Dataset Information

A Web-Based Cognitive Bias Modification Intervention (Re-train Your Brain) for Emerging Adults With Co-occurring Social Anxiety and Hazardous Alcohol Use: Protocol for a Multiarm Randomized Controlled Pilot Trial.

ABSTRACT:

Background

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 within each training session or alternating them between each session is more acceptable and efficacious.

Objective

This paper describes the protocol for a randomized controlled pilot trial investigating the feasibility, acceptability, and preliminary efficacy of the Re-train Your Brain intervention-an adjunct web-based ApBM+IBM program-among a clinical sample of emerging adults with hazardous alcohol use and social anxiety.

Methods

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 Re-train Your Brain integrated program, delivered with 10 biweekly sessions focusing on both social anxiety and alcohol each week, plus treatment as usual (TAU; ie, the model of care provided in accordance with standard practice at their service; n=30); the Re-train Your Brain alternating program, delivered with 10 biweekly sessions focusing on social anxiety one week and alcohol the next week, plus TAU (n=30); or TAU only (n=30). Primary outcomes include feasibility (uptake, follow-up rates, treatment adherence, attrition, and adverse events) and acceptability (system usability, client satisfaction, user experience, and training format preference). Secondary efficacy outcomes include changes in alcohol approach and interpretation biases, social anxiety, and alcohol use (eg, drinks per day, binge drinking, drinking motives, severity of dependence, and cravings). The primary end point will be posttreatment (6 weeks postbaseline), with a secondary end point at 3 months postbaseline. Descriptive statistics will be conducted for primary outcomes, whereas intention-to-treat, multilevel mixed effects analysis for repeated measures will be performed for secondary outcomes.

Results

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.

Conclusions

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.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12620001273976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364131.

International registered report identifier (irrid)

PRR1-10.2196/28667.

SUBMITTER: Prior K

PROVIDER: S-EPMC8295835 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BACKGROUND:Cognitive biases refer to automatic attentional or interpretational tendencies, which result in individuals with addictive disorders to automatically attend to substance-related stimuli and those with anxiety disorders to attend to threatening stimuli. To date, several studies have examined the efficacy of cognitive bias modification, and meta-analytical studies have synthesized the evidence for overall efficacy. The clinical utility of cognitive bias modification interventions has previously been limited to the confines of a laboratory, but recent advances in Web technologies can change this. OBJECTIVE:This scoping review aimed to determine the scope of Web-based cognitive bias interventions and highlight their effectiveness. METHODS:Databases (PubMed and MEDLINE, EMBASE, PsycINFO, ScienceDirect, and Cochrane Central) were searched from inception to December 5, 2017. The following search terminologies were used: ("attention bias" OR "cognitive bias" OR "approach bias" OR "avoidance bias" OR "interpretative bias") AND ("Internet" OR "Web" OR "Online"). The methods for this scoping review are based on the previously published protocol. For the synthesis of the evidence, a narrative synthesis was undertaken, as a meta-analysis was not appropriate, given the lack of reported effect sizes and the heterogeneity in the outcomes reported. RESULTS:Of the 2674 unique articles identified, we identified 22 randomized controlled studies that met our inclusion criteria: alcohol use disorder (n=2), tobacco use disorder (n=2), depressive disorder (n=3), anxiety and depressive symptoms in adolescents (n=3), obsessive-compulsive disorder (OCD; n=2), social anxiety disorder (n=9), and anxiety disorder (n=1). The sample sizes of these studies ranged from 16 to 434 participants. There is preliminary evidence to suggest that Web-based interventions could reduce biases among adolescents with heightened symptoms of anxiety and depression and among individuals with OCD. CONCLUSIONS:This is the first scoping review that mapped out the scope of cognitive bias modification interventions for psychiatric disorders. Web-based interventions have been applied predominantly for social anxiety and addictive disorders. Larger cohorts must be used in future studies to better determine the effectiveness of Web-based cognitive bias interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/10427.

Project description:BackgroundCognitive bias modification (CBM), a set of techniques for modifying bias in information processing-is considered a novel intervention for social anxiety disorder (SAD), which has drawn considerable interest from researchers. However, the effects of CBM on SAD are not consistent. Some studies have demonstrated significant positive effects compared to control groups, while others have found no such effects.AimsWe conducted a meta-analysis aimed at quantitatively assessing the effects of CBM on SAD at post-test.MethodThrough a systematic literature search by two independent raters, 34 articles (36 randomized studies) including 2,550 participants were identified. A multilevel modeling approach was employed to assess the effects of CBM on SAD, and to explore the potentially crucial procedures and sample characteristics that enhance the effectiveness of benign training.ResultsIn general, there were small but significant effects of CBM on the primary symptoms of SAD (g = 0.17), cognitive bias (CB) toward threat (g = 0.32), and reactivity in stressful situations (g = 0.25), but non-significant effects on secondary symptoms. However, the interpretation modification program was more effective than was attentional bias modification in reducing SAD primary symptoms and negative CB. Laboratory training procedures produced larger primary symptom reductions compared to Internet-based training, whereas the percentage of contingency and feedback about training performance boosted cognitive effects only. Finally, the following groups were more likely to benefit from CBM: younger participants (primary symptoms and cognitive effects), women (primary symptom effects), and samples with stronger CB (stressor effects). The quality of the randomized controlled trials was less than desirable, as there was some indication of publication bias in our study.ConclusionsCurrent findings broadly supported cognitive theories of SAD that consider a bidirectional or mutually reinforcing relationship between symptoms and CBs. However, the small therapeutic effect observed here indicates that it is necessary to develop more reliable and efficient CBM interventions that are specific to SAD.

Project description:BackgroundAnxiety and alcohol use disorders are common and disabling conditions that people typically endure for many years before accessing treatment. The link between anxiety and alcohol use is well-established, with these issues commonly emerging and/or escalating during emerging adulthood. This randomized controlled trial evaluated a psychologist-supported, web-based intervention, designed with and for emerging adults, that aims to promote adaptive coping strategies, and prevent anxiety and alcohol use from progressing to chronic, mutually-reinforcing disorders.MethodsBetween December 2017 and September 2018, 123 emerging adults (aged 17-24) reporting anxiety symptoms and hazardous alcohol use were randomized to receive the Inroads or control (assessment plus alcohol information) intervention. The Inroads program combined five web-based cognitive behavioral therapy modules with weekly psychologist support via email/phone. Primary outcomes were alcohol consumption, severity of alcohol-related consequences, and general anxiety symptoms, assessed at baseline, 2 and 6-months post-baseline. Secondary outcomes included hazardous alcohol use and social anxiety. Trial Registration: Prospectively registered in the Australian New Zealand Clinical Trials Registry, ACTRN12617001609347.FindingsAlcohol consumption and associated consequences reduced in both groups, with the Inroads group reporting greater alcohol reductions by 6-month follow-up (mean difference -0.74, 95% CI: -1.47 to -0.01, d = 0.24). Relative to controls, hazardous alcohol use reduced among Inroads participants at both follow-ups (2-month mean difference -2.14, 95% CI: -4.06 to -0.22). Inroads participants also reported reduced symptoms of general (mean difference -3.06, 95% CI: -4.97 to -1.15, d = 0.88) and social anxiety (mean difference -3.21, 95% CI: -6.34 to -0.07, d = 0.32) at 2-month follow-up, with improvements in social anxiety sustained at 6-months.InterpretationThe Inroads program demonstrated beneficial effects on alcohol consumption, hazardous alcohol use, and anxiety symptoms. The web-based format is aligned with youth treatment preferences and can be delivered at scale to achieve wide dissemination and reduce the significant burden associated with these chronic, mutually reinforcing conditions.FundingAustralian Rotary Health, Australian National Health and Medical Research Council.

Project description:BACKGROUND:Automatically activated cognitive motivational processes such as the tendency to attend to or approach smoking-related stimuli (ie, attentional and approach bias) have been related to smoking behaviors. Therefore, these cognitive biases are thought to play a role in maintaining smoking behaviors. Cognitive biases can be modified with cognitive bias modification (CBM), which holds promise as an easy-access and low-cost online intervention. However, little is known about the effectiveness of online interventions combining two varieties of CBM. Targeting multiple cognitive biases may improve treatment outcomes because these biases have been shown to be relatively independent. OBJECTIVE:This study aimed to test the individual and combined effects of two web-based CBM varieties-attentional bias modification (AtBM) and approach bias modification (ApBM)-in a double-blind randomized controlled trial (RCT) with a 2 (AtBM: active versus sham) × 2 (ApBM: active versus sham) factorial design. METHODS:A total of 504 adult smokers seeking online help to quit smoking were randomly assigned to 1 of 4 experimental conditions to receive 11 fully automated CBM training sessions. To increase participants' intrinsic motivation to change their smoking behaviors, all participants first received brief, automated, tailored feedback. The primary outcome was point prevalence abstinence during the study period. Secondary outcomes included daily cigarette use and attentional and approach bias. All outcomes were repeatedly self-assessed online from baseline to the 3-month follow-up. For the examination of training effects on outcome changes, an intention-to-treat analysis with a multilevel modeling (MLM) approach was adopted. RESULTS:Only 10.7% (54/504) of the participants completed all 11 training sessions, and 8.3% (42/504) of the participants reached the 3-month follow-up assessment. MLM showed that over time, neither AtBM or ApBM nor a combination of both differed from their respective sham training in point prevalence abstinence rates (P=.17, P=.56, and P=.14, respectively), and in changes in daily cigarette use (P=.26, P=.08, and P=.13, respectively), attentional bias (P=.07, P=.81, and P=.15, respectively), and approach bias (P=.57, P=.22, and P=.40, respectively), while daily cigarette use decreased over time across conditions for all participants (P<.001). CONCLUSIONS:This RCT provides no support for the effectiveness of combining AtBM and ApBM in a self-help web-based smoking cessation intervention. However, this study had a very high dropout rate and a very low frequency of training usage, indicating an overall low acceptability of the intervention, which precludes any definite conclusion on its efficacy. We discuss how this study can inform future designs and settings of online CBM interventions. TRIAL REGISTRATION:Netherlands Trial Register NTR4678; https://www.trialregister.nl/trial/4678.

Project description:ObjectiveIn the treatment of anxiety disorders, attention bias modification therapy (ABMT) and cognitive-behavioral therapy (CBT) may have complementary effects by targeting different aspects of perturbed threat responses and behaviors. ABMT may target rapid, implicit threat reactions, whereas CBT may target slowly deployed threat responses. The authors used amygdala-based connectivity during a threat-attention task and a randomized controlled trial design to evaluate potential complementary features of these treatments in pediatric anxiety disorders.MethodPrior to treatment, youths (8-17 years old) with anxiety disorders (N=54), as well as healthy comparison youths (N=51), performed a threat-attention task during functional MRI acquisition. Task-related amygdala-based functional connectivity was assessed. Patients with and without imaging data (N=85) were then randomly assigned to receive CBT paired with either active or placebo ABMT. Clinical response was evaluated, and pretreatment amygdala-based connectivity profiles were compared among patients with varying levels of clinical response.ResultsCompared with the CBT plus placebo ABMT group, the CBT plus active ABMT group exhibited less severe anxiety after treatment. The patient and healthy comparison groups differed in amygdala-insula connectivity during the threat-attention task. Patients whose connectivity profiles were most different from those of the healthy comparison group exhibited the poorest response to treatment, particularly those who received CBT plus placebo ABMT.ConclusionsThe study provides evidence of enhanced clinical effects for patients receiving active ABMT. Moreover, ABMT appears to be most effective for patients with abnormal amygdala-insula connectivity. ABMT may target specific threat processes associated with dysfunctional amygdala-insula connectivity that are not targeted by CBT alone. This may explain the observation of enhanced clinical response to CBT plus active ABMT.