Pilot Study Evaluating the Efficacy of the Management of an Online Program of Cognitive Behavioral Therapy for Primary Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- insomnia severity measured
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the management of chronic primary insomnia patients by a computer program guidance of behavioral and cognitive therapies for insomnia (BCT-I).
详细描述
Chronic insomnia is a common sleep disorder (prevalence = 10%) and a risk identified on the physical and mental health. Currently, the treatment involves the prescription of drug treatments by general practitioners, which may be unsuitable for the medium term. It is better to turn to Behavioral and Cognitive Therapies for Insomnia (BCT-I) in the case of primary chronic insomnia. The objective of this study is to evaluate the effectiveness of a computer program guidance BCT-I in patients with chronic primary insomnia. This biomedical research psychotherapeutic assessment will be randomized, controlled versus psychoeducation and conducted in 46 patients with chronic primary insomnia (defined according to Diagnostic and Statistical Manual-5) for which a supported by BCT-I is indicated.
The 46 patients will be randomized into two groups. The subjects in Group 1 will be supported by BCT-I online. And the subjects in group 2 will receive psychoeducation. All patients will be followed by the research team for three months, during which 3 visits (V0 = pre-selection; V1 = visit of randomization and start of the program; V2 = 3 months follow-up visit and end of the study) will be performed in the University Hospital Sleep Disorder Unit of Montpellier. Patients in Group 1 will conduct BCT-I online at home therapy. Patients in group 2 will receive a structured 45-minute session information insomnia (psychoeducation = work performed daily by clinicians in charge of insomnia problems) to the visit 1. All patients in the study will be equipped 2 sensors for the registration of sleep data.
The primary endpoint will be based on the severity of insomnia measured by the ISI after the last online psychotherapy session (3 months) between the 2 groups of patients (BCT-I online and without treatment - psychoeducation ). The analyse efficacity to be conducted by intention to treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 20 and 65
- •disorder diagnosis of chronic insomnia (according to Diagnostic and Statistical Manual-5)
- •sleep efficiency <80%
- •Index severe insomnia: ISI> 14/28
- •have a computer at home
- •Practicing internet regularly in everyday life
- •have a personal email address
排除标准
- •Clinically suffer from insomnia comorbid linked to other sleep disorders
- •Presenting an unbalanced psychiatric disorder
- •Have Score Beck Depression Inventory (BDI-II) >29
- •Have neurological disorders
- •Have severe medical conditions that can affect the quality of sleep
- •Have Hypnotic, Anxiolytic, antidepressants Treatment > 2
- •Have antipsychotics, opioids, anticonvulsants, anti-parkinson treatment
- •Having a disorder of substance use (alcohol, drugs) in the last 6 months
- •Having undertaken a meridian trance journey (± 3H) in the preceding month or during the study period
- •Already be treated with CBT-I
研究组 & 干预措施
cognitive behavioral therapy online
patients receive cognitive behavioral therapy via an online program
干预措施: cognitive behavioral therapy online (Other)
no cognitive behavioral therapy online
patients receive psychoeducation by a doctor
干预措施: psychoeducation (Other)
结局指标
主要结局
insomnia severity measured
时间窗: 100 days
The primary endpoint will focus on the severity of insomnia measured by the Index severe insomnia (ISI) at the end of the last session of CBT (3 months) between the 2 groups of patients (CBT-I online and psychoeducation).
次要结局
- sleep efficiency(100 days)
- duration of night wakings(100 days)
- adherence to CBT-I program online(100 days)
- Sleep quality(100 days)
- Sleep latency(100 days)
- total sleep time(100 days)
- quantity of hypnotic treatment(100 days)