Clinical Trial: Comparing Different Treatments in Reducing Dissociative Seizure Occurrence

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: COgnitive Behavioural Therapy Versus Standardised Medical Care for Adults With Dissociative Non-Epileptic Seizures: A Multicentre Randomised Controlled Trial (CODES)

Brief Summary:

The study will test the hypothesis that Cognitive Behavioural Therapy plus Standardised Medical Care (SMC) will have greater clinical and cost effectiveness than SMC alone in treating adult patients with dissociative seizures which had not initially ceased after diagnosis.

About 12-20% of patients who attend neurology or specialist epilepsy clinics because of seizures do not in fact have epilepsy. Most of these people have what are referred to as dissociative (non-epileptic) seizures (DS). This means that they have episodes that resemble epileptic seizures but which have no medical reason for their occurrence and instead are due to psychological factors. In younger adults DS are about four times more common in women than men. A high percentage of these people will have other psychological or psychiatric problems and may have other medically unexplained symptoms. It is generally thought that people with DS will benefit from psychological treatments. However, studies on this have been small or have not compared the psychological therapy with the treatment people normally receive (standardised medical care). There is some evidence that cognitive behavioural therapy (CBT), which is a widely accepted talking therapy that focuses on the person's thoughts, emotions and behaviour, as well as considering the physical reactions and sensations that may occur in people's bodies, may lead to a reduction in how often people have DS. The investigators have previously developed a CBT package for people with DS. In a relatively small study by our group, published in 2010, people receiving CBT overall showed greater reduction in how often they had their DS. The investigators are now conducting a larger study, across several different hospitals, to obtain more definite results about the effectiveness of our CBT approach for DS.

The investiga

Detailed Summary:

There is an initial observational phase to this study followed by a parallel group, two-arm multi-centre pragmatic randomised controlled trial (interventional phase).

In the observational phase patients will be given their diagnosis of dissociative seizures by a neurologist/epilepsy specialist and will be told about the CODES study. In addition to a leaflet on dissociative seizures they will, if interested in the study and are willing to be referred to a psychiatrist, be given an information sheet about DS and about the study and the doctor will document their agreement to be contacted by a research nurse/worker. This person will arrange to contact them, clarify study details, obtain informed consent, collect demographic details and explain seizure diary recording. They will then contact the patient fortnightly (bi-weekly)for seizure data. The investigators initially aim to recruit ~500 patients at this stage.

After 3 months the patient will be reviewed by a neuropsychiatrist/ liaison psychiatrist/ psychiatrist with interest in DS who will undertake a clinical assessment, review the patient's eligibility for the interventional phase of the study and if eligible will explain the RCT. Patients will be given a further leaflet on DS and a Participant Information Sheet and the psychiatrist will document interested patients' willingness to again be contacted by a research nurse/worker. That person will then explain the RCT in greater detail, obtain informed consent, undertake a baseline assessment including a MINI and instruct patients to keep seizure records for which data will be collected fortnightly. .Randomisation of between 298 and 356 people (depending on follow-up rates) to either CBT plus standardised medical care (SMC) or to SMC alone will occur after informed consent has been obtained and baseline measures have been c
Sponsor: King's College London

Current Primary Outcome: Change in seizure frequency [ Time Frame: Baseline, 6 & 12 months post randomisation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in informant rating [ Time Frame: 6 & 12 months post randomisation ]
  A rating by an informant as to whether compared to study entry seizure frequency is worse the same better or whether they are seizure free.
• Change in self-rated seizure severity [ Time Frame: Baseline, 6 & 12 months post randomisation ]
  Two items from the Seizure Severity Scale (Cramer et al., 2002), asking how severe and bothersome DS were in the past month.
• Seizure freedom [ Time Frame: 12 months post randomisation ]
  Patient's self reported longest period of seizure freedom between the 6- and 12-month follow-up and whether or not the patient is seizure free in the last 3 months of the trial
• >50% reduction in seizure frequency [ Time Frame: 6 and 12 months post randomisation ]
  The number of patients in each group who at the 6- and 12-month follow-up show >50% reduction in seizure frequency, compared to baseline
• Change in Quality of life (QoL) [ Time Frame: Baseline, 6 & 12 months post randomisation ]
  Health-related QoL using the SF-12v2 (Ware et al.,1996)
• Change in QALYs [ Time Frame: Baseline, 6 & 12 months post randomisation ]
  We will use EQ-5D-5L (EuroQol group, 1990), a 5-domain, 5-level, multi-attribute scale
• Change in psychosocial functioning [ Time Frame: Baseline, 6 & 12 months post randomisation ]
  Work and Social Adjustment Scale (Mundt et al 2002)
• Change in psychiatric symptoms and psychological distress [ Time Frame: Baseline, 6 & 12 months post randomisation ]
  We will measure anxiety, depression and somatisation with the GAD7 (Spitzer et al., 2006), PHQ9 (Kroenke et al., 2001) and an extended PHQ15 (Kroenke et al., 2002; Sharpe et al., 2010), derived from the Patient Health Questionnaire which reflects DSM-IV diagnoses.We will also use a general measure of psychological distress, the CORE-10 (Connell & Barkham, 2007); this assesses self-reported global psychological distress.
• Change in patients self-rated global outcome and satisfaction with treatment [ Time Frame: 6 & 12 months post randomisation ]
  CGI Clinical Global Impression (Guy 1976) change score yields a self-rated global measure of change
• Clinician rating of change [ Time Frame: End of treatment or 12 month follow-up ]
  The CGI change scale will be rated by CBT therapists at the end of session 12 and by the SMC doctor at the 12-month follow-up.
• Change in health service use and informal care (self-report) [ Time Frame: Baseline, 6 and 12 months post randomisation ]
  Adapted Client Service Receipt Inventory (Beecham & Knapp, 2001).
• Change in health service use [ Time Frame: Baseline, 6 and 12 months post randomisation ]
  Linkage data sets from NHS Health and Social Care Information Centre (Hospital Episode Statistics) eDRIS (NHS National Services Scotland Information Services Division (ISD) and Wales (NHS Wales Informatics Service)

Original Secondary Outcome: Same as current

Information By: King's College London

Dates:
Date Received: December 15, 2014
Date Started: October 2014
Date Completion: July 2018
Last Updated: June 24, 2016
Last Verified: February 2016