Condition category
Nervous System Diseases
Date applied
26/11/2008
Date assigned
10/12/2008
Last edited
11/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Laura H Goldstein

ORCID ID

Contact details

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

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

http://www.kcl.ac.uk

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

Publication citations

Additional files

Editorial Notes

11/05/2016: No publications found, verifying study status with principal investigator.