across groups in CBM research (eg, ApBM plus residential
inpatient alcohol treatment) [29-33] to prevent variability in theintensiveness and effectiveness of TAU and any potential
masking of CBM intervention effects. Although this study did
not standardize TAU, we would argue that this approach is still
ecologically valid in terms of evaluating whether it would add
to routine care. It was also assumed that any heterogeneous
external treatment effects would be minimized in this study
because of randomization to conditions. Future research witha larger sample may consider examining whether Re-Train Your
Brain’s efficacy is greater when used as a supplement toparticular types of treatment.

Conclusions
For the first time, this study demonstrated the feasibility andacceptability of delivering a comorbidity-focused, web-based
IBM plus ApBM program as an adjunct treatment for youth
with co-occurring social anxiety and hazardous drinking. Bothformats of the Re-Train Your Brain intervention were associatedwith improvements in cognitive biases, and the alternatingintervention had additional benefits on some anxiety- anddrinking-related outcomes relative to the control, although otherclinical outcomes suggested comparable changes for the TAU
control condition. Internet-delivered IBM+ApBM training
offered through a publicly available website may represent a
scalable, low-cost, and non–labor-intensive intervention fortargeting interpretation, alcohol approach, and comorbidity
biases as well as anxiety symptom severity and alcohol-related
outcomes in the real world. Further research (eg, fully powered
RCTs) into this adjunct treatment approach is clearly warranted.

Acknowledgments
This research was possible because of salary support from Australian Rotary Health (2019-2023) and research support (seedfunding grants) provided by the National Health and Medical Research Council Centre of Research Excellence in the Prevention

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and Early Intervention in Mental Illness and Substance Use (PREMISE; GNT11349009) and the University of Sydney (theLifespan Research Network, the Brain and Mind Centre, and the Office of Global Engagement [eg, Utrecht-USyd Partnership
Collaboration Grant]). Australian Rotary Health, PREMISE, and the University of Sydney did not influence the design or executionof this study or its analyses, interpretation, or decision to submit the results. The authors would also like to thank the Netfront
Digital Agency for setting up the study website and contributing to the development of the intervention. Finally, the authors are
extremely grateful to the study participants.

Authors' Contributions
KP, LAS, ES, and RWW designed the study and obtained funding support. KP and MP recruited and followed up participants.
KP prepared the first draft of the manuscript. All the authors assisted with the methodological aspects of the trial and reviewed
and contributed to the final manuscript.

Conflicts of Interest
The authors are developers of the Re-Train Your Brain program.

Multimedia Appendix 1
Supplementary materials containing full description of study measures and the sensitivity analyses.
[DOCX File , 39 KB-Multimedia Appendix 1]

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Abbreviations
ApBM: approach bias modification
AUDIT: Alcohol Use Disorder Identification Test
CBM: cognitive bias modification
CONSORT: Consolidated Standards of Reporting Trials
IBM: interpretation bias modification
OR: odds ratio
RCT: randomized controlled trial
SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials
TAU: treatment as usual

Edited by A Mavragani; submitted 25.01.23; peer-reviewed by M Rinck, C Beard; comments to author 20.03.23; revised version
received 24.04.23; accepted 09.06.23; published 25.10.23
Please cite as:
Prior K, Salemink E, Piggott M, Manning V, Wiers RW, Teachman BA, Teesson M, Baillie AJ, Mahoney A, McLellan L, Newton NC,
Stapinski LA
Web-Based Cognitive Bias Modification Program for Young People With Social Anxiety and Hazardous Alcohol Use: Feasibility,
Acceptability, and Preliminary Efficacy StudyJMIR Form Res 2023;7:e46008
URL: https://formative.jmir.org/2023/1/e46008
doi: 10.2196/46008
PMID:©Katrina Prior, Elske Salemink, Monique Piggott, Victoria Manning, Reinout W Wiers, Bethany A Teachman, Maree Teesson,
Andrew J Baillie, Alison Mahoney, Lauren McLellan, Nicola C Newton, Lexine A Stapinski. Originally published in JMIR
Formative Research (https://formative.jmir.org), 25.10.2023. This is an open-access article distributed under the terms of theCreative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution,and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The
complete bibliographic information, a link to the original publication on https://formative.jmir.org, as well as this copyright andlicense information must be included.

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