Clinical trial NCT06149273: Treatment of Insomnia in Primary Care Study
Official title: Treatment of Insomnia in Primary Care Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Chronic
Keywords: Cognitive behavioral therapy for insomnia
CBT-I
Primary care
Insomnia severity index
Quality of life
Depressive symptoms
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2023-11-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean Change from Baseline in Insomnia Severity Index (ISI) score at 8 weeks
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Mean change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at 8 weeks
timeFrame: Baseline and Week 8
measure: Mean change from Baseline in EUROHIS Quality of Life 8-item Index at 8 weeks
timeFrame: Baseline and Week 8
measure: Mean change from Baseline in Work Ability Score (WAS) at 8 weeks
timeFrame: Baseline and Week 8
Other outcomes:
measure: Sleep Duration at Baseline
timeFrame: Baseline
measure: Sleep Stages at Baseline
timeFrame: Baseline
measure: Sleep Quality at Baseline
timeFrame: Baseline
measure: Sleep Duration at 8 weeks
timeFrame: Week 8
measure: Sleep Stages at 8 weeks
timeFrame: Week 8
measure: Sleep Quality at 8 weeks
timeFrame: Week 8
measure: Mean Change from 8 weeks in Insomnia Severity Index (ISI) score at 16 weeks
timeFrame: Week 8 and Week 16
measure: Mean change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at 16 weeks
timeFrame: Baseline and Week 16
measure: Mean change from Baseline in EUROHIS Quality of Life 8-item Index at 16 weeks
timeFrame: Baseline and Week 16
measure: Mean change from Baseline in Work Ability Score (WAS) at 16 weeks
timeFrame: Baseline and Week 16
measure: Sleep Duration at 16 weeks
timeFrame: Week 16
measure: Sleep Stages at 16 weeks
timeFrame: Week 16
measure: Sleep Quality at 16 weeks
timeFrame: Week 16
measure: Mean Change from 8 weeks in Insomnia Severity Index (ISI) score at 26 weeks
timeFrame: Week 8 and Week 26
measure: Mean change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at 26 weeks
timeFrame: Baseline and Week 26
measure: Mean change from Baseline in EUROHIS Quality of Life 8-item Index at 26 weeks
timeFrame: Baseline and Week 26
measure: Mean change from Baseline in Work Ability Score (WAS) at 26 weeks
timeFrame: Baseline and Week 26
measure: Sleep Duration at 26 weeks
timeFrame: Week 26
measure: Sleep Stages at 26 weeks
timeFrame: Week 26
measure: Sleep Quality at 26 weeks
timeFrame: Week 26
measure: Mean Change from 8 weeks in Insomnia Severity Index (ISI) score at 12 months
timeFrame: Week 8 and 12 Months
measure: Mean change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at 12 months
timeFrame: Baseline and 12 Months
measure: Mean change from Baseline in EUROHIS Quality of Life 8-item Index at 12 months
timeFrame: Baseline and 12 Months
measure: Mean change from Baseline in Work Ability Score (WAS) at 12 months
timeFrame: Baseline and 12 Months
Locations:
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: University of Turku
name: Päivi Korhonen, PhD
role: PRINCIPAL_INVESTIGATOR
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