التفاصيل البيبلوغرافية
| العنوان: |
COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): a multicentre randomised controlled trial protocol |
| المؤلفون: |
Goldstein, Laura, Mellers, John, Landau, Sabine, Stone, Jon, Carson, Alan, Medford, Nick, Reuber, Markus, Richardson, Mark, McCrone, Paul, Murray, Joanna, Chalder, Trudie |
| بيانات النشر: |
BioMed Central Ltd. |
| سنة النشر: |
2015 |
| المجموعة: |
BioMed Central |
| مصطلحات موضوعية: |
Dissociative seizures, Psychogenic non-epileptic seizures, Randomised controlled trial, Cognitive behavioural therapy, Clinical trial, Conversion disorder |
| الوصف: |
Background The evidence base for the effectiveness of psychological interventions for patients with dissociative non-epileptic seizures (DS) is currently extremely limited, although data from two small pilot randomised controlled trials (RCTs), including from our group, suggest that Cognitive Behavioural Therapy (CBT) may be effective in reducing DS occurrence and may improve aspects of psychological status and psychosocial functioning. Methods/Design The study is a multicentre, pragmatic parallel group RCT to evaluate the clinical and cost-effectiveness of specifically-tailored CBT plus standardised medical care (SMC) vs SMC alone in reducing DS frequency and improving psychological and health-related outcomes. In the initial screening phase, patients with DS will receive their diagnosis from a neurologist/epilepsy specialist. If patients are eligible and interested following the provision of study information and a booklet about DS, they will consent to provide demographic information and fortnightly data about their seizures, and agree to see a psychiatrist three months later. We aim to recruit ~500 patients to this screening stage. After a review three months later by a psychiatrist, those patients who have continued to have DS in the previous eight weeks and who meet further eligibility criteria will be told about the trial comparing CBT + SMC vs SMC alone. If they are interested in participating, they will be given a further booklet on DS and study information. A research worker will see them to obtain their informed consent to take part in the RCT. We aim to randomise 298 people (149 to each arm). In addition to a baseline assessment, data will be collected at 6 and 12 months post randomisation. Our primary outcome is monthly seizure frequency in the preceding month. Secondary outcomes include seizure severity, measures of seizure freedom and reduction, psychological distress and psychosocial functioning, quality of life, health service use, cost effectiveness and adverse events. We will include ... |
| نوع الوثيقة: |
report |
| اللغة: |
English |
| العلاقة: |
http://www.biomedcentral.com/1471-2377/15/98Test |
| الإتاحة: |
http://www.biomedcentral.com/1471-2377/15/98Test |
| حقوق: |
Copyright 2015 Goldstein et al. |
| رقم الانضمام: |
edsbas.1BF5E44E |
| قاعدة البيانات: |
BASE |
