Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
Cognitive behaviour therapy for epilepsy: improving seizure control and quality of life - a pilot randomised controlled trial
Acronym
Study hypothesis
This is a pilot/feasibility study investigating the use of cognitive behaviour therapy (CBT) plus standard medical care vs standard medical care alone in improving seizure control and quality of life in adults with refractory epilepsy. Specifically this feasibility study will enable us to:
1. Evaluate the applicability of our CBT techniques to a broader sample of patients than in our previous work
2. Determine the acceptability of this randomisation and treatment approach in a sample of patients attending specialist epilepsy clinics, thereby informing recruitment rates when designing a later, larger randomised controlled trial (RCT)
3. Obtain information on treatment effect sizes to undertake power calculations for a larger RCT
Ethics approval
Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee, 04/07/2008, ref: LREC 08/H0807/44
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Epilepsy
Intervention
Following baseline recording of seizure frequency participants will be randomly assigned to one of two arms:
CBT (plus standard medical care):
CBT will comprise 12 weekly/fortnightly individual therapy sessions with the CBT therapist, over 4 months. Treatment will follow our prepared treatment manual, with homework tasks and seizure recordings reviewed at each session. In addition to seizure-specific interventions (e.g. development of countermeasures), more general cognitive behavioural therapeutic techniques will be employed to address the management of times of increased vulnerability to seizures and to improve patientsÂ’ overall physical and emotional well-being, with a view to relapse prevention. Handouts will be given to participants.
Standard medical care:
Participants will be seen by their epilepsy specialist in their regular clinic, depending on clinical need. As with the CBT group, we will monitor the number of appointments that participants have with their epilepsy specialist over the 4-month period and whether any medication changes are implemented during that time.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Monthly seizure frequency, monitored throughout the study. Total duration of follow-up: 12 weeks.
Secondary outcome measures
1. Liverpool Seizure Severity Scale at baseline, 8 and 12 weeks
2. Hospital Anxiety and Depression Scale at baseline, 8 and 12 weeks
3. Quality of Life in Epilepsy Inventory-31 (QOLIE-31) at baseline, 8 and 12 weeks
4. Health service usage for previous 8 weeks, assessed using the Client Service Receipt Inventory (CSRI) at baseline, beginning of treatment, 8-week follow-up and for previous 4 weeks at 12 week follow up
5. Health status, assessed by Euroqol EQ-5D at baseline, 8 and 12 weeks
Overall trial start date
01/12/2008
Overall trial end date
31/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, age 18-65 years
2. Clinical diagnosis (with supporting electroencephalography [EEG]) of epilepsy
3. A maximum of 40 seizures/month involving alteration/loss of consciousness (i.e. complex partial or generalised seizures) with no limit to simple partial seizure frequency
4. Stable medication for the month prior to recruitment
5. Able to attend weekly/fortnightly sessions
6. Willing to complete questionnaires regularly to monitor progress
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. History of, or current actual/suspected non-epileptic seizures
2. <2 seizures per month in each of the preceding four months
3. Active major psychiatric disorder
4. Drug/alcohol dependence
5. Receiving active vagus nerve stimulation (VNS) for seizures that has been adjusted within the previous 12 months
6. Insufficiently fluent in English to be able to undertake treatment and complete questionnaires without the assistance of an interpreter
7. Established learning disability (or where this has been measured formally, IQ <70)
Recruitment start date
01/12/2008
Recruitment end date
31/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychology
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
Institute of Psychiatry, King's College London (UK)
Sponsor details
c/o Mrs G Lambert
Research Governance/Clinical Trials Facilitator IoP/SLaM
R&D Office
PO05
De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Epilepsy Research UK (UK) (ref: P0805)
Alternative name(s)
ERUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary