NCT06149273

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Dec 2023Dec 2029

First Submitted

Initial submission to the registry

June 27, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 2, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

June 27, 2023

Last Update Submit

April 30, 2026

Conditions

Insomnia Chronic

Keywords

Cognitive behavioral therapy for insomniaCBT-IPrimary careInsomnia severity indexQuality of lifeDepressive symptoms

Outcome Measures

Primary Outcomes (1)

  • Mean Change from Baseline in Insomnia Severity Index (ISI) score at 8 weeks

    The ISI is a validated self-report tool for assessing the severity, and impact of current insomnia symptoms. It consists of 7 Likert-scale questions with a total score ranging from 0 to 28 (with higher scores indicating more severe insomnia). Change = Week 8 score - Baseline score.

    Baseline and Week 8

Secondary Outcomes (3)

  • Mean change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at 8 weeks

    Baseline and Week 8

  • Mean change from Baseline in EUROHIS Quality of Life 8-item Index at 8 weeks

    Baseline and Week 8

  • Mean change from Baseline in Work Ability Score (WAS) at 8 weeks

    Baseline and Week 8

Other Outcomes (24)

  • Sleep Duration at Baseline

    Baseline

  • Sleep Stages at Baseline

    Baseline

  • Sleep Quality at Baseline

    Baseline

  • +21 more other outcomes

Study Arms (2)

Sleep School

EXPERIMENTAL

Participants attend the Sleep School once a week for six weeks.

Behavioral: Sleep School

Treatment as usual

ACTIVE COMPARATOR

Participants receive short counselling about insomnia at the enrollment visit.

Behavioral: Treatment as usual

Interventions

Sleep SchoolBEHAVIORAL

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.

Sleep School
Treatment as usualBEHAVIORAL

Oral and written information about improving sleep habits given by an educated nurse.

Treatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turku

Turku, 20014, Finland

RECRUITING

Related Publications (14)

  • 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.

    PMID: 28875581BACKGROUND

  • 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: 19962922BACKGROUND

  • 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: 25142569BACKGROUND

  • 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: 18548833BACKGROUND

  • 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: 18753000BACKGROUND

  • 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: 28153671BACKGROUND

  • 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: 33640704BACKGROUND

  • 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: 21300408BACKGROUND

  • 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.

    PMID: 33309524BACKGROUND

  • 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.

    PMID: 34501836BACKGROUND

  • 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.

    PMID: 28619248BACKGROUND

  • 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.

    PMID: 35653951BACKGROUND

  • 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.

    PMID: 28392168BACKGROUND

  • 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.

    PMID: 31491656BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Päivi Korhonen, PhD

    University of Turku

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elina Bergman, PhD

CONTACT

0elkaro@utu.fi

Ansa Rantanen, PhD

CONTACT

atsipp@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of General Practice

Study Record Dates

First Submitted

June 27, 2023

First Posted

November 28, 2023

Study Start

December 2, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Data will be available from the study principal investigator upon reasonable request.

Locations

FI(1)