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

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2017 Jun 8

PMID 28587649

Citations 9

Authors

Emily J Robinson

Laura H Goldstein

Paul McCrone

Iain Perdue

Trudie Chalder

John D C Mellers

Mark P Richardson

Joanna Murray

Markus Reuber

Nick Medford

Jon Stone

Alan Carson

Sabine Landau

Affiliations

Soon will be listed here.

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).

Citing Articles

Reflections on the CODES trial for adults with dissociative seizures: what we found and considerations for future studies.

Goldstein L, Stone J, Reuber M, Landau S, Robinson E, Carson A BMJ Neurol Open. 2024; 6(1):e000659.

PMID: 38860230 PMC: 11163627. DOI: 10.1136/bmjno-2024-000659.

Six-month outcomes of the CODES randomised controlled trial of cognitive behavioural therapy for dissociative seizures: A secondary analysis.

Goldstein L, Robinson E, Chalder T, Reuber M, Medford N, Stone J Seizure. 2022; 96:128-136.

PMID: 35228117 PMC: 8970049. DOI: 10.1016/j.seizure.2022.01.016.

Cognitive-behavioural therapy compared with standardised medical care for adults with dissociative non-epileptic seizures: the CODES RCT.

Goldstein L, Robinson E, Pilecka I, Perdue I, Mosweu I, Read J Health Technol Assess. 2021; 25(43):1-144.

PMID: 34196269 PMC: 8273679. DOI: 10.3310/hta25430.

Psychosocial interventions for conversion and dissociative disorders in adults.

Ganslev C, Storebo O, Callesen H, Ruddy R, Sogaard U Cochrane Database Syst Rev. 2020; 7:CD005331.

PMID: 32681745 PMC: 7388313. DOI: 10.1002/14651858.CD005331.pub3.

The experience of trial participation, treatment approaches and perceptions of change among participants with dissociative seizures within the CODES randomized controlled trial: A qualitative study.

Read J, Jordan H, Perdue I, Purnell J, Murray J, Chalder T Epilepsy Behav. 2020; 111:107230.

PMID: 32640411 PMC: 7581898. DOI: 10.1016/j.yebeh.2020.107230.

References

Duncan R, Razvi S, Mulhern S . Newly presenting psychogenic nonepileptic seizures: incidence, population characteristics, and early outcome from a prospective audit of a first seizure clinic. Epilepsy Behav. 2011; 20(2):308-11. DOI: 10.1016/j.yebeh.2010.10.022. View

Razvi S, Mulhern S, Duncan R . Newly diagnosed psychogenic nonepileptic seizures: health care demand prior to and following diagnosis at a first seizure clinic. Epilepsy Behav. 2011; 23(1):7-9. DOI: 10.1016/j.yebeh.2011.10.009. View

Goldstein L, Mellers J, Landau S, Stone J, Carson A, Medford N . COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): a multicentre randomised controlled trial protocol. BMC Neurol. 2015; 15:98. PMC: 4482314. DOI: 10.1186/s12883-015-0350-0. View

Al Marzooqi S, Baker G, Reilly J, Salmon P . The perceived health status of people with psychologically derived non-epileptic attack disorder and epilepsy: a comparative study. Seizure. 2004; 13(2):71-5. DOI: 10.1016/s1059-1311(03)00158-4. View

Baldwin S, Murray D, Shadish W, Pals S, Holland J, Abramowitz J . Intraclass correlation associated with therapists: estimates and applications in planning psychotherapy research. Cogn Behav Ther. 2011; 40(1):15-33. PMC: 3650614. DOI: 10.1080/16506073.2010.520731. View

Dunn G, Maracy M, Dowrick C, Ayuso-Mateos J, Dalgard O, Page H . Estimating psychological treatment effects from a randomised controlled trial with both non-compliance and loss to follow-up. Br J Psychiatry. 2003; 183:323-31. DOI: 10.1192/bjp.183.4.323. View

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011; 20(10):1727-36. PMC: 3220807. DOI: 10.1007/s11136-011-9903-x. View

LaFrance Jr W, Baird G, Barry J, Blum A, Frank Webb A, Keitner G . Multicenter pilot treatment trial for psychogenic nonepileptic seizures: a randomized clinical trial. JAMA Psychiatry. 2014; 71(9):997-1005. DOI: 10.1001/jamapsychiatry.2014.817. View

Brown R, Reuber M . Psychological and psychiatric aspects of psychogenic non-epileptic seizures (PNES): A systematic review. Clin Psychol Rev. 2016; 45:157-82. DOI: 10.1016/j.cpr.2016.01.003. View

10.

Reuber M, Mayor R . Recent progress in the understanding and treatment of nonepileptic seizures. Curr Opin Psychiatry. 2012; 25(3):244-50. DOI: 10.1097/YCO.0b013e3283523db6. View

11.

Brazier J, Roberts J . The estimation of a preference-based measure of health from the SF-12. Med Care. 2004; 42(9):851-9. DOI: 10.1097/01.mlr.0000135827.18610.0d. View

12.

Duncan R, Oto M, Wainman-Lefley J . Mortality in a cohort of patients with psychogenic non-epileptic seizures. J Neurol Neurosurg Psychiatry. 2012; 83(7):761-2. DOI: 10.1136/jnnp-2012-302900. View

13.

Borm G, Fransen J, Lemmens W . A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007; 60(12):1234-8. DOI: 10.1016/j.jclinepi.2007.02.006. View

14.

Ware Jr J, Kosinski M, Keller S . A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996; 34(3):220-33. DOI: 10.1097/00005650-199603000-00003. View

15.

White P, Goldsmith K, Johnson A, Potts L, Walwyn R, DeCesare J . Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011; 377(9768):823-36. PMC: 3065633. DOI: 10.1016/S0140-6736(11)60096-2. View

16.

Sharpe M, Walker J, Williams C, Stone J, Cavanagh J, Murray G . Guided self-help for functional (psychogenic) symptoms: a randomized controlled efficacy trial. Neurology. 2011; 77(6):564-72. PMC: 3149156. DOI: 10.1212/WNL.0b013e318228c0c7. View

17.

Mayor R, Smith P, Reuber M . Management of patients with nonepileptic attack disorder in the United Kingdom: a survey of health care professionals. Epilepsy Behav. 2011; 21(4):402-6. DOI: 10.1016/j.yebeh.2011.05.019. View

18.

Goldstein L, Chalder T, Chigwedere C, Khondoker M, Moriarty J, Toone B . Cognitive-behavioral therapy for psychogenic nonepileptic seizures: a pilot RCT. Neurology. 2010; 74(24):1986-94. PMC: 2905892. DOI: 10.1212/WNL.0b013e3181e39658. View

19.

White I, Horton N, Carpenter J, Pocock S . Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011; 342:d40. PMC: 3230114. DOI: 10.1136/bmj.d40. View

20.

Martlew J, Pulman J, Marson A . Psychological and behavioural treatments for adults with non-epileptic attack disorder. Cochrane Database Syst Rev. 2014; (2):CD006370. PMC: 11032749. DOI: 10.1002/14651858.CD006370.pub2. View