A Randomised Controlled Trial Comparing the Efficacy of Cognitive Behavioral Therapy vs Yoga Nodra in Persons with Psychogenic Non-epileptic Seizures
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in monthly episode frequency, measured at baseline and the end of study- i.e. 6 months
研究概览
简要总结
Brief methodology:
Study population: Patients attending inpatient or outpatient services and wards of department of Neurology and Psychiatry, AIIMS, New Delhi diagnosed with PNES and fulfilling the inclusion criteria will be enrolled
Sample Size: Since it is a pilot study, we will employ a total of 50 patients who will be randomised into the two arms. After getting written informed consent by patient or caregiver, patient will be randomised to interventional arm A and B.
Randomization: This will be based on computer generated random sequence allocation
Arm A- CBT + Yoga Nidra
Arm B- CBT+ Sham yoga nidra
CBT will be provided to the patients via an online module which encompasses 12 sessions, weekly one session which lasts for almost an hour. Yoga nidra practice is taught using copyrighted audio CD from Bihar school of Yoga after prior permission. Sham Yoga nidra involves an exercise that mimics yoga nidra but patients are not given instructions on the corresponding breath modulation and synchronization, body awareness and focus.
The interventions in either arms will be provided for a period of 3 months and outcome is assessed at the end of 6 months.
Primary outcome measure: Reduction in monthly episode frequency, measured at baseline and the end of study- i.e. 6 months
Secondary outcome measures:
i) Duration of freedom from episodes
ii) Change in quality of life, measured by QOLIE-31
iii) Reduction in use of anti-seizure drugs
iv) Improvement in psychological comorbidities, measured by HAMA and HAMD scales at baseline and end of 6 months
v) Cost difference between CBT and YN
Data will be analyzed by using statistical software SPSS version 16 (SPSS Inc., Illinois, Chicago) for statistical analysis. Descriptive statistics will be used to summarize the
baseline characteristics of the study population. Appropriate
statistical tests will be used to analyse the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •i)Persons aged 18-70 years ii) Clinical diagnosis of PNES confirmed by home video and a similar episode induced in video-EEG with no ictal correlates.
排除标准
- •: i) A coexistent diagnosis of epilepsy (past/current) ii) Current drug/alcohol dependence iii) Patients with episode frequency < 6 months iv) Patients with coexisting non-neurologic comorbidities like chronic cardiac, renal and other systemic diseases v)Patients not giving consent vi) Patients with intellectual disability vii) Patients with acute psychosis.
结局指标
主要结局
Reduction in monthly episode frequency, measured at baseline and the end of study- i.e. 6 months
时间窗: 0, 6 months
次要结局
- i)Duration of freedom from episodes(ii)Change in quality of life, measured by QOLIE-31)