Effectiveness of Nonspecific Methods of Treatment and Zopiclone for Chronic Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
Background: Importance of chronic insomnia (CI) problem is determined by its high prevalence rate, comorbidity and resistance to the treatment. Although cognitive behavior treatment of insomnia (CBT-I) remains the recommended treatment for CI it has disadvantages of time consuming and low treatment response. Hence shortened and simplified behavioral approaches such as Brief Behavioral therapy of insomnia (BBT-I) are developed. The aim of the present study is to test the effectiveness of BBT-I program for chronic insomnia in comparison with zopiclone in Russian population. The anthropometric, psychological and polysomnographic characteristics of patients were measured to find predictors of effectiveness of each method.
Participants: 42 adults (14 males, 28 females, mean age 54 years) meeting the criteria for CI according International classification of sleep disorders-3 Methods: Participants were randomized into two groups. Each group passed 2-week courses of treatment by brief behavior treatment of insomnia (BBT-I) and zopiclone in different orders with 2-week washout period between the courses. Participants underwent in-lab polysomnography prior to the treatment and completed questionnaires (Insomnia Severity Index (ISI), Dysfunctional beliefs about sleep scale (DBAS), Beck Depression Inventory (BDI) and others) in the beginning and the end of each course
详细描述
The study had a crossover design implying that every patient underwent two different treatment courses in random sequence: hypnotic or structured educational program (BBT-I) delivered in two sessions.
Each treatment course was separated by 2-weeks washout period that provided the opportunity to evaluate the sustainability of treatment effect.
Before and after each treatment course and after each washout period subjects completed set of questionnaires.
The total duration of the study was 8 weeks in which 6 visits including 1 night polysomnography (PSG), 2 face-to-face structured educational program sessions and 5 diagnostic interviews have been performed.
Participants A sample of 42 adults (14 males, 28 females, mean age 54 years from 29 to 80 years) meeting the criteria for chronic insomnia according ICSD-3 was recruited from outpatient care of Department of sleep medicine of University Hospital №3 of I.M. Sechenov First Moscow State Medical University. All participants were informed about the nature, purpose, risks, and discomforts that could arise from their participation, and about their right to withdraw at any time. Subjects documented their willingness to participate by signing the informed consent form, approved by local Ethic Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •meeting the criteria for chronic insomnia according ICSD-3 willingness to take part in the study and signed informed consent form
排除标准
- •unability to stop taking medications that have a proven impact on sleep at least one week before and during the study;
- •history of alcohol or drug abuse;
- •major depressive disorder or other severe mental disorder identified by a clinical assessment and medical history;
- •pregnancy or lactation;
- •shift or night work;
- •medical problems that would be a direct cause of sleep complaints: moderate/severe sleep apnea, defined as an apnea-hypopnea index of ≥15 events per hour, periodic limb movement disorder defined as a periodic leg movement index ≥15 events per hour or restless legs syndrome;
- •other serious chronic conditions or exacerbation of chronic disorder preventing further participation.
研究组 & 干预措施
zopiclone first group
underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy
干预措施: Brief behavioral therapy (Behavioral)
zopiclone first group
underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy
干预措施: Zopiclone (Drug)
BBT-I first group
received two-week brief behavioral therapy followed by medication therapy (zopiclone).
干预措施: Brief behavioral therapy (Behavioral)
BBT-I first group
received two-week brief behavioral therapy followed by medication therapy (zopiclone).
干预措施: Zopiclone (Drug)
结局指标
主要结局
Insomnia Severity Index
时间窗: For BBT-I-first group: on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/Month 1); For zopiclone-first group: after washout period (Day 28/Week 4/Month 1) after second treatment course (Day 42/Week 6/Month 2)
self reported insomnia symptoms severity by Insomnia severity index . Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
次要结局
- Beck Depression Inventory(on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2))
- State Anxiety Subscale (STAI)(on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2))
- Dysfunctional Beliefs About Sleep Scale(on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2))
- Sleep Hygiene Index(on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2))
- Pittsburgh Sleep Quality Index(on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2))
- Trait Anxiety Subscale (STAI)(on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2))
研究者
Polina Pchelina
Postgraduate student. Institute of Professional Education, Chair of Neurology. I.M. Sechenov First Moscow State Medical University
I.M. Sechenov First Moscow State Medical University