Прогностический и предиктивный анализы эффективности фармакологического и нелекарственного подходов к лечению хронической инсомнии
Прогностический и предиктивный анализы эффективности фармакологического и нелекарственного подходов к лечению хронической инсомнии
Пчелина П.В., Полуэктов М.Г. Прогностический и предиктивный анализы эффективности фармакологического и нелекарственного подходов к лечению хронической инсомнии. Consilium Medicum. 2021;23(11):818–824. DOI: 10.26442/20751753.2021.11.201154
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Pchelina PV, Poluektov MG. Prognostic and predictive analysis of effectiveness of pharmacological and non-pharmaceutical treatment approaches for chronic insomnia. Consilium Medicum. 2021;23(11):818–824.
DOI: 10.26442/20751753.2021.11.201154
Прогностический и предиктивный анализы эффективности фармакологического и нелекарственного подходов к лечению хронической инсомнии
Пчелина П.В., Полуэктов М.Г. Прогностический и предиктивный анализы эффективности фармакологического и нелекарственного подходов к лечению хронической инсомнии. Consilium Medicum. 2021;23(11):818–824. DOI: 10.26442/20751753.2021.11.201154
________________________________________________
Pchelina PV, Poluektov MG. Prognostic and predictive analysis of effectiveness of pharmacological and non-pharmaceutical treatment approaches for chronic insomnia. Consilium Medicum. 2021;23(11):818–824.
DOI: 10.26442/20751753.2021.11.201154
Обоснование. В настоящее время существует проблема низкой доступности наиболее эффективного и безопасного метода лечения хронической инсомнии – когнитивно-поведенческой терапии (КПТ-И), решением которой является разработка сокращенных и удаленных методик. Необходимо выявить предикторы эффективности этих подходов для достижения быстрого результата лечения. Цель. Поиск предикторов эффективности терапии с применением снотворного средства и сокращенного варианта КПТ-И – структурированной методики терапии инсомнии (СМТ-И). Материалы и методы. Проанализированы данные 42 участников рандомизированного исследования, получавших 1 из 2 видов терапии хронической инсомнии в течение 2 нед: зопиклон в дозировке 7,5 мг или СМТ-И. Основным показателем эффективности лечения было снижение индекса тяжести инсомнии (ИТИ). В качестве предикторов проанализированы демографические, анамнестические, полисомнографические показатели, фоновые результаты по шкале депрессии Бека, шкале тревоги Спилбергера, Торонтской алекситимической шкале, индексу гигиены сна, шкале дисфункциональных убеждений в отношении сна, Эпвортской шкале сонливости. Проведены прогностический анализ с построением моделей простой линейной регрессии и предиктивный анализ с построением моделей множественной линейной регрессии с взаимодействием. Эти анализы позволили исследовать эффект потенциальных предикторов снижения ИТИ сразу после курса лечения и через 2 нед динамического наблюдения после терапии. Результаты. Прогностически значимыми для определения эффекта лечения оказались: большее количество пробуждений в течение ночи, которое обеспечивало снижение ИТИ на 0,2202 пункта (p=0,05) с каждым дополнительным пробуждением, и большая представленность I стадии медленного сна, которая улучшала показатель эффективности на 0,55 пункта (p=0,039) с каждым процентом от общего времени сна. Прогноз терапии ухудшался на 0,233 пункта (p=0,047) с каждым баллом по шкале депрессии Бека при фоновом исследовании и на 0,2 пункта (р=1,55e-06) с каждым годом возраста. Клиническими предикторами лучшего ответа на СМТ-И оказались отсутствие жалоб на длительное засыпание, отсутствие употребления агонистов ГАМКергических рецепторов в анамнезе и более высокий балл по Эпвортской шкале сонливости. Заключение. Частота пробуждений, представленность I стадии сна, уровень депрессии, возраст, уровень дневной сонливости – предикторы эффективности СМТ-И, что следует учитывать при назначении сокращенного (2–4 нед) или полного (6–8 нед) курса КПТ-И.
Background. Limited access to cognitive behavioral therapy for insomnia (CBT-I) which is the most effective and safe treatment approach for chronic insomnia leads to the elaboration of shortened and interned delivered CBT-I methods. Investigation of effectiveness predictors of the new methods is important for their better result. Aim. Investigation of effectiveness predictors for pharmacotherapy and CBT-I based brief behavioral therapy for insomnia (BBT-I). Materials and methods. The data for the analysis were acquired from a randomized study of 42 participants with chronic insomnia who received either zopiclone 7.5 mg or BBT-I for 2 weeks. The difference of the insomnia severity index from pre- to post-treatment was the main outcome measure. Potential predictors included demographic and medical history data, objective sleep characteristics, baseline scores of Beck depression inventory (BDI), Spielberger anxiety scale, Toronto alexithymia scale, sleep hygiene index, dysfunctional beliefs and attitudes about sleep scale, Epworth sleepiness scale. Univariate linear regression analysis was used for prognostic analysis. To identify predictors of treatment outcome after the treatment course and after the 2 weeks follow-up we used multiple linear regression models with interaction. Results. In the prognostic analysis higher amount of awakenings during the night and a higher proportion of the 1 stage NREM sleep measured objectively correlated with better outcome E=0.2202 (p=0.05) and E=0.55 (p=0.039) respectively. Older age and higher baseline BDI score significantly worsened the outcome: E=0.233 (p=0.047) and E=0.2 (р=1.55e-06) respectively. Clinical predictors of the BBT-I effectiveness were an absence of the sleep onset problems and absence of GABA hypnotics use in medical history and the higher baseline daytime sleepiness. Conclusion. Neurophysiological (frequency of awakenings, percentage of the sleep stage N1) and clinical (severity of depression, age, daytime sleepiness) predictors of the effectiveness of BBT-I were revealed. This findings will help to select the patients who should undergo a shortened course of CBT-I.
Keywords: sleep, cognitive behavioral therapy for insomnia, brief behavioral therapy for insomnia, chronic insomnia, effectiveness predictors, regression analysis
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________________________________________________
1. American Academy of Sleep Medicine.Тhe international classification of sleep disorders, revised: Diagnostic and coding manual. Chicago, Illinois: American Academy of Sleep Medicine, 2014.
2. Golenkov AV, Poluektov MG. Prevalence of sleep disorders in citizens of Chuvash Republic (results from complete interview study). Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. 2011;111:64-7 (in Russian)
3. Kessler RC, Berglund PA, Coulouvrat C, et al. Insomnia, Comorbidity, and Risk of Injury Among Insured Americans: Results from the America Insomnia Survey. Sleep. 2012;35(6):825-34. DOI:10.5665/sleep.1884
4. Morin CM, Leblanc M, Daley M, et al. Epidemiology of insomnia: Prevalence, self-help treatments, consultations, and determinants of help-seeking behaviors. Sleep Med. 2006;7:123-30. DOI:10.1016/j.sleep.2005.08.008
5. Poluektov MG, Buzunov RV, Averbukh VM, et al. Project of clinical recommendations on diagnosis and treatment of chronic insomnia in adults. Neurology and Rheumatology (Suppl. Consilium Medicum). 2016;2:41-51 (in Russian)
6. Riemann D, Baglioni C, Bassetti C, et al. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017;26(6):675-700. DOI:10.1111/jsr.12594
7. Edinger JD, Carney CE. Overcoming insomnia: A cognitive-behavioral therapy approach, therapist guide. Oxford University Press, 2014.
8. Currie CL, Kuzmina MV, Nadyuk RI. The Counseling Profession in Russia: Historical Roots, Current Trends, and Future Perspectives. J Couns Dev. 2012;90:488-93.
DOI:10.1002/j.1556-6676.2012.00060.x
9. World Health Organisation. Global Health Observatory (GHO) data. 2018. Available at: https://www.who.int/data/gho. Accessed: 30.08.2021.
10. Wilson SJ, Nutt DJ, Alford C, et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders.
J Psychopharmacol. 2010;24(11):1577-601. DOI:10.1177/0269881110379307
11. Everitt H, McDermott L, Leydon G, et al. GPs’ management strategies for patients with insomnia. Br J Gen Pract. 2014;64(619):e112-9. DOI:10.3399/bjgp14X677176
12. Weaver MF. Prescription Sedative Misuse and Abuse. Yale J Biol Med. 2015;88:247-56.
13. Substance Abuse and Mental Health Services Administration, Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014.
14. Morin CM, Vallières A, Guay B, et al. Cognitive Behavioral Therapy, Singly and Combined With Medication, for Persistent Insomnia: a Randomized Controlled Trial. JAMA. 2009;301(19):2005-15. DOI:10.1001/jama.2009.682
15. Buysse DJ, Germain A, Moul DE, et al. Efficacy of Brief Behavioral Treatment for Chronic Insomnia in Older Adults. Arch Intern Med. 2011;171(10):887-95. DOI:10.1001/archinternmed.2010.535
16. Seyffert M, Lagisetty P, Landgraf J, et al. Internet-delivered cognitive behavioral therapy to treat insomnia: A systematic review and meta-analysis. PLoS One. 2016;11(2):e0149139. DOI:10.1371/journal.pone.0149139
17. Zachariae R, Lyby MS, Ritterband LM, O’Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia – A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016;30:1-10. DOI:10.1016/j.smrv.2015.10.004
18. Pchelina PV, Tabidze AA, Poluektov MG. Comparative study of effectiveness of cognitive-behavior therapy and zopiclone for chronic insomnia. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. Spetsvypuski. 2017;117(2):48-55 (in Russian)
DOI:10.17116/jnevro20171174248-55
19. Bastien CH, Vallières A, Morin CM. Validation of the insomnia severity index as an outcome measure for insomnia research. Sleep Med. 2001;2(4):297-307.
DOI:10.1016/S1389-9457(00)00065-4
20. Morin CM, Belleville G, Bélanger L, Ivers H. The insomnia severity index: Psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011;34(5):601-8. DOI:10.1093/sleep/34.5.601
21. Рассказова Е.И. Нарушения психологической саморегуляции при невротической инсомнии: дис. ... канд. психол. наук. М.: Изд-во МГУ, 2008 [Rasskazova EI. Narusheniia psikhologicheskoi samoreguliatsii pri nevroticheskoi insomnii: dis. ... kand. psikhol. nauk. Moscow: MSU Publishing, 2008 (in Russian)].
22. Berry RB, Budhiraja R, Gottlieb DJ, et al. Rules for Scoring Respiratory Events in Sleep: Update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events: Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012;8(5):597-619. DOI:10.5664/jcsm.2172
23. Beck AT, Steer RA, Brown G. Manual for the Beck Depression Inventory-II. San Antonio: TX: Psychological Corporation, 1996.
24. Spielberger CD, Gorsuch RL, Lushene R, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press, 1983.
25. Bagby M, Parker JDA, Taylor GJ. The twenty-item Toronto Alexithymia Scale – I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994;38(1):23-32. DOI:10.1016/0022-3999(94)90005-1
26. Mastin DF, Bryson J, Corwyn R. Assessment of sleep hygiene using the sleep hygiene index. J Behav Med. 2006;29(3):223-7. DOI:10.1007/s10865-006-9047-6
27. Van Buuren S, Groothuis-Oudshoorn CGM. Mice: Multivariate Imputation by Chained Equations in R. J Stat Softw. 2011;45(3):1-67. DOI:10.18637/jss.v045.i03
28. Wulff JN, Ejlskov L. Multiple Imputation by Chained Equations in Praxis: Guidelines and Review. Electronic J Business Res Methods. 2017;15(1):41-56.
29. Harrell FE. Regression Modeling Strategies With Applications to Linear Models, Logistic and Ordinal Regression, and Survival Analysis. Switzerland: Springer International Publishing, 2015. DOI:10.1007/978-3-319-19425-7_10
30. Espie CA, Inglis SJ, Harvey L. Predicting clinically significant response to cognitive behavior therapy for chronic insomnia in general medical practice: Analyses of outcome data at 12 months posttreatment. J Consult Clin Psychol. 2001;69(1):58-66. DOI:10.1037//0022-006X.69.1.58
31. Batterham PJ, Christensen H, Mackinnon AJ, et al. Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression. BJPsych Open. 2017;3(5):228-35. DOI:10.1192/bjpo.bp.117.005231
32. Cui R, Fiske A. Predictors of treatment attendance and adherence to treatment recommendations among individuals receiving Cognitive Behavioral Therapy for Insomnia. Cogn Behav Ther. 2020;49(2):113-9. DOI:10.1080/16506073.2019.1586992
33. Alperson J, Biglan A. Self-administered treatment of sleep onset insomnia and the importance of age. Behav Ther. 1979;10(3):347-56. DOI:10.1016/S0005-7894(79)80024-6
34. Lovato N, Lack L, Kennaway DJ. Comparing and contrasting therapeutic effect of cognitive-behavior therapy for older adults suffering from insomnia with short and long objective sleep duration. Sleep Med. 2016;4:4-12. DOI:10.1016/j.sleep.2016.04.001
35. Blom K, Jernelöv S, Kraepelien M, et al. Internet Treatment Addressing either Insomnia or Depression, for Patients with both Diagnoses: A Randomized Trial. Sleep. 2015;38(2):267-77. DOI:10.5665/sleep.4412
36. Troxel WM, Conrad TS, Germain A, Buysse DJ. Predictors of treatment response to brief behavioral treatment of insomnia (BBTI) in older adults. J Clin Sleep Med. 2013;9(12):1281-9. DOI:10.5664/jcsm.3270
37. Van de Laar M, Pevernagie D, van Mierlo P, Overeem S. Psychiatric Comorbidity and Aspects of Cognitive Coping Negatively Predict Outcome in Cognitive Behavioral Treatment of Psychophysiological Insomnia. Behav Sleep Med. 2015;13(2):140-56.
DOI:10.1080/15402002.2013.845781
38. Van Houdenhove L, Buyse B, Gabriëls L, Van Den Bergh O. Treating primary insomnia: Clinical effectiveness and predictors of outcomes on sleep, daytime function and health-related quality of life. J Clin Psychol Med Settings. 2011;18(3):312-21. DOI:10.1007/s10880-011-9250-7
39. Vgontzas AN, Liao D, Bixler EO, et al. Insomnia with Objective Short Sleep Duration is Associated with a High Risk for Hypertension. Sleep. 2009;32(4):491-7. DOI:10.1093/sleep/32.4.491
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Авторы
П.В. Пчелина*, М.Г. Полуэктов
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*polbox@mail.ru
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Polina V. Pchelina*, Mikhail G. Poluektov
Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*polbox@mail.ru