Effectiveness of BBT-I and Zopiclone for Chronic Insomnia
Condition: Insomnia Chronic
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Brief behavioral therapy; Zopiclone
Intervention description: 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
Intervention MeSH terms: Zopiclone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Study design implied that every patient underwent two different treatment courses in random sequence: hypnotic or structured educational program (BBT-I) delivered in two sessions.
Subjects were randomly assigned to one of treatment sequences by card sorting method. Patients of the zopiclone-first group underwent the medication therapy for the first two weeks followed by educational program. Patients of the BBT-I-first group received two-week educational program followed by medication therapy.
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.
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: chronic insomnia; brief behavioral treatment; behavioral treatment; insomnia severity index; predictors; treatment response

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
    

Eligibility criteria:

        Inclusion Criteria:

        meeting the criteria for chronic insomnia according ICSD-3 willingness to take part in the
        study and signed informed consent form

        Exclusion Criteria:

          1. unability to stop taking medications that have a proven impact on sleep at least one
             week before and during the study;

          2. history of alcohol or drug abuse;

          3. major depressive disorder or other severe mental disorder identified by a clinical
             assessment and medical history;

          4. dementia;

          5. pregnancy or lactation;

          6. shift or night work;

          7. 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;

          8. other serious chronic conditions or exacerbation of chronic disorder preventing
             further participation.