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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zopiclone first group | Experimental | underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy |
|
| BBT-I first group | Experimental | received two-week brief behavioral therapy followed by medication therapy (zopiclone). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief behavioral therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | 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). | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Alexithymia Scale (TAS-20) | Degree of alexithymia evaluated by Toronto Alexithymia scale (20 questions) Measure Description: 0-100 scores. higher values represent worse outcome | once at baseline assessment |
| Sleep Latency |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Polina Pchelina, PG student | I.M. Sechenov First Moscow State Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28777364 | Result | Pchelina PV, Tabidze AA, Poluektov MG. [Comparative study of effectiveness of cognitive-behavior therapy and zopiclone for chronic insomnia]. Zh Nevrol Psikhiatr Im S S Korsakova. 2017;117(4. Vyp. 2):48-55. doi: 10.17116/jnevro20171174248-55. Russian. |
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Since our lab has no plans to continue or extend the registered study we are not planning share individual patient data with other researches
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (14 Days) |
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| Washout (14 Days) |
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| Second Intervention (14 Days) |
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| Follow-up (14 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zopiclone First Group | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insomnia Severity Index | 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). | 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 | Posted | Mean | Standard Deviation | units on a scale | 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) |
|
2 months
Adverse effects were evaluated systematically during biweekly visits
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BBT-I | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash hypersensitivity reaction to zopiclone | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Polina Pchelina | I.M. Sechenov First Moscow State Medical University | +79036701725 | polbox@mail.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2015 | Nov 9, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2015 | Nov 9, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C515050 | zopiclone |
| D006993 | Hypnotics and Sedatives |
| ID | Term |
|---|---|
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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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.
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|
|
| Zopiclone | Drug | zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks |
|
|
| State Anxiety Subscale (STAI) | 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 | 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) |
| Dysfunctional Beliefs About Sleep Scale | 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 | 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) |
| Sleep Hygiene Index | 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 | 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) |
| Pittsburgh Sleep Quality Index | 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. | 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) |
| Trait Anxiety Subscale (STAI) | 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 | 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) |
time period from bedding to sleep onset
| once at baseline assessment |
| Total Sleep Time | total sleep episode minus wake time | once at baseline assessment |
| Sleep Efficiency | Prercentage of Total Bed Time | once at baseline assessment |
| Wake After Sleep Onset | total duration of all periods of wakefulness between sleep onset and final awakening in the morning | once at baseline assessment |
| Amount of Awakenings | Number of awakenings between sleep onset and final morning awakening | once at baseline assessment |
| N1 NREM Sleep Percentage | Percentage of Total Sleep Time | once at baseline assessment |
| N2 NREM Sleep Percentage | Percentage of Total Sleep Time | once at baseline assessment |
| N3 NREM Sleep Percentage | Percentage of Total Sleep Time | once at baseline assessment |
| REM Sleep Percentage | Percentage of Total Sleep Time | once at baseline assessment |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | BBT-I First Group | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Beck depression inventory | 0-63 scores. higher values represent worse outcome | Mean | Standard Deviation | units on a scale |
|
| State anxiety inventory | 0-80 scores. higher values represent worse outcome | Mean | Standard Deviation | units on a scale |
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| trait anxiety inventory | 0-80 scores. higher values represent worse outcome | Mean | Standard Deviation | units on a scale |
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| Dysfunctional beliefs about sleep scale | Measure Description: 0-160 scores. higher values represent worse outcome | Mean | Standard Deviation | units on a scale |
|
| Sleep hygiene index | Measure Description: 0-65 scores. higher values represent worse outcome | Mean | Standard Deviation | units on a scale |
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| Insomnia severity index | 0-28 scores. higher values represent worse outcome | Mean | Standard Deviation | units on a scale |
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| Pittsburgh sleep quality index | Measure Description: 0-24 scores. higher values represent worse outcome | Mean | Standard Deviation | units on a scale |
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| Toronto Alexithymia scale-20 | Measure Description: 0-100 scores. higher values represent worse outcome | Mean | Standard Deviation | units on a scale |
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| Sleep efficiency | derived from 1-night polysomnography at baseline | Mean | Standard Deviation | percentage of polysomnogram time |
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| sleep latency | derived from 1-night polysomnography | Mean | Standard Deviation | minutes |
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| Wake after sleep onset | derived from 1-night polysomnography | Mean | Standard Deviation | minutes |
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| Awakenings | derived from 1-night polysomnography | Mean | Standard Deviation | awakenings |
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| N1 NREM sleep percentage | derived from 1-night polysomnography | Mean | Standard Deviation | percentage of time |
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| N2 NREM sleep percentage | derived from 1-night polysomnography | Mean | Standard Deviation | percentage of time |
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| N3 NREM sleep percentage | derived from 1-night polysomnography | Mean | Standard Deviation | percentage of time |
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| REM sleep percentage | derived from 1-night polysomnography | Mean | Standard Deviation | percentage of time |
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| Total sleep time | derived from 1-night polysomnography | Mean | Standard Deviation | hours |
|
| OG001 | Zopiclone First Group | 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 |
|
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| Secondary | Beck Depression Inventory | 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 | 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 | Posted | Mean | Standard Deviation | units on a 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) |
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| Secondary | State Anxiety Subscale (STAI) | 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 | 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 | Posted | Mean | Standard Deviation | units on a 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) |
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| Secondary | Dysfunctional Beliefs About Sleep Scale | 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 | 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 | Posted | Mean | Standard Deviation | units on a 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) |
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| Secondary | Sleep Hygiene Index | 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 | 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 | Posted | Mean | Standard Deviation | units on a 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) |
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| Secondary | Pittsburgh Sleep Quality Index | 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. | 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 | Posted | Mean | Standard Deviation | units on a 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) |
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| Secondary | Trait Anxiety Subscale (STAI) | 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 | 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 | Posted | Mean | Standard Deviation | units on a 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) |
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| Other Pre-specified | Toronto Alexithymia Scale (TAS-20) | Degree of alexithymia evaluated by Toronto Alexithymia scale (20 questions) Measure Description: 0-100 scores. higher values represent worse outcome | All randomised participants who filled baseline set of questionnaires | Posted | Mean | Standard Deviation | scores on a scale | once at baseline assessment |
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| Other Pre-specified | Sleep Latency | time period from bedding to sleep onset | 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 | Posted | Mean | Standard Deviation | minutes | once at baseline assessment |
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| Other Pre-specified | Total Sleep Time | total sleep episode minus wake time | Analysis included all randomized participants | Posted | Mean | Standard Deviation | hours | once at baseline assessment |
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| Other Pre-specified | Sleep Efficiency | Prercentage of Total Bed Time | Analysis included all participants who were randomized and filled set of questionnaires at baseline assessment | Posted | Mean | Standard Deviation | percentage of polysomnogram time | once at baseline assessment |
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| Other Pre-specified | Wake After Sleep Onset | total duration of all periods of wakefulness between sleep onset and final awakening in the morning | All randomised participants who filled baseline set of questionnaires | Posted | Mean | Standard Deviation | minutes | once at baseline assessment |
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| Other Pre-specified | Amount of Awakenings | Number of awakenings between sleep onset and final morning awakening | All randomised participants who filled baseline set of questionnaires | Posted | Mean | Standard Deviation | awakenings | once at baseline assessment |
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| Other Pre-specified | N1 NREM Sleep Percentage | Percentage of Total Sleep Time | All randomised participants who filled baseline set of questionnaires | Posted | Mean | Standard Deviation | percentage of total sleep time | once at baseline assessment |
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| Other Pre-specified | N2 NREM Sleep Percentage | Percentage of Total Sleep Time | All randomised participants who filled baseline set of questionnaires | Posted | Mean | Standard Deviation | percentage of time | once at baseline assessment |
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| Other Pre-specified | N3 NREM Sleep Percentage | Percentage of Total Sleep Time | All randomised participants who filled baseline set of questionnaires | Posted | Mean | Standard Deviation | percentage of total sleep time | once at baseline assessment |
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| Other Pre-specified | REM Sleep Percentage | Percentage of Total Sleep Time | All randomised participants who filled baseline set of questionnaires | Posted | Mean | Standard Deviation | percentage of total sleep time | once at baseline assessment |
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Zopiclone | Zopiclone: zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks | 0 | 41 | 0 | 41 | 2 | 41 |
| bitter taste | Hepatobiliary disorders | Non-systematic Assessment |
|
Not provided
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| D001523 |
| Mental Disorders |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| first treatment course |
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| After washout |
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| Second treatment course |
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| After follow-up |
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| First treatment course |
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| After follow-up |
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| After follow-up |
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| After follow-up |
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| First treatment course |
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| After follow-up |
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