Dataset Information

Cognitive bias modification for social anxiety in adults who stutter: a feasibility study of a randomised controlled trial.

ABSTRACT:

Objective

To determine the feasibility and acceptability of a computerised treatment for social anxiety disorder for adults who stutter including identification of recruitment, retention and completion rates, large cost drivers and selection of most appropriate outcome measure(s) to inform the design of a future definitive trial.

Design

Two-group parallel design (treatment vs placebo), double-blinded feasibility study.

Participants

31 adults who stutter.

Intervention

Attention training via an online probe detection task in which the stimuli were images of faces displaying neutral and disgusted expressions.

Main outcome measures

Psychological measures: Structured Clinical Interview Global Assessment of Functioning score; Liebowitz Social Anxiety Scale; Social Phobia and Anxiety Inventory; State-Trait Anxiety Inventory; Unhelpful Thoughts and Beliefs about Stuttering. Speech fluency: percent syllables stuttered. Economic evaluation: resource use questionnaire; EuroQol three-dimension questionnaire.Acceptability: Likert Scale questionnaire of experience of trial, acceptability of the intervention and randomisation procedure.

Results

Feasibility of recruitment strategy was demonstrated. Participant feedback indicated that the intervention and definitive trial, including randomisation, would be acceptable to adults who stutter. Of the 31 participants who were randomised, 25 provided data at all three data collection points.

Conclusions

The feasibility study informed components of the intervention. Modifications to the design are needed before a definitive trial can be undertaken.

Trial registration number

I SRCTN55065978; Post-results.

SUBMITTER: McAllister J

PROVIDER: S-EPMC5665216 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Cognitive bias modification for social anxiety in adults who stutter: a feasibility study of a randomised controlled trial.

McAllister Jan J Gascoine Sally S Carroll Amy A Humby Kate K Kingston Mary M Shepstone Lee L Risebro Helen H Mackintosh Bundy B Thompson Tammy Davidson TD Hodgekins Jo J

BMJ open 20171022 10

<h4>Objective</h4>To determine the feasibility and acceptability of a computerised treatment for social anxiety disorder for adults who stutter including identification of recruitment, retention and completion rates, large cost drivers and selection of most appropriate outcome measure(s) to inform the design of a future definitive trial.<h4>Design</h4>Two-group parallel design (treatment vs placebo), double-blinded feasibility study.<h4>Participants</h4>31 adults who stutter.<h4>Intervention</h4 ...[more]

PMID: 29061602

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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:UnlabelledBiases in attention processes are thought to play a crucial role in the aetiology and maintenance of Social Anxiety Disorder (SAD). The goal of the present study was to examine the efficacy of a programme intended to train attention towards positive cues and a programme intended to train attention towards negative cues. In a randomised, controlled, double-blind design, the impact of these two training conditions on both selective attention and social anxiety were compared to that of a control training condition. A modified dot probe task was used, and delivered via the internet. A total of 129 individuals, diagnosed with SAD, were randomly assigned to one of these three conditions and took part in a 14-day programme with daily training/control sessions. Participants in all three groups did not on average display an attentional bias prior to the training. Critically, results on change in attention bias implied that significantly differential change in selective attention to threat was not detected in the three conditions. However, symptoms of social anxiety reduced significantly from pre- to follow-up-assessment in all three conditions (dwithin ?=?0.63-1.24), with the procedure intended to train attention towards threat cues producing, relative to the control condition, a significantly greater reduction of social fears. There were no significant differences in social anxiety outcome between the training condition intended to induce attentional bias towards positive cues and the control condition. To our knowledge, this is the first RCT where a condition intended to induce attention bias to negative cues yielded greater emotional benefits than a control condition. Intriguingly, changes in symptoms are unlikely to be by the mechanism of change in attention processes since there was no change detected in bias per se. Implications of this finding for future research on attention bias modification in social anxiety are discussed.Trial registrationClinicalTrials.gov NCT01463137.

Project description:BackgroundPersecutory delusions are the most common type of delusions in psychosis and present in around 10-15% of the general population. Persecutory delusions are thought to be sustained by biased cognitive and emotional processes. Recent advances favour targeted interventions, focussing on specific symptoms or mechanisms. Our aim is to test the clinical feasibility of a novel psychological intervention, which manipulates biased interpretations toward more adaptive processing, in order to reduce paranoia in patients.MethodsThe 'Cognitive Bias Modification for paranoia' (CBM-pa) study is a feasibility, double-blind, randomised controlled trial (RCT) for 60 stabilised outpatients with persistent, distressing paranoid symptoms. Patients will be randomised at a 50:50 ratio, to computerised CBM-pa or a text-reading control intervention, receiving one 40-min session per week, for 6 weeks. CBM-pa involves participants reading stories on a computer screen, completing missing words and answering questions about each story in a way that encourages more helpful beliefs about themselves and others. Treatment as Usual will continue for patients in both groups. Patients will be assessed by a researcher blind to allocation, at baseline, each interim session, post treatment and 1- and 3-month follow-up post treatment. The primary outcome is the feasibility parameters (trial design, recruitment rate and acceptability) of the intervention. The secondary outcomes are clinical symptoms (including severity of paranoia) as assessed by a clinical psychologist, and 'on-line' measurement of interpretation bias and stress/distress. The trial is funded by the NHS National Institute for Health Research.DiscussionThis pilot study will test whether CBM-pa has the potential to be a cost-effective, accessible and flexible treatment. If the trial proves feasible and demonstrates preliminary evidence of efficacy, a fully powered RCT will be warranted.Trial registrationCurrent Controlled Trials ISRCTN: 90749868 . Retrospectively registered on 12 May 2016.

Project description:BackgroundAlcohol 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.ObjectiveThis 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.MethodsThe 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.ResultsThis 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.ConclusionsThis 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 registrationAustralian 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.

Project description:BackgroundAdolescent social anxiety disorder (SAD) is common, impairing and persistent. There is a need to intervene early to avert its long-term consequences. Cognitive Therapy for SAD is the leading treatment for adults and shows promise for adolescents. However, given the scale of the problem of adolescent SAD and the limited availability of psychological therapists in child and adolescent mental health services, there is a substantial gap in service provision. Delivering therapy via the Internet may provide part of the solution to this problem. An Internet version of adult Cognitive Therapy for SAD has been developed, with outcomes similar to face-to-face therapy. We have recently adapted this treatment for use with adolescents with SAD. Here, we describe a randomised controlled trial designed to test the efficacy of Internet Cognitive Therapy for adolescent SAD compared to waitlist.Methods/designForty adolescents aged 14-18?years with a diagnosis of SAD will be recruited via schools. Participants will be randomly allocated to Internet Cognitive Therapy or to waitlist. All participants will be assessed three times during the study-at baseline (pretreatment/wait), midtreatment/wait (week 8) and posttreatment/wait (week 15). Participants in the experimental arm will also complete weekly measures as part of the online program and they will be assessed at 3 and 6?months. Postwait, participants in the waitlist arm will be offered Internet Cognitive Therapy, and weekly and posttreatment data will also be collected for them. The trial aims to test whether Internet Cognitive Therapy is superior to waitlist in reducing social anxiety symptoms and in reducing the proportion of adolescents meeting criteria for SAD. Other outcomes of interest include depression and general anxiety symptoms. Acceptability of the online treatment will also be evaluated.DiscussionThis randomised controlled trial will provide preliminary evidence on whether this intervention, requiring relatively low levels of therapist input, is safe and clinically effective. If this is shown to be the case, Internet Cognitive Therapy for adolescents has the potential to provide a service to the large population of adolescents with untreated SAD.Trial registrationISRCTN Registry, ISRCTN15079139 . Version 1 registered on 06/02/2019.

Dataset Information

Cognitive bias modification for social anxiety in adults who stutter: a feasibility study of a randomised controlled trial.

Objective

Design

Participants

Intervention

Main outcome measures

Results

Conclusions

Trial registration number

Publications

Cognitive bias modification for social anxiety in adults who stutter: a feasibility study of a randomised controlled trial.

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