Effectiveness of BBT-I and Zopiclone for Chronic Insomnia

NCT03339583 | Completed Phase 2 Results

• 1 other identifier: 1
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Conditions

Insomnia Chronic

Keywords

chronic insomnia; brief behavioral treatment; behavioral treatment; insomnia severity index; predictors; treatment response

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (10)

• Toronto Alexithymia Scale (TAS-20)

  once at baseline assessment

• Sleep Latency

  once at baseline assessment

• Total Sleep Time

  once at baseline assessment

Study Arms (2)

zopiclone first group

EXPERIMENTAL

underwent the medication therapy (zopiclone) for the first two weeks followed by brief behavioral therapy

Behavioral: Brief behavioral therapy; Drug: Zopiclone

BBT-I first group

EXPERIMENTAL

received two-week brief behavioral therapy followed by medication therapy (zopiclone).

Behavioral: Brief behavioral therapy; Drug: Zopiclone

Interventions

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.

Also known as: BBT-I

BBT-I first group; zopiclone first group

Zopiclone DRUG

zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks

Also known as: hypnotic

BBT-I first group; zopiclone first group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meeting the criteria for chronic insomnia according ICSD-3 willingness to take part in the study and signed informed consent form

You may not qualify if:

• unability to stop taking medications that have a proven impact on sleep at least one week before and during the study;
• history of alcohol or drug abuse;
• major depressive disorder or other severe mental disorder identified by a clinical assessment and medical history;
• dementia;
• pregnancy or lactation;
• shift or night work;
• medical problems that would be a direct cause of sleep complaints: moderate/severe sleep apnea, defined as an apnea-hypopnea index of ≥15 events per hour, periodic limb movement disorder defined as a periodic leg movement index ≥15 events per hour or restless legs syndrome;
• other serious chronic conditions or exacerbation of chronic disorder preventing further participation.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Related Publications (1)

• 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.

  PMID: 28777364 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

zopiclone; Hypnotics and Sedatives

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Polina Pchelina
• Organization: I.M. Sechenov First Moscow State Medical University

polbox@mail.ru

+79036701725

Study Officials

• Polina Pchelina, PG student

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate student. Institute of Professional Education, Chair of Neurology. I.M. Sechenov First Moscow State Medical University

Model Details: 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 Record Dates

• First Submitted: October 17, 2017
• First Posted: November 13, 2017
• Study Start: April 7, 2015
• Primary Completion: March 14, 2017
• Study Completion: March 14, 2017
• Last Updated: September 16, 2019
• Results First Posted: June 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share