Treatment of Insomnia in Primary Care Study (TIP)

University of Turku

Status: Enrolling

Conditions: Insomnia Chronic

Treatments: Behavioral: Treatment as usual; Behavioral: Sleep School

Study type: Interventional

Funder types: Other

Identifiers

NCT06149273

VARHA/480/13.02.02/2023

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Sleep School

Experimental group

Description:

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

Treatment:

Behavioral: Sleep School

Treatment as usual

Active Comparator group

Description:

Participants receive short counselling about insomnia at the enrollment visit.

Treatment:

Behavioral: Treatment as usual