NCT04621643: Norse4

Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in Individuals Referred to Public Mental Health Services in Norway

Completed NA Last updated 26 February 2025

What this trial tests

NA trial testing digital cognitive behavioral therapy (dCBT-I) in Mental Disorder in 911 participants. Completed in 30 June 2024.

Timeline

24 November 2020

Primary endpoint
30 June 2024

30 June 2024

Quick facts

Lead sponsor	St. Olavs Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	911
Start date	24 November 2020
Primary completion	30 June 2024
Estimated completion	30 June 2024
Sites	4 locations across Norway

Drugs / interventions tested

• digital cognitive behavioral therapy (dCBT-I)
• Digital patient education about insomnia (PE)

Conditions studied

• Mental Disorder — all drugs for Mental Disorder →
• Insomnia — all drugs for Insomnia →

Sponsor

St. Olavs Hospital

Who can join

18 and older, any sex, with Mental Disorder or Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sleep is a fundamental human need with large impact on both psychological and somatic functioning. However, for patients with mental disorders, sleep is often disturbed. Across all diagnostic groups, sleep disturbance is one of the most common and disruptive symptoms. For decades it has been assumed that the sleep disturbance these patients experience was a secondary symptom of a primary mental disorder, but recently this has changed. Experimental and clinical data now suggest that there is a reciprocal relationship between sleep disturbance and mental disorders where they perpetuate and aggravate each other. This makes sleep disturbance a potential therapeutic target in the treatment of mental disorders. Evidence emerging the last decade indicate that providing Cognitive Behavior Therapy for Insomnia (CBT-I) to patients with mental disorders not only improves sleep, but also has clinically meaningful effects on their primary mental disorder. However, a major problem has been disseminating CBT-I and few therapists are trained in this intervention. Consequently, most patients receive sleep medication although evidence clearly indicate that CBT-I is more effective and should be the treatment of choice. In this study, the investigators will use a fully automated digital version of CBT-I that might be used to treat a large number of patients while they are still on the waiting list to receive ordinary outpatient treatment in secondary mental health care clinics in Norway. The main goal is to test the effectiveness of digital CBT-I for this patient group.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Digital cognitive-behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial.
   Kallestad H, Saksvik S, Vedaa Ø, Langsrud K, et al · · 2021 · cited 6× · PMID 34183350 · DOI 10.1136/bmjopen-2021-050661