Cognitive behaviour therapy for epilepsy: improving seizure control and quality of life

ISRCTN	ISRCTN31786019
DOI	https://doi.org/10.1186/ISRCTN31786019
Secondary identifying numbers	1.0

Submission date: 26/11/2008
Registration date: 10/12/2008
Last edited: 07/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Laura H Goldstein
Scientific

Department of Psychology
Institute of Psychiatry
King's College London
PO77
De Crespigny Park
London
SE5 8AF
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Cognitive behaviour therapy for epilepsy: improving seizure control and quality of life - a pilot randomised controlled trial
Study objectives	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(s)	Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee, 04/07/2008, ref: LREC 08/H0807/44
Health condition(s) or problem(s) studied	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 patients 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
Primary outcome measure	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 study start date	01/12/2008
Completion date	31/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	40
Total final enrolment	26
Key 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
Key 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)
Date of first enrolment	01/12/2008
Date of final enrolment	31/03/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Psychology

London
SE5 8AF
United Kingdom

Sponsor information

Institute of Psychiatry, King's College London (UK)
University/education

c/o Mrs G Lambert
Research Governance/Clinical Trials Facilitator IoP/SLaM
R&D Office
PO05
De Crespigny Park
London
SE5 8AF
England
United Kingdom

Website	http://www.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Charity

Epilepsy Research UK (UK) (ref: P0805)
Private sector organisation / Other non-profit organizations

Alternative name(s): ERUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		07/07/2017	07/08/2020	No	No

Additional files

ISRCTN31786019_BasicResults_07Jul2017.pdf: uploaded 07/08/2020

Editorial Notes

07/08/2020: The basic results of this trial have been uploaded as an additional file.
11/05/2016: No publications found, verifying study status with principal investigator.