Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2023-12-02
2025-12-31
Brief Summary
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The main question it aims to answer is:
• Does Sleep School (a therapy for insomnia) work well to decrease harm of insomnia? Participants will attend a group therapy intervention once a week for six weeks.
Researchers will compare Sleep School to treatment as usual (short counselling by an educated nurse) to see if the Sleep School works better than treatment as usual in decreasing the harm of insomnia.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sleep School
Participants attend the Sleep School once a week for six weeks.
Sleep School
Sleep school is a structured method for the treatment of insomnia, which is based on cognitive behavioral therapy for insomnia (CBT-I). The central element of the method is a workbook for the patients. The essential parts of the method are strengthening the patient's self-efficacy, introducing the therapeutic exercises, and supporting the continued use of the exercises. The main themes of the Sleep school are information about sleep and the factors affecting it, behavioural components of CBT-I, like restricting the time spent in bed, cognitive components of CBT-I, like constructive worrying -exercise, and the exercises that aim to calm down mind and the autonomic nervous system. The Sleep School is held by an educated nurse.
Treatment as usual
Participants receive short counselling about insomnia at the enrollment visit.
Treatment as usual
Oral and written information about improving sleep habits given by an educated nurse.
Interventions
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Sleep School
Sleep school is a structured method for the treatment of insomnia, which is based on cognitive behavioral therapy for insomnia (CBT-I). The central element of the method is a workbook for the patients. The essential parts of the method are strengthening the patient's self-efficacy, introducing the therapeutic exercises, and supporting the continued use of the exercises. The main themes of the Sleep school are information about sleep and the factors affecting it, behavioural components of CBT-I, like restricting the time spent in bed, cognitive components of CBT-I, like constructive worrying -exercise, and the exercises that aim to calm down mind and the autonomic nervous system. The Sleep School is held by an educated nurse.
Treatment as usual
Oral and written information about improving sleep habits given by an educated nurse.
Eligibility Criteria
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Inclusion Criteria
* insomnia symptoms present at least for 3 months
Exclusion Criteria
* acute suicidality
* acute psychotic symptoms
18 Years
ALL
No
Sponsors
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University of Eastern Finland
OTHER
University of Turku
OTHER
Responsible Party
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Päivi Korhonen
Professor of General Practice
Principal Investigators
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Päivi Korhonen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Turku
Locations
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University of Turku
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Elina Bergman
Role: primary
References
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Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
Kyle SD, Morgan K, Espie CA. Insomnia and health-related quality of life. Sleep Med Rev. 2010 Feb;14(1):69-82. doi: 10.1016/j.smrv.2009.07.004. Epub 2009 Dec 4.
Lallukka T, Kaikkonen R, Harkanen T, Kronholm E, Partonen T, Rahkonen O, Koskinen S. Sleep and sickness absence: a nationally representative register-based follow-up study. Sleep. 2014 Sep 1;37(9):1413-25. doi: 10.5665/sleep.3986.
Overland S, Glozier N, Sivertsen B, Stewart R, Neckelmann D, Krokstad S, Mykletun A. A comparison of insomnia and depression as predictors of disability pension: the HUNT Study. Sleep. 2008 Jun;31(6):875-80. doi: 10.1093/sleep/31.6.875.
Daley M, Morin CM, LeBlanc M, Gregoire JP, Savard J, Baillargeon L. Insomnia and its relationship to health-care utilization, work absenteeism, productivity and accidents. Sleep Med. 2009 Apr;10(4):427-38. doi: 10.1016/j.sleep.2008.04.005. Epub 2008 Aug 26.
Javaheri S, Redline S. Insomnia and Risk of Cardiovascular Disease. Chest. 2017 Aug;152(2):435-444. doi: 10.1016/j.chest.2017.01.026. Epub 2017 Jan 30.
Johnson KA, Gordon CJ, Chapman JL, Hoyos CM, Marshall NS, Miller CB, Grunstein RR. The association of insomnia disorder characterised by objective short sleep duration with hypertension, diabetes and body mass index: A systematic review and meta-analysis. Sleep Med Rev. 2021 Oct;59:101456. doi: 10.1016/j.smrv.2021.101456. Epub 2021 Jan 23.
Baglioni C, Battagliese G, Feige B, Spiegelhalder K, Nissen C, Voderholzer U, Lombardo C, Riemann D. Insomnia as a predictor of depression: a meta-analytic evaluation of longitudinal epidemiological studies. J Affect Disord. 2011 Dec;135(1-3):10-9. doi: 10.1016/j.jad.2011.01.011. Epub 2011 Feb 5.
Ong JC, Crawford MR, Wallace DM. Sleep Apnea and Insomnia: Emerging Evidence for Effective Clinical Management. Chest. 2021 May;159(5):2020-2028. doi: 10.1016/j.chest.2020.12.002. Epub 2020 Dec 10.
Ragnoli B, Pochetti P, Raie A, Malerba M. Comorbid Insomnia and Obstructive Sleep Apnea (COMISA): Current Concepts of Patient Management. Int J Environ Res Public Health. 2021 Sep 1;18(17):9248. doi: 10.3390/ijerph18179248.
Ballesio A, Aquino MRJV, Feige B, Johann AF, Kyle SD, Spiegelhalder K, Lombardo C, Rucker G, Riemann D, Baglioni C. The effectiveness of behavioural and cognitive behavioural therapies for insomnia on depressive and fatigue symptoms: A systematic review and network meta-analysis. Sleep Med Rev. 2018 Feb;37:114-129. doi: 10.1016/j.smrv.2017.01.006. Epub 2017 Feb 7.
Alimoradi Z, Jafari E, Brostrom A, Ohayon MM, Lin CY, Griffiths MD, Blom K, Jernelov S, Kaldo V, Pakpour AH. Effects of cognitive behavioral therapy for insomnia (CBT-I) on quality of life: A systematic review and meta-analysis. Sleep Med Rev. 2022 Aug;64:101646. doi: 10.1016/j.smrv.2022.101646. Epub 2022 May 10.
van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3-16. doi: 10.1016/j.smrv.2017.02.001. Epub 2017 Feb 9.
van der Zweerde T, Bisdounis L, Kyle SD, Lancee J, van Straten A. Cognitive behavioral therapy for insomnia: A meta-analysis of long-term effects in controlled studies. Sleep Med Rev. 2019 Dec;48:101208. doi: 10.1016/j.smrv.2019.08.002. Epub 2019 Aug 12.
Other Identifiers
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VARHA/480/13.02.02/2023
Identifier Type: -
Identifier Source: org_study_id