Phase 2
N=42
Effectiveness of BBT-I and Zopiclone for Chronic Insomnia
Insomnia Chronic
Bottom Line
View on ClinicalTrials.gov: NCT03339583 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Insomnia Severity Index — 18.6; 18.9; 13.1; 14.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Brief behavioral therapy (Behavioral); Zopiclone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- I.M. Sechenov First Moscow State Medical University
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index |
18.6; 18.9; 13.1; 14.0; 14.3; 16.1 | — |
| SECONDARY Beck Depression Inventory |
11.5; 9.3; 8.4; 9.4; 8.4; 9.8 | — |
| SECONDARY State Anxiety Subscale (STAI) |
45.1; 43.2; 43.8; 44.3; 45.5; 44.5 | — |
| SECONDARY Dysfunctional Beliefs About Sleep Scale |
105.2; 93.2; 83.8; 96.4; 84.76; 103.6 | — |
| SECONDARY Sleep Hygiene Index |
26.8; 25.2; 24.0; 25.0; 24.7; 25.5 | — |
| SECONDARY Pittsburgh Sleep Quality Index |
13.4; 11.9; 10.5; 11.3; 11.3; 12.7 | — |
| SECONDARY Trait Anxiety Subscale (STAI) |
48.7; 48.3; 48.3; 48.3; 48.6; 49.3 | — |
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
- 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;
- dementia;
- 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.
Data sourced from ClinicalTrials.gov (NCT03339583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.