At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of chronic insomnia according to ICSD-3 criteria
- ✓Willing to participate and provide signed informed consent
- ✕Unable to discontinue sleep-affecting medications for ≥1 week before and during study
- ✕History of alcohol or drug abuse
- ✕Major depressive disorder or other severe mental disorder
- ✕Dementia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effectiveness of Nonspecific Methods of Treatment and Zopiclone for Chronic Insomnia
In Brief
A Phase 2 clinical trial evaluating Brief behavioral therapy and Zopiclone for Insomnia Chronic. Completed, enrolled 42 participants.
Detailed Summary
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
Study Details
Timeline
Interventions
program included a question-and-answer part; a didactic presentation of sleep regulation mechanisms; the review of causes of onset and chronification of illness; an examination of patient's sleep log; explanation of sleep restriction method and prescription of individual regimen of sleep; explanation of stimulus control method; sleep hygiene education; discussion of relaxation techniques. Participants were supplied with 32 minute audio recording "Relaxation and refreshment session for insomnia" created for this study by Dr. A.Tabidze with verbal relaxing instructions with quiet musical composition behind it. Participants were instructed to listen to this recording in headphones each day for 2-week BBT-I period after laying into bed and turning the light off.
zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks