Trial Outcomes & Findings for Effectiveness of BBT-I and Zopiclone for Chronic Insomnia (NCT NCT03339583)

Last Updated: 2019-09-16

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

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)

Results posted on

2019-09-16

Participant Flow

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

Participant milestones

Participant milestones
Measure	Zopiclone First, Then BBT-I 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	BBT-I First, Then Zopiclone 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
First Intervention (14 Days) STARTED	19	23
First Intervention (14 Days) COMPLETED	18	23
First Intervention (14 Days) NOT COMPLETED	1	0
Washout (14 Days) STARTED	18	23
Washout (14 Days) COMPLETED	18	23
Washout (14 Days) NOT COMPLETED	0	0
Second Intervention (14 Days) STARTED	18	23
Second Intervention (14 Days) COMPLETED	18	21
Second Intervention (14 Days) NOT COMPLETED	0	2
Follow-up (14 Days) STARTED	18	21
Follow-up (14 Days) COMPLETED	12	18
Follow-up (14 Days) NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Zopiclone First, Then BBT-I 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	BBT-I First, Then Zopiclone 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
First Intervention (14 Days) Adverse Event	1	0
Second Intervention (14 Days) unrelated acute exacerbation	0	1
Second Intervention (14 Days) Adverse Event	0	1
Follow-up (14 Days) Physician Decision	6	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zopiclone First Group n=19 Participants 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	BBT-I First Group n=23 Participants 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 n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=19 Participants	0 Participants n=23 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=19 Participants	20 Participants n=23 Participants	33 Participants n=42 Participants
Age, Categorical >=65 years	6 Participants n=19 Participants	3 Participants n=23 Participants	9 Participants n=42 Participants
Age, Continuous	55.0 years STANDARD_DEVIATION 14.8 • n=19 Participants	47.5 years STANDARD_DEVIATION 14.1 • n=23 Participants	50.7 years STANDARD_DEVIATION 14.5 • n=42 Participants
Sex: Female, Male Female	11 Participants n=19 Participants	16 Participants n=23 Participants	27 Participants n=42 Participants
Sex: Female, Male Male	8 Participants n=19 Participants	7 Participants n=23 Participants	15 Participants n=42 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Russia	19 Participants n=19 Participants	23 Participants n=23 Participants	42 Participants n=42 Participants
Beck depression inventory	10.8 units on a scale STANDARD_DEVIATION 5.0 • n=19 Participants	12.8 units on a scale STANDARD_DEVIATION 7.2 • n=23 Participants	12.1 units on a scale STANDARD_DEVIATION 6.1 • n=42 Participants
State anxiety inventory	43.5 units on a scale STANDARD_DEVIATION 8.7 • n=19 Participants	46.9 units on a scale STANDARD_DEVIATION 6.9 • n=23 Participants	45.3 units on a scale STANDARD_DEVIATION 8.1 • n=42 Participants
trait anxiety inventory	49.6 units on a scale STANDARD_DEVIATION 8.3 • n=19 Participants	49.1 units on a scale STANDARD_DEVIATION 7.2 • n=23 Participants	49.3 units on a scale STANDARD_DEVIATION 7.5 • n=42 Participants
Dysfunctional beliefs about sleep scale	105.3 units on a scale STANDARD_DEVIATION 28.7 • n=19 Participants	104.9 units on a scale STANDARD_DEVIATION 30.2 • n=23 Participants	105.1 units on a scale STANDARD_DEVIATION 27.2 • n=42 Participants
Sleep hygiene index	26.7 units on a scale STANDARD_DEVIATION 6.3 • n=19 Participants	28.7 units on a scale STANDARD_DEVIATION 7.3 • n=23 Participants	27.9 units on a scale STANDARD_DEVIATION 6.1 • n=42 Participants
Insomnia severity index	18.7 units on a scale STANDARD_DEVIATION 4.1 • n=19 Participants	17.5 units on a scale STANDARD_DEVIATION 5.4 • n=23 Participants	18.6 units on a scale STANDARD_DEVIATION 4.6 • n=42 Participants
Pittsburgh sleep quality index	13.3 units on a scale STANDARD_DEVIATION 3.5 • n=19 Participants	14.5 units on a scale STANDARD_DEVIATION 2.7 • n=23 Participants	14.0 units on a scale STANDARD_DEVIATION 3.1 • n=42 Participants
Toronto Alexithymia scale-20	49.8 units on a scale STANDARD_DEVIATION 15.9 • n=19 Participants	49.3 units on a scale STANDARD_DEVIATION 10.0 • n=23 Participants	49.5 units on a scale STANDARD_DEVIATION 12.9 • n=42 Participants
Sleep efficiency	64.68 percentage of polysomnogram time STANDARD_DEVIATION 17.9 • n=19 Participants	63.3 percentage of polysomnogram time STANDARD_DEVIATION 18.0 • n=23 Participants	63.9 percentage of polysomnogram time STANDARD_DEVIATION 17.7 • n=42 Participants
sleep latency	38.5 minutes STANDARD_DEVIATION 21.7 • n=19 Participants	54.5 minutes STANDARD_DEVIATION 51.0 • n=23 Participants	47.0 minutes STANDARD_DEVIATION 40.2 • n=42 Participants
Wake after sleep onset	102.4 minutes STANDARD_DEVIATION 69.0 • n=19 Participants	104.8 minutes STANDARD_DEVIATION 76.1 • n=23 Participants	103.6 minutes STANDARD_DEVIATION 71.9 • n=42 Participants
Awakenings	13.8 awakenings STANDARD_DEVIATION 6.1 • n=19 Participants	13.3 awakenings STANDARD_DEVIATION 6.9 • n=23 Participants	13.5 awakenings STANDARD_DEVIATION 6.5 • n=42 Participants
N1 NREM sleep percentage	4.2 percentage of time STANDARD_DEVIATION 3.1 • n=19 Participants	3.7 percentage of time STANDARD_DEVIATION 3.3 • n=23 Participants	3.9 percentage of time STANDARD_DEVIATION 3.2 • n=42 Participants
N2 NREM sleep percentage	64.2 percentage of time STANDARD_DEVIATION 10.2 • n=19 Participants	62.6 percentage of time STANDARD_DEVIATION 8.4 • n=23 Participants	63.3 percentage of time STANDARD_DEVIATION 9.2 • n=42 Participants
N3 NREM sleep percentage	17.5 percentage of time STANDARD_DEVIATION 8.8 • n=19 Participants	16.4 percentage of time STANDARD_DEVIATION 7.0 • n=23 Participants	16.9 percentage of time STANDARD_DEVIATION 7.8 • n=42 Participants
REM sleep percentage	14.1 percentage of time STANDARD_DEVIATION 5.5 • n=19 Participants	17.0 percentage of time STANDARD_DEVIATION 7.7 • n=23 Participants	15.6 percentage of time STANDARD_DEVIATION 6.8 • n=42 Participants
Total sleep time	5.7 hours STANDARD_DEVIATION 1.6 • n=19 Participants	5.5 hours STANDARD_DEVIATION 1.6 • n=23 Participants	5.6 hours STANDARD_DEVIATION 1.6 • n=42 Participants

PRIMARY outcome

Timeframe: 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)

Population: 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

Outcome measures

Outcome measures
Measure	BBT-I First Group n=23 Participants 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	Zopiclone First Group n=19 Participants 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
Insomnia Severity Index Baseline/initial examination	18.6 units on a scale Standard Deviation 5.2	18.9 units on a scale Standard Deviation 3.9
Insomnia Severity Index First treatment course	13.1 units on a scale Standard Deviation 5.2	14.0 units on a scale Standard Deviation 5.7
Insomnia Severity Index After washout	14.3 units on a scale Standard Deviation 6.3	16.1 units on a scale Standard Deviation 4.7
Insomnia Severity Index Second treatment course	12.1 units on a scale Standard Deviation 6.1	12.8 units on a scale Standard Deviation 5.4
Insomnia Severity Index After follow-up	13.1 units on a scale Standard Deviation 4.7	12.7 units on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	BBT-I First Group n=23 Participants 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	Zopiclone First Group n=19 Participants 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
Beck Depression Inventory Baseline/initial examination	11.5 units on a scale Standard Deviation 6.8	9.3 units on a scale Standard Deviation 7.3
Beck Depression Inventory first treatment course	8.4 units on a scale Standard Deviation 6.8	9.4 units on a scale Standard Deviation 8.2
Beck Depression Inventory After washout	8.4 units on a scale Standard Deviation 8.2	9.8 units on a scale Standard Deviation 5.1
Beck Depression Inventory Second treatment course	9.2 units on a scale Standard Deviation 9.0	8.5 units on a scale Standard Deviation 6.2
Beck Depression Inventory After follow-up	9.0 units on a scale Standard Deviation 8.1	7.4 units on a scale Standard Deviation 6.2

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	BBT-I First Group n=23 Participants 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	Zopiclone First Group n=19 Participants 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
State Anxiety Subscale (STAI) Baseline/initial examination	45.1 units on a scale Standard Deviation 8.8	43.2 units on a scale Standard Deviation 8.5
State Anxiety Subscale (STAI) First treatment course	43.8 units on a scale Standard Deviation 8.6	44.3 units on a scale Standard Deviation 9.1
State Anxiety Subscale (STAI) After washout	45.5 units on a scale Standard Deviation 9.0	44.5 units on a scale Standard Deviation 9.8
State Anxiety Subscale (STAI) Second treatment course	45.1 units on a scale Standard Deviation 9.1	44.0 units on a scale Standard Deviation 9.6
State Anxiety Subscale (STAI) After follow-up	46.9 units on a scale Standard Deviation 6.5	44.2 units on a scale Standard Deviation 10.4

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	BBT-I First Group n=23 Participants 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	Zopiclone First Group n=19 Participants 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
Dysfunctional Beliefs About Sleep Scale After washout	84.76 units on a scale Standard Deviation 36.9	103.6 units on a scale Standard Deviation 32.2
Dysfunctional Beliefs About Sleep Scale Second treatment course	84.5 units on a scale Standard Deviation 39.8	89.2 units on a scale Standard Deviation 35.4
Dysfunctional Beliefs About Sleep Scale Baseline/initial examination	105.2 units on a scale Standard Deviation 29.0	93.2 units on a scale Standard Deviation 35.0
Dysfunctional Beliefs About Sleep Scale First treatment course	83.8 units on a scale Standard Deviation 34.8	96.4 units on a scale Standard Deviation 36.4
Dysfunctional Beliefs About Sleep Scale After follow-up	62.8 units on a scale Standard Deviation 34.5	92.0 units on a scale Standard Deviation 34.5

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	BBT-I First Group n=23 Participants 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	Zopiclone First Group n=19 Participants 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
Sleep Hygiene Index Baseline/initial examination	26.8 units on a scale Standard Deviation 7.4	25.2 units on a scale Standard Deviation 5.9
Sleep Hygiene Index First treatment course	24.0 units on a scale Standard Deviation 5.6	25.0 units on a scale Standard Deviation 6.9
Sleep Hygiene Index After washout	24.7 units on a scale Standard Deviation 6.0	25.5 units on a scale Standard Deviation 7.4
Sleep Hygiene Index Second treatment course	24.7 units on a scale Standard Deviation 6.6	24.3 units on a scale Standard Deviation 6.6
Sleep Hygiene Index After follow-up	23.8 units on a scale Standard Deviation 6.5	25.2 units on a scale Standard Deviation 7.6

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	BBT-I First Group n=23 Participants 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	Zopiclone First Group n=19 Participants 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
Pittsburgh Sleep Quality Index Baseline/initial examination	13.4 units on a scale Standard Deviation 3.6	11.9 units on a scale Standard Deviation 4.1
Pittsburgh Sleep Quality Index First treatment course	10.5 units on a scale Standard Deviation 4.5	11.3 units on a scale Standard Deviation 4.1
Pittsburgh Sleep Quality Index After washout	11.3 units on a scale Standard Deviation 4.4	12.7 units on a scale Standard Deviation 3.8
Pittsburgh Sleep Quality Index Second treatment course	10.8 units on a scale Standard Deviation 4.4	11.7 units on a scale Standard Deviation 4.8
Pittsburgh Sleep Quality Index After follow-up	11.2 units on a scale Standard Deviation 4.9	11.1 units on a scale Standard Deviation 4.7

SECONDARY outcome

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