Effectiveness of BBT-I and Zopiclone for Chronic Insomnia

• Sponsor: I.M. Sechenov First Moscow State Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03339583
• Collaborator: (none)
• Enrollment: 42
• Arms: 2
• Actual Duration (Months): 23.2

Study Details

Study Description

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

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.

Study Design

• Study Type: Interventional
• 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.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: Apr 7, 2015
• Actual Primary Completion Date: Mar 14, 2017
• Actual Study Completion Date: Mar 14, 2017

Arms and Interventions

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 Names: BBT-I ; Drug: Zopiclone; zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks; Other Names: 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 Names: BBT-I ; Drug: Zopiclone; zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks; Other Names: hypnotic

Outcome Measures

Primary Outcome Measures

1. Insomnia Severity Index [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 [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) [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 [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 [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 [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) [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) [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 [once at baseline assessment]

   time period from bedding to sleep onset

3. Total Sleep Time [once at baseline assessment]

   total sleep episode minus wake time

4. Sleep Efficiency [once at baseline assessment]

   Prercentage of Total Bed Time

5. Wake After Sleep Onset [once at baseline assessment]

   total duration of all periods of wakefulness between sleep onset and final awakening in the morning

6. Amount of Awakenings [once at baseline assessment]

   Number of awakenings between sleep onset and final morning awakening

7. N1 NREM Sleep Percentage [once at baseline assessment]

   Percentage of Total Sleep Time

8. N2 NREM Sleep Percentage [once at baseline assessment]

   Percentage of Total Sleep Time

9. N3 NREM Sleep Percentage [once at baseline assessment]

   Percentage of Total Sleep Time

10. REM Sleep Percentage [once at baseline assessment]

    Percentage of Total Sleep Time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• I.M. Sechenov First Moscow State Medical University

Investigators

• Principal Investigator: Polina Pchelina, PG student, I.M. Sechenov First Moscow State Medical University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 18, 2015
• Informed Consent Form - Mar 18, 2015

More Information

Publications

None provided.

• 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: Nov 13, 2017
• Last Update Posted: Sep 16, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by 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: chronic insomnia; brief behavioral treatment; behavioral treatment; insomnia severity index; predictors; treatment response
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Zopiclone

Study Results

Participant Flow

Pre-assignment Detail	The decision to recruit more patients than it was stated in protocol was made because of dropout of 3 patients and in order to get enough experimental data to provide statistical power

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Period Title: First Intervention (14 Days)
STARTED	19	23
COMPLETED	18	23
NOT COMPLETED	1	0
Period Title: First Intervention (14 Days)
STARTED	18	23
COMPLETED	18	23
NOT COMPLETED	0	0
Period Title: First Intervention (14 Days)
STARTED	18	23
COMPLETED	18	21
NOT COMPLETED	0	2
Period Title: First Intervention (14 Days)
STARTED	18	21
COMPLETED	12	18
NOT COMPLETED	6	3

Baseline Characteristics

Arm/Group Title	Zopiclone First Group	BBT-I First Group	Total
Arm/Group Description	underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks	received two-week brief behavioral therapy followed by medication therapy (zopiclone). 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks	Total of all reporting groups
Overall Participants	19	23	42
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 68.4%	20 87%	33 78.6%
>=65 years	6 31.6%	3 13%	9 21.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.0 (14.8)	47.5 (14.1)	50.7 (14.5)
Sex: Female, Male (Count of Participants)
Female	11 57.9%	16 69.6%	27 64.3%
Male	8 42.1%	7 30.4%	15 35.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Russia	19 100%	23 100%	42 100%
Beck depression inventory (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	10.8 (5.0)	12.8 (7.2)	12.1 (6.1)
State anxiety inventory (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	43.5 (8.7)	46.9 (6.9)	45.3 (8.1)
trait anxiety inventory (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	49.6 (8.3)	49.1 (7.2)	49.3 (7.5)
Dysfunctional beliefs about sleep scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	105.3 (28.7)	104.9 (30.2)	105.1 (27.2)
Sleep hygiene index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	26.7 (6.3)	28.7 (7.3)	27.9 (6.1)
Insomnia severity index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.7 (4.1)	17.5 (5.4)	18.6 (4.6)
Pittsburgh sleep quality index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	13.3 (3.5)	14.5 (2.7)	14.0 (3.1)
Toronto Alexithymia scale-20 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	49.8 (15.9)	49.3 (10.0)	49.5 (12.9)
Sleep efficiency (percentage of polysomnogram time) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of polysomnogram time]	64.68 (17.9)	63.3 (18.0)	63.9 (17.7)
sleep latency (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	38.5 (21.7)	54.5 (51.0)	47.0 (40.2)
Wake after sleep onset (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	102.4 (69.0)	104.8 (76.1)	103.6 (71.9)
Awakenings (awakenings) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [awakenings]	13.8 (6.1)	13.3 (6.9)	13.5 (6.5)
N1 NREM sleep percentage (percentage of time) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of time]	4.2 (3.1)	3.7 (3.3)	3.9 (3.2)
N2 NREM sleep percentage (percentage of time) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of time]	64.2 (10.2)	62.6 (8.4)	63.3 (9.2)
N3 NREM sleep percentage (percentage of time) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of time]	17.5 (8.8)	16.4 (7.0)	16.9 (7.8)
REM sleep percentage (percentage of time) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of time]	14.1 (5.5)	17.0 (7.7)	15.6 (6.8)
Total sleep time (hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours]	5.7 (1.6)	5.5 (1.6)	5.6 (1.6)

Outcome Measures

1. Primary Outcome

Title	Insomnia Severity Index
Description	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).
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)

Outcome Measure Data

Analysis Population Description

Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect

Arm/Group Title	BBT-I First Group	Zopiclone First Group
Arm/Group Description	received two-week brief behavioral therapy followed by medication therapy (zopiclone). 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks	underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
Measure Participants	23	19
Baseline/initial examination	18.6 (5.2)	18.9 (3.9)
First treatment course	13.1 (5.2)	14.0 (5.7)
After washout	14.3 (6.3)	16.1 (4.7)
Second treatment course	12.1 (6.1)	12.8 (5.4)
After follow-up	13.1 (4.7)	12.7 (5.9)

2. Secondary Outcome

Title	Beck Depression Inventory
Description	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
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)

Outcome Measure Data

Analysis Population Description

Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect

Arm/Group Title	BBT-I First Group	Zopiclone First Group
Arm/Group Description	received two-week brief behavioral therapy followed by medication therapy (zopiclone). 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks	underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
Measure Participants	23	19
Baseline/initial examination	11.5 (6.8)	9.3 (7.3)
first treatment course	8.4 (6.8)	9.4 (8.2)
After washout	8.4 (8.2)	9.8 (5.1)
Second treatment course	9.2 (9.0)	8.5 (6.2)
After follow-up	9.0 (8.1)	7.4 (6.2)

3. Secondary Outcome

Title	State Anxiety Subscale (STAI)
Description	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
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)

Outcome Measure Data

Analysis Population Description

Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect

Arm/Group Title	BBT-I First Group	Zopiclone First Group
Arm/Group Description	received two-week brief behavioral therapy followed by medication therapy (zopiclone). 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks	underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
Measure Participants	23	19
Baseline/initial examination	45.1 (8.8)	43.2 (8.5)
First treatment course	43.8 (8.6)	44.3 (9.1)
After washout	45.5 (9.0)	44.5 (9.8)
Second treatment course	45.1 (9.1)	44.0 (9.6)
After follow-up	46.9 (6.5)	44.2 (10.4)

4. Secondary Outcome

Title	Dysfunctional Beliefs About Sleep Scale
Description	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
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)

Outcome Measure Data

Analysis Population Description

Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect

Arm/Group Title	BBT-I First Group	Zopiclone First Group
Arm/Group Description	received two-week brief behavioral therapy followed by medication therapy (zopiclone). 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks	underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
Measure Participants	23	19
Baseline/initial examination	105.2 (29.0)	93.2 (35.0)
First treatment course	83.8 (34.8)	96.4 (36.4)
After washout	84.76 (36.9)	103.6 (32.2)
Second treatment course	84.5 (39.8)	89.2 (35.4)
After follow-up	62.8 (34.5)	92.0 (34.5)

5. Secondary Outcome

Title	Sleep Hygiene Index
Description	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
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)

Outcome Measure Data

Analysis Population Description

Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect

Arm/Group Title	BBT-I First Group	Zopiclone First Group
Arm/Group Description	received two-week brief behavioral therapy followed by medication therapy (zopiclone). 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks	underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
Measure Participants	23	19
Baseline/initial examination	26.8 (7.4)	25.2 (5.9)
First treatment course	24.0 (5.6)	25.0 (6.9)
After washout	24.7 (6.0)	25.5 (7.4)
Second treatment course	24.7 (6.6)	24.3 (6.6)
After follow-up	23.8 (6.5)	25.2 (7.6)

6. Secondary Outcome

Title	Pittsburgh Sleep Quality Index
Description	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.
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)

Outcome Measure Data

Analysis Population Description

Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect

Arm/Group Title	BBT-I First Group	Zopiclone First Group
Arm/Group Description	received two-week brief behavioral therapy followed by medication therapy (zopiclone). 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks	underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
Measure Participants	23	19
Baseline/initial examination	13.4 (3.6)	11.9 (4.1)
First treatment course	10.5 (4.5)	11.3 (4.1)
After washout	11.3 (4.4)	12.7 (3.8)
Second treatment course	10.8 (4.4)	11.7 (4.8)
After follow-up	11.2 (4.9)	11.1 (4.7)

7. Secondary Outcome

Title	Trait Anxiety Subscale (STAI)
Description	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
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)

Outcome Measure Data

Analysis Population Description

Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect

Arm/Group Title	BBT-I First Group	Zopiclone First Group
Arm/Group Description	received two-week brief behavioral therapy followed by medication therapy (zopiclone). 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks	underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy 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. Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
Measure Participants	23	19
Baseline/initial examination	48.7 (6.9)	48.3 (8.1)
First treatment course	48.3 (8.1)	48.3 (8.6)
After washout	48.6 (7.6)	49.3 (7.0)
Second treatment course	46.3 (9.5)	48.5 (8.3)
After follow-up	46.3 (8.6)	48.8 (10.7)

8. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

All randomised participants who filled baseline set of questionnaires

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Measure Participants	19	23
Mean (Standard Deviation) [scores on a scale]	49.83 (15.9)	49.33 (10.0)

9. Other Pre-specified Outcome

Title	Sleep Latency
Description	time period from bedding to sleep onset
Time Frame	once at baseline assessment

Outcome Measure Data

Analysis Population Description

Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Measure Participants	19	23
Mean (Standard Deviation) [minutes]	38.53 (21.7)	54.5 (51.0)

10. Other Pre-specified Outcome

Title	Total Sleep Time
Description	total sleep episode minus wake time
Time Frame	once at baseline assessment

Outcome Measure Data

Analysis Population Description

Analysis included all randomized participants

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Measure Participants	19	23
Mean (Standard Deviation) [hours]	5.72 (1.6)	5.51 (1.6)

11. Other Pre-specified Outcome

Title	Sleep Efficiency
Description	Prercentage of Total Bed Time
Time Frame	once at baseline assessment

Outcome Measure Data

Analysis Population Description

Analysis included all participants who were randomized and filled set of questionnaires at baseline assessment

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Measure Participants	19	23
Mean (Standard Deviation) [percentage of polysomnogram time]	64.68 (17.9)	63.29 (18.0)

12. Other Pre-specified Outcome

Title	Wake After Sleep Onset
Description	total duration of all periods of wakefulness between sleep onset and final awakening in the morning
Time Frame	once at baseline assessment

Outcome Measure Data

Analysis Population Description

All randomised participants who filled baseline set of questionnaires

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Measure Participants	19	23
Mean (Standard Deviation) [minutes]	102.39 (69.0)	104.75 (76.1)

13. Other Pre-specified Outcome

Title	Amount of Awakenings
Description	Number of awakenings between sleep onset and final morning awakening
Time Frame	once at baseline assessment

Outcome Measure Data

Analysis Population Description

All randomised participants who filled baseline set of questionnaires

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Measure Participants	19	23
Mean (Standard Deviation) [awakenings]	13.78 (6.1)	13.25 (6.9)

14. Other Pre-specified Outcome

Title	N1 NREM Sleep Percentage
Description	Percentage of Total Sleep Time
Time Frame	once at baseline assessment

Outcome Measure Data

Analysis Population Description

All randomised participants who filled baseline set of questionnaires

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Measure Participants	19	23
Mean (Standard Deviation) [percentage of total sleep time]	4.16 (3.1)	3.70 (3.3)

15. Other Pre-specified Outcome

Title	N2 NREM Sleep Percentage
Description	Percentage of Total Sleep Time
Time Frame	once at baseline assessment

Outcome Measure Data

Analysis Population Description

All randomised participants who filled baseline set of questionnaires

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Measure Participants	19	23
Mean (Standard Deviation) [percentage of time]	64.19 (10.2)	62.58 (8.4)

16. Other Pre-specified Outcome

Title	N3 NREM Sleep Percentage
Description	Percentage of Total Sleep Time
Time Frame	once at baseline assessment

Outcome Measure Data

Analysis Population Description

All randomised participants who filled baseline set of questionnaires

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Measure Participants	19	23
Mean (Standard Deviation) [percentage of total sleep time]	17.52 (8.8)	16.39 (7.0)

17. Other Pre-specified Outcome

Title	REM Sleep Percentage
Description	Percentage of Total Sleep Time
Time Frame	once at baseline assessment

Outcome Measure Data

Analysis Population Description

All randomised participants who filled baseline set of questionnaires

Arm/Group Title	Zopiclone First, Then BBT-I	BBT-I First, Then Zopiclone
Arm/Group Description	Participants first received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. After a washout of two weeks they then received Brief behavioral therapy program for two weeks in two weekly individual sessions. Then they completed follow-up for two weeks	Participants first received Brief behavioral therapy program for two weeks in two weekly individual sessions. After a washout of two weeks they then received zopiclone in a dose of 7.5 mg 30 minutes before bedtime for two weeks. Then they completed follow-up for two weeks
Measure Participants	19	23
Mean (Standard Deviation) [percentage of total sleep time]	14.1 (5.5)	17.0 (7.7)

Adverse Events

Time Frame	2 months
Adverse Event Reporting Description	Adverse effects were evaluated systematically during biweekly visits
Arm/Group Title	BBT-I		Zopiclone
Arm/Group Description	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.		Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
All Cause Mortality
	BBT-I		Zopiclone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/41 (0%)
Serious Adverse Events
	BBT-I		Zopiclone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	BBT-I		Zopiclone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		2/41 (4.9%)
Hepatobiliary disorders
bitter taste	0/42 (0%)	0	1/41 (2.4%)	2
Skin and subcutaneous tissue disorders
rash hypersensitivity reaction to zopiclone	0/42 (0%)	0	1/41 (2.4%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.