ArticleBMJ open2023
Content or context? A study protocol for a three-arm parallel randomised controlled trial of R
Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed, 6 citations in OpenAlex.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFunctional seizures (FS) mimic epilepsy but are not caused by epileptic electrical activity in the brain and are believed to have a psychological origin. There is a well-documented gap between the needs of patients with FS and available therapeutic resources. While there is potential for reducing seizure burden in patients via psychosocial intervention, there is no evidence-based care pathway or consistent availability of treatment and no effective pharmacological treatment. The objective of this study is to investigate the clinical efficacy and tolerability of a novel internet-based intervention in reducing seizure frequency. METHODS AND ANALYSIS: A 3-arm parallel randomised controlled trial will compare the efficacy of brief guided internet-based therapy to unguided internet-based therapy and to standard care. Approximately 100 participants with FS will be recruited, with diagnostic criteria based on gold standard video-electroencephalogram (v-EEG) monitoring; patients will be randomly assigned to one of the three study arms. The primary study outcome will be FS frequency at 6 weeks and at follow-up (6 and 12 months) compared with baseline. Seizure frequency will be modelled using Poisson regression. Secondary outcomes include psychosocial functioning, healthcare resource usage, anxiety, depression, somatisation and life impact. Between-group differences will be evaluated using analysis of variance. Analysis of covariance will estimate within-group changes on secondary outcomes. Cognitive and psychological factors will be used as predictors of seizure reduction in exploratory analyses. A qualitative survey using a semi-structured interview will use thematic analyses to explore participants' treatment experiences, their impressions of FS management and perceived mechanisms for change. ETHICS AND DISSEMINATION: The study was approved by the Human Research and Ethics Committee of the Alfred Hospital Human Research Ethics Committee as part of the Australian Multisite Ethics approval system. Results of the study will be presented at national and international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12622000262707.
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