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Treatment of Insomnia in Primary Care Study

NCT06149273 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Insomnia Chronic

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, 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.

BEHAVIORAL

Treatment as usual

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

Sponsors & Collaborators

  • University of Eastern Finland

    collaborator OTHER

  • University of Turku

    lead OTHER

Principal Investigators

  • Päivi Korhonen, PhD · University of Turku

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-02
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06149273 on ClinicalTrials.gov