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Alcohol use and anxiety disorders commonly co-occur, resulting in a more severe clinical presentation and poorer response to treatment. Research has shown that approach bias modification (ApBM) and interpretation bias modification (IBM) cognitive retraining interventions can be efficacious adjunctive treatments that improve outcomes for alcohol use and social anxiety, respectively. However, the acceptability, feasibility, and clinical utility of combining ApBM and IBM programs to optimize treatments among comorbid samples are unknown. It is also unclear whether integrating ApBM and IBM
This paper describes the protocol for a randomized controlled pilot trial investigating the feasibility, acceptability, and preliminary efficacy of the
The study involves a three-arm randomized controlled pilot trial in which treatment-seeking emerging adults (18-30 years) with co-occurring hazardous alcohol use and social anxiety will be individually randomized to receive the
This study is funded from 2019 to 2023 by Australian Rotary Health. Recruitment is expected to be completed by mid-2022 to late 2022, with follow-ups completed by early 2023.
This study will be the first to evaluate whether an ApBM+IBM program is acceptable to treatment-seeking, emerging adults and whether it can be feasibly delivered via the web, in settings where it will ultimately be used (eg, at home). The findings will broaden our understanding of the types of programs that emerging adults will engage with and whether the program may be an efficacious treatment option for this comorbidity.
Australian New Zealand Clinical Trials Registry ACTRN12620001273976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364131
PRR1-10.2196/28667
Social anxiety and alcohol use disorders are highly prevalent [
Given the frequent co-occurrence of these disorders and the additional complications that this comorbidity confers on the individual (eg, physical and psychological health, relationships, work, and education) and society (eg, social and economic costs) [
Over the past two decades, several computer-based cognitive training paradigms, known as cognitive bias modification (CBM), have been developed to reduce symptoms by modifying a range of maladaptive implicit biases, including alcohol approach and anxiety-related interpretation biases.
Several large RCTs [
Clinical studies investigating the efficacy of IBM have shown that training can promote the development of a positive interpretive bias in socially anxious populations and that these modifications are associated with reductions in social anxiety symptoms [
A limitation to the clinical utility of ApBM and IBM interventions to date is that they have predominantly been restricted to the confines of a laboratory or clinic [
Overall, although the evidence base for the efficacy of laboratory- and web-based ApBM and IBM is accumulating for adults with singular disorders, their efficacy when delivered to people with co-occurring social anxiety and alcohol use problems remains largely unknown. To the authors’ knowledge, only one RCT exists that examines the efficacy of an attention bias–focused CBM program among a socially anxious, alcohol-dependent adult sample (N=86) [
Addressing these gaps in the literature, the research team codeveloped a hybrid, web-based ApBM+IBM for emerging adults with co-occurring hazardous alcohol use and social anxiety (
This paper describes the study protocol for a randomized controlled pilot trial investigating the feasibility, acceptability, and preliminary efficacy of the
It is hypothesized that the integrated and alternating
The study will be conducted nationally across Australia and will involve a three-arm randomized controlled pilot trial in which eligible participants will be individually randomized to receive (1) the
Study design for the
The
Young Australians (n=90) aged 18 to 30 years with harmful alcohol use and heightened social anxiety symptoms who are currently receiving psychological treatment will be recruited into the study via an array of advertising methods, including clinician referral, poster, and flyer advertisements (eg, in clinical services and universities), and online advertising via platforms, such as Facebook, Twitter, and Google AdWords.
To be eligible, participants must (1) be Australians aged 18-30 years; (2) be currently reporting hazardous or harmful alcohol use, that is, a score of ≥8 on the Alcohol Use Disorder Identification Test [
Individuals will be excluded because of the following reasons: inability or unwillingness to provide contact information (ie, phone and email); insufficient English literacy; active symptoms of psychosis, that is, a score of ≥3 on the Psychosis Screening Questionnaire [
Schedule of assessments and procedures over the study period.
Assessments | Study period | ||||||||||||||||||||
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Enrollment | Preallocation; |
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Informed consent | ✓a |
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Eligibility survey | ✓ |
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Baseline survey |
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✓ |
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Cognitive assessments |
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✓ |
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✓ | ✓ | |||||||||||
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Randomization |
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✓ |
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Group 1: Integrated ApBMb+IBMc plus TAUd |
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✓ | ✓ | ✓ | ✓ | ✓ |
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Group 2: Alternating ApBM+IBM plus TAU |
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✓ | ✓ | ✓ | ✓ | ✓ |
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Group 3: TAU (routine anxiety or alcohol treatment) |
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✓ | ✓ | ✓ | ✓ | ✓ |
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Treatment feasibility questions |
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✓ |
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Acceptability questions |
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✓ |
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System Usability Scale |
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✓ |
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Client Satisfaction Questionnaire |
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✓ |
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Treatment feedback questions |
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✓ |
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Postuser experience questions (intervention groups) |
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✓ | ✓ | ✓ | ✓ | ✓ |
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Approach Avoidance Task |
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✓ |
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✓ | ✓ | ||||||||||
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Interpretation Recognition Task |
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✓ |
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✓ | ✓ | ||||||||||
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Comorbid Interpretation and Expectancy Biases |
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✓ |
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✓ | ✓ | ||||||||||
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Social Phobia Scale and Social Interaction Anxiety Scale-Short Forms | ✓ |
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✓ | ✓ | ||||||||||
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Patient Health Questionnaire-4 |
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✓ |
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✓ | ✓ | ||||||||||
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Alcohol Use Disorder Identification Test | ✓ |
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✓ | ✓ | ||||||||||
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Timeline Follow Back |
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✓ |
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✓ | ✓ | ||||||||||
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Alcohol Craving Questionnaire–Short Form–Revised |
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✓ |
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✓ | ✓ | ||||||||||
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Severity of Alcohol Dependence Questionnaire |
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✓ |
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✓ | ✓ | ||||||||||
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Drinking Motives Questionnaire-Revised |
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✓ |
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✓ | ✓ | ||||||||||
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Weekly Social Anxiety and Alcohol Symptom questions |
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✓ | ✓ | ✓ | ✓ | ✓ |
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Readiness to Change Ruler |
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✓ |
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✓ | ✓ | ||||||||||
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University of Rhode Island Change Assessment |
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✓ |
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Psychological and pharmacological treatment |
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✓ |
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✓ | ✓ |
aDenotes which assessments and/or measures were conducted at each time point.
bApBM: approach bias modification.
cIBM: interpretation bias modification.
dTAU: treatment as usual.
The feasibility of the program will be assessed according to the percentage of successfully recruited participants who agree to participate (ie, uptake), commence training, and decline participation. At postintervention, feasibility will be measured by the number of sessions completed; reporting of adverse events via spontaneous reports in open-feedback questions or to the study team or deterioration of social anxiety or alcohol use symptoms (see
Measures of acceptability and usability of the program will be assessed at postintervention (6-week postbaseline).
The following measures will be assessed at baseline, postintervention, and 3 months postbaseline (a more detailed description and interpretation of scores are given in
(Title):
(Scenario): You’ve just started going to an evening class. The instructor asks a question and no one in the group volunteers an answer, so he looks directly at you. You answer the question, aware of how your voice must sound to the...
(Word fragment): oth-rs
(Correct word): others
(Comprehension question): Have you been going to the evening class for a long time?
(Response): No
(Feedback): ✓ Correct answer
In the recognition test phase, participants are presented with the identifying titles of each ambiguous scenario, together with four interpretations of each of the scenarios, presented one at a time. Participants are asked to rate each summary statement independently for their similarity in meaning to the original scenario on a 4-point Likert scale from 1 (
Positive target: You answer the question, aware of others listening attentively.
Negative target: You answer the question, aware of how unsteady your voice sounds.
Positive foil: You answer the question and then realize what a good answer it is.
Negative foil: You answer the question but realize that you have made a mistake.
Both the integrated and alternating Re-
ApBM is a modified training version of the assessment Alcohol Approach Task, in which participants pull or push a computer mouse in response to the orientation of images (containing alcoholic or nonalcoholic beverages), which zooms the image in or out (
Example of Approach Bias Modification scenario to illustrate the training procedures.
In IBM training, participants are trained to resolve ambiguous social scenarios with either positive or benign outcomes through the completion of a word fragment (
Example of Interpretation Bias Modification scenario to illustrate the training.
Group 1 will receive 10 biweekly training sessions containing shortened versions of
Participants in group 2 will receive the same treatment dose as group 1; however, on alternating weeks, participants will receive either ApBM
The control group will receive TAU, which will be the model of care provided in accordance with standard practices at their service. The focus of the psychological treatment will not be limited to the provision of treatment for anxiety and/or alcohol use (ie, clients may be receiving treatment for other conditions in addition to anxiety and/or alcohol use). No restrictions will be placed on the type of psychological treatment or how long the client has been receiving the treatment. Details regarding the type, length, and focus of treatment will be ascertained during the baseline and follow-up surveys and reported upon in the trial outcomes (more information given in
All participants will be directed to the
All participants will be emailed a link to complete an online survey and a (separate) cognitive assessment at postintervention (ie, 6 weeks postbaseline, to provide 1 week of flexibility in the rate of training completion) and 3 months postbaseline. The survey and cognitive assessments are expected to take approximately 45-60 minutes (combined) to complete at each time point. Consistent with previous online trials [
To avoid bias, participants will be individually randomized to the
As this is a pilot trial, a formal power calculation is not required [
Descriptive statistics for primary and secondary outcomes will be conducted based on frequencies and cross-tabulations. Analyses for secondary (preliminary) efficacy outcomes will use multilevel mixed effects analysis for repeated measures, which is a flexible analytic approach for modeling change over time using RCT data [
Recruitment is expected to be completed by mid-2022 to late 2022, with the 6-week and 3-month follow-ups to be completed by early 2023. The results are expected to be submitted for publication in 2023. The research team intends to present the findings of this trial at professional seminars and national and international conferences. Only aggregated group data will be reported, and no individuals will be identified.
This paper presents the design of the
This study has several strengths. First, the intervention was co-designed with emerging adults who have direct lived experience of hazardous drinking and social anxiety and clinicians who have experience treating anxiety and/or alcohol use concerns. This bottom-up approach, whereby emerging adults and clinicians were involved in the development of the methodology and stimuli used within the intervention (eg, the alcoholic or nonalcoholic beverages used in ApBM and the scenarios included in IBM), was critical to ensuring that the program is relevant, engaging, and useful for end users. This codevelopment process also helps to ensure that the program can be feasibly implemented and is responsive to the needs of service providers.
An additional strength of this study is the web-based delivery of the interventions. The
Finally, despite their high co-occurrence, to date, most CBM programs have addressed anxiety and alcohol use in isolation of one another, with a few exceptions for attention bas modification [
One of the main strengths of this study is also its main limitation: that is, its web-based delivery. First, internet interventions are conducted in a less-controlled home environment that may pose several online distractions (eg, email notifications) and offline distractions (eg, housemates or phone calls), which have the potential to impact the study results. Second, web-based interventions also have higher rates of attrition compared with standard face-to-face treatments (eg, 34.2% vs 24.6%, respectively) [
Furthermore, this study uses a control group that receives TAU and zero training, rather than a control group that is matched for both stimulus exposure (ie, time spent completing the ApBM and IBM tasks) and response requirements. Sham control-training groups are considered the optimal comparator groups for these reasons and because participants remain blind to their group allocation [
This world’s first hybrid ApBM+IBM training program combines the best elements of efficacious ApBM training programs for alcohol use problems and IBM for social anxiety into a hybrid program for emerging adults who experience both of these problems. This innovative program can be delivered over the internet and can thereby maximize efficiency and scarce resources and sustainably increase the intervention options for vulnerable populations at a low cost. Given the costs of conducting an RCT, it is important to establish whether the
A detailed description and interpretation of scores for primary and secondary outcome measures.
approach bias modification
cognitive bias modification
Consolidated Standards of Reporting Trials
interpretation bias modification
randomized controlled trial
Standard Protocol Items: Recommendations for Interventional Trials
treatment as usual
This work was supported by Australian Rotary Health (salary support for KP from 2019-2023), as well as research support provided by an early career researcher seed funding grant from the National Health and Medical Research Council Centre of Research Excellence in the Prevention and Early Intervention in Mental Illness and Substance Use, two seed funding grants from the University of Sydney’s Lifespan Research Network, and a University of Sydney-Utrecht University Partnership Collaboration Award. Australian Rotary Health, the Centre of Research Excellence in the Prevention and Early Intervention in Mental Illness and Substance Use, the University of Sydney, and Utrecht University did not influence the design of the study or the writing of the manuscript. The authors would like to thank Samuel Campbell from Turning Point for creating an initial version of the intervention and Netfront Digital Agency for setting up the study website and finalizing the development of the intervention.
KP, ES, RWW, and LAS designed the study and obtained the funding support. KP and MP prepared the first draft of the manuscript. ES and VM shared study documents and materials related to ApBM and IBM. All authors assisted with the methodological aspects of the trial and reviewed and contributed to the final manuscript.
The authors are the developers of the