Effectiveness of BBT-I and Zopiclone for Chronic Insomnia
Condition: Insomnia Chronic
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

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
    

Detailed description: 
      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.

      Treatment methods. BBT-I program includes two weekly one hour individual sessions; Hypnotic
      (zopiclone) in a dose of 7,5 mg has to be taken 30 minutes before bedtime for two weeks

      Measures Questionnaires. During the first visit patients underwent structured clinical
      interview and filled in self-report questionnaires: Beck Depression Inventory (BDI),
      State-trait anxiety inventory (STAI), Toronto Alexithymia Scale - short version (TAS-20) ,
      Big Five Questionnaire (BFQ-2R), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity
      Index (ISI), Dysfunctional beliefs about sleep scale (DBAS), Sleep hygiene index (SHI).

      During the next 4 visits participants repeatedly underwent diagnostic tests included BDI,
      STAI, PSQI, ISI, DBAS, SHI.

      Participants kept daily sleep diaries where they recorded bedtime and morning rise time,
      sleep onset latency (SOL), number of night awakenings and time of wakefulness after sleep
      onset before waking up (WASO) for the whole study period.

      On the last visit participants completed questionnaire for assessment of effectiveness of
      treatment along with diagnostic routine. Patients were asked to rank the effectiveness of
      proposed methods of treatment (didactic presentation, stimulus control, sleep restriction,
      relaxing recording and zopiclone) in ascending order from 1 to 5 points (5 seems most
      effective).

      Polysomnography. Participants underwent in-lab PSG (1 night without adaptation night) prior
      to the treatment in order to exclude other disorders producing subjective sleep complaints
      (sleep apnea, periodic limb movements disorder). Standard polysomnography montage including 6
      monopolar electroencephalography (EEG) channels; 1 submental electromyogram (EMG) channel; 2
      electrooculogram (EOG) channels; 2 EMG channels of the right and left tibialis anterior
      muscles; 1 electrocardiogram channel; oronasal airflow pressure; thoracic and abdominal
      efforts; respiratory sound; oxygen saturation; body position with videomonitoring was
      performed. The objective sleep measures included total sleep time (TST), sleep-onset latency,
      wake time after sleep onset (WASO), number of awakenings, sleep efficiency (the ratio of TST
      to time spent in bed multiplied on 100%, SE), percentage of sleep stages. PSG data were
      analysed according the 2007 American Academy of Sleep Medicine criteria including its
      revision in 2012.
    

Intervention name(s): Brief behavioral therapy; Zopiclone
Intervention type(s): Behavioral; Drug
Intervention description(s): 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
Other intervention name(s): BBT-I; hypnotic
Intervention MeSH terms: Zopiclone
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)
Primary purpose: Treatment
Keywords: chronic insomnia; brief behavioral treatment; behavioral treatment; insomnia severity index; predictors; treatment response