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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

Online insomnia treatment for wait-list patients in mental health care. A randomized controlled multicenter trial.

Alternative title: Nettbasert insomnibehandling for venteliste-pasienter i psykisk helsevern. En randomisert kontrollert multisenter studie.

Awarded: NOK 14.5 mill.

Sleep is a fundamental human need with large impact on health and functioning. For patients with mental disorders, 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 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 other symptoms of mental disorders. However, a major problem has been disseminating CBT-I and few therapists are trained in this treatment. Consequently, most patients receive sleep medication although evidence clearly indicate that CBT-I is more effective and should be the treatment of choice. In Norway, 7% of the general population are prescribed hypnotics each year, with numbers likely to be higher in mental health care. A fully automated, online version of CBT-I is effective to otherwise healthy people with sleep problems, but has not been tested in patients with comorbid sleep problems and other mental health issues. The project is designed as a multi-center clinical trial where patients on the wait list to receive ordinary outpatient treatment in community mental health care clinics will be randomized to online CBT-I or an online control intervention. The aims are to test if digital CBT-I is effective in this patient group and if it can improve outcomes of ordinary treatment and reduce medication use. The last year, inclusion in the trial has started and we have published the trial protocol and data on digital CBT-I in Norway. As of today (August 12, 2021) inclusion takes place in 22 Norwegian mental health care outpatient clinics. All patients who have will receive treatment for a mental disorder at the clinics also receive an invitation to the trial. So far, 219 patients have been evaluated to meet the eligibility criteria and have been included in the trial.

Sleep is a fundamental human need with large impact on 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. This makes sleep disturbance a potential trans-diagnostic therapeutic target in the treatment of mental disorders. The treatment of choice for insomnia is Cognitive Behavior Therapy for Insomnia (CBT- I), but a major problem has been disseminating CBT-I and few therapists are trained in this treatment. Consequently, most patients receive medication although evidence clearly indicate that CBT-I is more effective. Based on previous research from our group, a highly effective, fully automated, online version of CBT-I have been developed. This could be used to treat a large number of patients while they are still on the wait list to receive ordinary treatment in mental health care. The main aims are to test if online CBT-I is effective in this patient group and if it can improve outcomes of ordinary treatment and reduce medication use. In a multi-center clinical trial, 800 patients will be randomized to online CBT-I or an online control intervention. The major challenges are recruitment of patients and attrition. Based on our previous experience, we have attempted to limit these problems in the online infrastructure, the multi-center approach, and using local coordinators to ensure complete data collection. Lack of access to evidence-based treatments is a great challenge within the Norwegian mental health care system. The current project may result in improved implementation of a low-threshold and evidence based treatment for a large patient group with great negative individual and socioeconomic outcomes. If proven successful, our aim is to implement this intervention as standard treatment in Norway, potentially changing how our current health care system is treating sleep and coexisting mental problems.

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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering