Treatment of Insomnia in Primary Care Study

Not Applicable

Recruiting

• Conditions: Insomnia Chronic
• Interventions: Behavioral: Treatment as usual; Behavioral: Sleep School

• Registration Number: NCT06149273
• Lead Sponsor: University of Turku

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-28
• Study Start: 2023-12-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Treatment as usual	Participants receive short counselling about insomnia at the enrollment visit.
Sleep School	Sleep School	Participants attend the Sleep School once a week for six weeks.

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline in Insomnia Severity Index (ISI) score at 8 weeks	Baseline and Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Mean change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at 8 weeks	Baseline and Week 8	PHQ-9 is a validated self-administered instrument assessing each of the 9 Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria for depression as 0 (not at all) to 3 (nearly every day), and the severity of depression. Possible scores range from 0 to 27. Change = Week 8 score - Baseline score.
Mean change from Baseline in EUROHIS Quality of Life 8-item Index at 8 weeks	Baseline and Week 8	EUROHIS Quality of Life 8-item Index is a validated instrument for the assessment of general quality of life. There are altogether eight questions about the general, physical, psychological, social, and environmental aspects of quality of life. Every question is scored from 1 (very poor) to 5 (very good). All scores can be added together and divided by 8 (the sum of the questions) to obtain the EUROHIS-QOL mean score. Change = Week 8 score - Baseline score.
Mean change from Baseline in Work Ability Score (WAS) at 8 weeks	Baseline and Week 8	The WAS is the first item of the Work Ability Index (WAI), a validated instrument for the assessment of work ability. WAS is a single question "What is your current work ability compared to your lifetime best?" It has a 0-10 response scale, where 0 stands for "completely unable to work" and 10 stands for "work ability at its best." The WAS has been shown to have a strong association with the WAI and is reliable in evaluating work ability. Change = Week 8 score - Baseline score.

Trial Locations

Locations (1)

University of Turku; 🇫🇮 Turku, Finland