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

NCT04621643 | Completed DMC

• 1 other identifier: 125068
• Study Type: interventional
• Target: 911
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Cognitive Behavioral Therapy; Patient Education; Telemedicine; Waiting Lists

Outcome Measures

Primary Outcomes (1)

• Between-group difference in insomnia severity at week 9 after randomization

  Assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.

  9 weeks after randomization

Secondary Outcomes (48)

• Between-group difference in insomnia severity at week 33 after randomization

  33 weeks after randomization

• Between-group difference in insomnia severity at week 61 after randomization

  61 weeks after randomization

• Prospective daily sleep-wake pattern at week 9 after randomization

  9 weeks after randomization

• Prospective daily sleep-wake pattern at week 33 after randomization

  33 weeks after randomization

• Prospective daily sleep-wake pattern at week 61 after randomization

  61 weeks after randomization

Study Arms (2)

digital cognitive behavioral therapy (dCBT-I)

EXPERIMENTAL

Behavioral: digital cognitive behavioral therapy (dCBT-I)

Patient education about sleep (PE)

ACTIVE COMPARATOR

Behavioral: Digital patient education about insomnia (PE)

Interventions

digital cognitive behavioral therapy (dCBT-I) BEHAVIORAL

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

digital cognitive behavioral therapy (dCBT-I)

Digital patient education about insomnia (PE) BEHAVIORAL

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.

Patient education about sleep (PE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent.
• Insomnia Severity Index (ISI) \> 11 We have used this cut-off score previously to identify individuals who are likely to be experiencing clinical significant insomnia and who will potentially benefit from the dCBT-I intervention. Kallestad et al 2018 and a trial from Norway (Filosa et al in press) suggest that this cut-off is the most sensitive to detect a diagnosis of Insomnia Disorder.

You may not qualify if:

• Sleep apnea screening: Positive endorsement of a screening question for sleep apnea (the item asks if they "usually or everyday snore and stop breathing and have difficulties staying awake during the day")
• Medical history indicative of (i) epilepsy plus self-report of \>=1 seizure \<12 months ago, or (ii) recent surgery for heart disease, or (iii) currently in an attack phase of multiple sclerosis.
• Individuals whose work schedule includes night shifts.
• Pregnancy
• Inadequate opportunity to sleep or circumstances prevent modification of sleep pattern (e.g. having a child aged\<12 months residing home).
• Currently receiving psychological treatment for insomnia.
• Not a patient at one of the participating clinics.
• Not having completed baseline assessment

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator
• Folkehelseinstituttet: collaborator
• University Hospital, Akershus: collaborator
• Helse Stavanger HF: collaborator
• University of Virginia: collaborator
• University of California, Berkeley: collaborator
• Helse Møre og Romsdal HF: collaborator

Study Sites (4)

Helse Møre og Romsdal HF

Ålesund, Norway

Location

AHUS

Oslo, Norway

Location

Stavanger Universitetssykehus

Stavanger, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• Kallestad H, Saksvik S, Vedaa O, Langsrud K, Morken G, Lydersen S, Simpson MR, Dorheim SK, Holmoy B, Selvik SG, Hagen K, Stiles TC, Harvey A, Ritterband L, Sivertsen B, Scott J. 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. BMJ Open. 2021 Jun 28;11(6):e050661. doi: 10.1136/bmjopen-2021-050661.

  PMID: 34183350 DERIVED

MeSH Terms

Conditions

Mental Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Pål Sandvik, md

  St Olavs Hospital, Division of Mental Health Care

  STUDY DIRECTOR

• Håvard Kallestad, phd

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to their group allocation, but complete blinding is not possible as the participants may understand whether they have received the active or control condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: November 9, 2020
• Study Start: November 24, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

NO (4)