Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Insomnia Severity Index (ISI) summary scores
研究概览
简要总结
This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must meet DSM-5 criteria for insomnia disorder.
- •Adults aged 18 to 80 years
- •Capable of giving written informed consent.
- •Sufficient fluency in the study site's language (i.e., German or French) to understand all study-related information.
排除标准
- •Unstable, progressive, or degenerative medical condition
- •Acute pain or poorly managed chronic pain
- •Suicidality
- •Uncontrolled psychiatric condition requiring treatment outside of study
- •Alcohol or drug abuse or dependency
- •Diagnosis of psychosis, bipolar disorder, autism, borderline personality disorder, or antisocial personality disorder
- •Clinical evidence of sleep disorders other than insomnia (e.g., sleep apnea, restless legs, periodic limb movements in sleep, parasomnia)
- •Evidence of intellectual disability
- •Regular intake of benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA)
- •Alteration of medication within 4 weeks prior to study treatment or planned alteration during the trial period (stable medication except BZD or BZDRA does not lead to exclusion)
- •Current other psychotherapy for insomnia
- •Known pregnancy or breastfeeding
- •Inability to comply with study procedure
- •Insufficient fluency in German or French to complete the study
结局指标
主要结局
Insomnia Severity Index (ISI) summary scores
时间窗: Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3)
次要结局
未报告次要终点
研究者
Christoph Nissen
Prof. Dr. med.
University of Geneva, Switzerland