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

Summary

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.

Conditions

• Mental Disorder
• Insomnia

Interventions

BEHAVIORAL

digital cognitive behavioral therapy (dCBT-I)

dCBT-I during 9 weeks. Multicomponent intervention that includes the following: psychoeducation about sleep, sleep hygiene, sleep restriction therapy, stimulus control and challenging beliefs and perception about sleep. The digital CBT-I that will be utilized in this study is named Sleep Healthy Using The internet (SHUTi). The intervention is fully automated with no contact with health care personnel, it is interactive and adapts to input from the users. It comprises of the same elements included in face-to-face CBT-I, but the user gains access to a new educational, behavioral or cognitive module each week only after completion of digital sleep diaries. dCBT-I can be accessed on computers or hand-held devices

BEHAVIORAL

Digital patient education about insomnia (PE)

Control condition PE during 9 weeks. A digital patient education program that can be accessed on computers or hand-held devices. The information overlaps with that included in the dCBT-I intervention but it does not include any of the interactive features of the dCBT-I intervention and all the information is available from the moment the PE site is opened.

Sponsors & Collaborators

• Norwegian University of Science and Technology

  collaborator OTHER

• Folkehelseinstituttet

  collaborator UNKNOWN

• University Hospital, Akershus

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• University of Virginia

  collaborator OTHER

• University of California, Berkeley

  collaborator OTHER

• Helse Møre og Romsdal HF

  collaborator OTHER_GOV

• St. Olavs Hospital

  lead OTHER

Principal Investigators

• Pål Sandvik, md · St Olavs Hospital, Division of Mental Health Care

• Håvard Kallestad, phd · Norwegian University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-24

Primary Completion

2024-06-30

Completion

2024-06-30

Countries

• Norway

Study Locations