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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 August 2020 |
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Main ID: |
ISRCTN31786019 |
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Date of registration:
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10/12/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cognitive behaviour therapy for epilepsy: improving seizure control and quality of life
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Scientific title:
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Cognitive behaviour therapy for epilepsy: improving seizure control and quality of life - a pilot randomised controlled trial |
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Date of first enrolment:
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01/12/2008 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN31786019 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Laura H
Goldstein |
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Address:
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Department of Psychology
Institute of Psychiatry
King's College London
PO77
De Crespigny Park
SE5 8AF
London
United Kingdom |
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Key inclusion & exclusion criteria
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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
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)
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy
Nervous System Diseases
Epilepsy
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Intervention(s)
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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.
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Primary Outcome(s)
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Monthly seizure frequency, monitored throughout the study. Total duration of follow-up: 12 weeks.
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Epilepsy Research UK (UK) (ref: P0805)
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Ethics review
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Status:
Approval date:
Contact:
Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee, 04/07/2008, ref: LREC 08/H0807/44
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2010 |
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URL:
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