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Recruiting NCT06149273

Treatment of Insomnia in Primary Care Study

No phase Interventional Insomnia Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep School, Treatment as usual.
Who it may be relevant to
Registry conditions: Insomnia Chronic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this clinical trial is to learn about insomnia treatment among primary care patients with chronic insomnia. 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.

Interventions

  • Behavioral 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,
  • Behavioral Treatment as usual
    Oral and written information about improving sleep habits given by an educated nurse.

Primary outcome measures

  • Mean Change from Baseline in Insomnia Severity Index (ISI) score at 8 weeks [Time frame: Baseline and Week 8]
Secondary outcome measures (3)
  • Mean change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at 8 weeks [Time frame: Baseline and Week 8]
  • Mean change from Baseline in EUROHIS Quality of Life 8-item Index at 8 weeks [Time frame: Baseline and Week 8]
  • Mean change from Baseline in Work Ability Score (WAS) at 8 weeks [Time frame: Baseline and Week 8]

Eligibility criteria

Inclusion criteria

  • Insomnia severity index (ISI) score at least 8
  • insomnia symptoms present at least for 3 months

Exclusion criteria

  • diagnosed dementia based on medical records
  • acute suicidality
  • acute psychotic symptoms

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 1 center
  • University of Turku — Turku

Publications

  • 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 treatmen PMID 28875581
  • 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. PMID 19962922
  • 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. PMID 25142569
  • 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. PMID 18548833
  • 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. PMID 18753000
  • 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. PMID 28153671
  • 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. PMID 33640704
  • 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. PMID 21300408

Identifiers

NCT: NCT06149273 · VARHA/480/13.02.02/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗