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COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial.

ABSTRACT: BACKGROUND:Dissociative seizures (DSs), also called psychogenic non-epileptic seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial is an evaluation of a specifically tailored psychological intervention with the aims of reducing seizure frequency and severity and improving psychological well-being in adults with DS. The aim of this paper is to report in detail the quantitative and economic analysis plan for the CODES trial, as agreed by the trial steering committee. METHODS:The CODES trial is a multicentre, pragmatic, parallel group, randomised controlled trial performed to evaluate the clinical effectiveness and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) compared with SMC alone for adult outpatients with DS. DISCUSSION:The objectives and design of the trial are summarised, and the aims and procedures of the planned analyses are illustrated. The proposed analysis plan addresses statistical considerations such as maintaining blinding, monitoring adherence with the protocol, describing aspects of treatment and dealing with missing data. The formal analysis approach for the primary and secondary outcomes is described, as are the descriptive statistics that will be reported. This paper provides transparency to the planned inferential analyses for the CODES trial prior to the extraction of outcome data. It also provides an update to the previously published trial protocol and guidance to those conducting similar trials. TRIAL REGISTRATION:ISRCTN registry ISRCTN05681227 (registered on 5 March 2014); ClinicalTrials.gov NCT02325544 (registered on 15 December 2014).

SUBMITTER: Robinson EJ

PROVIDER: S-EPMC5461767 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial.

Robinson Emily J EJ Goldstein Laura H LH McCrone Paul P Perdue Iain I Chalder Trudie T Mellers John D C JDC Richardson Mark P MP Murray Joanna J Reuber Markus M Medford Nick N Stone Jon J Carson Alan A Landau Sabine S

Trials 20170606 1

<h4>Background</h4>Dissociative seizures (DSs), also called psychogenic non-epileptic seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial is an evaluation of a specifically tailored psychological intervention with the aims of reducing seizure frequency and severity and improvin ...[more]

PMID: 28587649

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Project description:BackgroundThe evidence base for the effectiveness of psychological interventions for patients with dissociative non-epileptic seizures (DS) is currently extremely limited, although data from two small pilot randomised controlled trials (RCTs), including from our group, suggest that Cognitive Behavioural Therapy (CBT) may be effective in reducing DS occurrence and may improve aspects of psychological status and psychosocial functioning.Methods/designThe study is a multicentre, pragmatic parallel group RCT to evaluate the clinical and cost-effectiveness of specifically-tailored CBT plus standardised medical care (SMC) vs SMC alone in reducing DS frequency and improving psychological and health-related outcomes. In the initial screening phase, patients with DS will receive their diagnosis from a neurologist/epilepsy specialist. If patients are eligible and interested following the provision of study information and a booklet about DS, they will consent to provide demographic information and fortnightly data about their seizures, and agree to see a psychiatrist three months later. We aim to recruit ~500 patients to this screening stage. After a review three months later by a psychiatrist, those patients who have continued to have DS in the previous eight weeks and who meet further eligibility criteria will be told about the trial comparing CBT + SMC vs SMC alone. If they are interested in participating, they will be given a further booklet on DS and study information. A research worker will see them to obtain their informed consent to take part in the RCT. We aim to randomise 298 people (149 to each arm). In addition to a baseline assessment, data will be collected at 6 and 12 months post randomisation. Our primary outcome is monthly seizure frequency in the preceding month. Secondary outcomes include seizure severity, measures of seizure freedom and reduction, psychological distress and psychosocial functioning, quality of life, health service use, cost effectiveness and adverse events. We will include a nested qualitative study to evaluate participants' views of the intervention and factors that acted as facilitators and barriers to participation.DiscussionThis study will be the first adequately powered evaluation of CBT for this patient group and offers the potential to provide an evidence base for treating this patient group.Trial registrationCurrent Controlled Trials ISRCTN05681227 ClinicalTrials.gov NCT02325544.

Project description:ObjectivesLittle is known about the experiences of therapists delivering psychotherapy for patients with dissociative seizures (DS), a complex disorder associated with a range of comorbid psychosocial and mental health difficulties. This study set out to explore therapists' experiences of delivering DS-specific, manualized cognitive behavioral therapy (CBT) to adults with DS within the context of a randomized control trial.MethodsInterviews were conducted with 12 therapists involved in the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial and were analyzed using thematic framework analysis (TFA).ResultsSix main themes emerged, namely 1) aspects of the intervention that were favored, while others were not always considered applicable; 2) multiple and complex difficulties faced by patients; 3) working effectively within the protocol; 4) limitations of the protocol; 5) significance of formulation; and 6) quality of standardized medical care (SMC) and difficulties of diagnosis delivery. These addressed valued aspects of the intervention, complexities of the patient group, and experiences working within a structured treatment protocol. Family involvement and psychoeducation were highlighted as important components; the applicability of graded exposure techniques, however, was restricted by patients' apparent emotional avoidance. The structure provided by the treatment protocol was valued, but flexibility was important to individualize treatment in complex cases. A comprehensive formulation was fundamental to this. The initial diagnostic explanation provided by neurologists and psychiatrists was generally considered beneficial, with patients often perceived to enter therapy with a better understanding of their condition.ConclusionsThis study demonstrated that the DS-specific CBT intervention met with general approval from therapists who also highlighted some practical challenges. Because of the nature of the condition, the need for experience of working with complex patients should be considered when applying the intervention to individual cases. Setting the CBT intervention in the context of a structured care pathway involving neurology and psychiatry may facilitate the therapeutic process.

Project description:Background: People with non-epileptic seizures (NES) describe challenging relationships with health professionals, and explain negative interactions as common and expected. Despite these difficulties, little is known about how people with NES experience difficult healthcare encounters. Methods: Using a thematic discourse analysis approach, we analysed the free-text survey responses of 135 people with NES and asked: what kind of challenges do people living with this condition encounter when interacting with health professionals, and how do they experience the consequences of difficult interactions? We explore their experiences by interpreting the latent meaning of participants' texts from a social-constructionist perspective on health and illness. Results: The overarching narrative depicts a fundamental breakdown in patient-provider relationships. According to our data, the negative experiences of study participants emerge from more than practitioners' lack of awareness of NES and access to information about the condition - to the extent that it is available. In examining the challenges people with NES encounter when interacting with health professionals, their main experiences centre on blame and humiliation. When exploring their experiences, theories of stigma serve as a useful theoretical framework. Conclusions: Normative judgements arising from psychogenic understandings of NES are stigmatising and restrict professional displays of respectful (patient-centred) care. Those with the condition depict being negatively stereotyped, illegitimated and held morally culpable by health professionals. Perceived to lack medical, moral and credible status, participants describe practitioners who treat them with disrespect, and some recount conduct that defies all ethical and professional obligations and standards. These encounters can have wide-ranging adverse consequences for patients: emotionally, physically, and for their future healthcare. The quality of healthcare interactions for people with NES requires urgent improvements. In addition to increased awareness of the condition, practitioners need to be conscious of making and acting on adverse moral appraisals when interacting with this patient group.

Dataset Information

COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial.

Publications

COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial.

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