Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of BBT-I and Zopiclone for Chronic Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339583
Recruitment Status : Completed
First Posted : November 13, 2017
Results First Posted : June 17, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Polina Pchelina, I.M. Sechenov First Moscow State Medical University

Brief 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


Condition or disease Intervention/treatment Phase
Insomnia Chronic Behavioral: Brief behavioral therapy Drug: Zopiclone Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Official Title: Effectiveness of Nonspecific Methods of Treatment and Zopiclone for Chronic Insomnia
Actual Study Start Date : April 7, 2015
Actual Primary Completion Date : March 14, 2017
Actual Study Completion Date : March 14, 2017

Arm Intervention/treatment
Experimental: zopiclone first group
underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy
Behavioral: Brief behavioral therapy
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.
Other Name: BBT-I

Drug: Zopiclone
zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
Other Name: hypnotic

Experimental: BBT-I first group
received two-week brief behavioral therapy followed by medication therapy (zopiclone).
Behavioral: Brief behavioral therapy
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.
Other Name: BBT-I

Drug: Zopiclone
zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
Other Name: hypnotic




Primary Outcome Measures :
  1. Insomnia Severity Index [ Time Frame: 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).


Secondary Outcome Measures :
  1. Beck Depression Inventory [ Time Frame: 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) ]
    21-item questionnaire assessing (on 4-point Likert scales) the intensity of depressive symptoms in the past week. Minimum score 0, maximum score 63 points. Higher total score represents more severe depressive symptoms

  2. State Anxiety Subscale (STAI) [ Time Frame: 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 trait anxiety scale is a 2-part questionnaire assessing state (situational) and trait anxiety. State anxiety subscale comprise 20 items rated on a 4-point Likert scale. Minimum score for subscale is 20 and maximum score is 80 points. Higher total score indicates more severe anxiety symptoms

  3. Dysfunctional Beliefs About Sleep Scale [ Time Frame: 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) ]
    questionnaire assessing sleep related cognitions in 16 item rated on a 10-point Likert scale. Minimum score is 0, maximum score is 160 points. Higher total score represents more intensive disfunctional beliefs

  4. Sleep Hygiene Index [ Time Frame: 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) ]
    questionnaire assessing sleep related behavior in 13 item rated on a 5-point Likert scale.Minimum score 13 points and maximum score 65 points. Higher total score represents worse sleep hygiene

  5. Pittsburgh Sleep Quality Index [ Time Frame: 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) ]
    19-item questionnaire evaluating sleep quality over the past month. The first 4 items are open questions, items 5 to 19 are rated on a 4-point Likert scale. A total score range from 0 to 21. A score > 5 suggests poor sleep quality.

  6. Trait Anxiety Subscale (STAI) [ Time Frame: 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) ]
    STAI is a 2-part questionnaire assessing state (situational) and trait anxiety. Trait anxiety subscale comprise 20 items rated on a 4-point Likert scale. Minimum score for each subscale is 20 and maximum score is 80 points. Higher total score indicates more severe anxiety symptoms


Other Outcome Measures:
  1. Toronto Alexithymia Scale (TAS-20) [ Time Frame: once at baseline assessment ]
    Degree of alexithymia evaluated by Toronto Alexithymia scale (20 questions) Measure Description: 0-100 scores. higher values represent worse outcome

  2. Sleep Latency [ Time Frame: once at baseline assessment ]
    time period from bedding to sleep onset

  3. Total Sleep Time [ Time Frame: once at baseline assessment ]
    total sleep episode minus wake time

  4. Sleep Efficiency [ Time Frame: once at baseline assessment ]
    Prercentage of Total Bed Time

  5. Wake After Sleep Onset [ Time Frame: once at baseline assessment ]
    total duration of all periods of wakefulness between sleep onset and final awakening in the morning

  6. Amount of Awakenings [ Time Frame: once at baseline assessment ]
    Number of awakenings between sleep onset and final morning awakening

  7. N1 NREM Sleep Percentage [ Time Frame: once at baseline assessment ]
    Percentage of Total Sleep Time

  8. N2 NREM Sleep Percentage [ Time Frame: once at baseline assessment ]
    Percentage of Total Sleep Time

  9. N3 NREM Sleep Percentage [ Time Frame: once at baseline assessment ]
    Percentage of Total Sleep Time

  10. REM Sleep Percentage [ Time Frame: once at baseline assessment ]
    Percentage of Total Sleep Time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339583


Sponsors and Collaborators
I.M. Sechenov First Moscow State Medical University
Investigators
Layout table for investigator information
Principal Investigator: Polina Pchelina, PG student I.M. Sechenov First Moscow State Medical University
  Study Documents (Full-Text)

Documents provided by Polina Pchelina, I.M. Sechenov First Moscow State Medical University:
Informed Consent Form  [PDF] March 18, 2015

Publications of Results:
Layout table for additonal information
Responsible Party: 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
ClinicalTrials.gov Identifier: NCT03339583    
Other Study ID Numbers: 1
First Posted: November 13, 2017    Key Record Dates
Results First Posted: June 17, 2019
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Since our lab has no plans to continue or extend the registered study we are not planning share individual patient data with other researches

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Polina Pchelina, I.M. Sechenov First Moscow State Medical University:
chronic insomnia
brief behavioral treatment
behavioral treatment
insomnia severity index
predictors
treatment response
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Zopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs