Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet

NCT ID: NCT02044263

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-11-30

Brief Summary

Background: Insomnia is a highly prevalent and disabling disorder where Cognitive Behavior Therapy for Insomnia (CBT-I) is established as the best available treatment. Still, only a negligible number of patients with insomnia receive this treatment. One potential way of improving the dissemination of CBT-I is by using online adaptations of CBT-I. This is a new method for delivering CBT-I and it is not known how effective online treatment is compared to face-to-face CBT-I. This trial's purpose is to compare face-to-face CBT-I with online CBT-I. Because of the great advantage of online treatment in both availability and cost, the trial is designed as a noninferiority trial.

Aim: To test if online CBT-I is noninferior in reducing insomnia complaints compared with CBT-I as delivered face-to-face by a therapist.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet CBT-i

Participants will be instructed on the use of the internet CBT-i (SHUTi) intervention site, then use the program for six weeks.

Group Type: EXPERIMENTAL

Internet CBT-i SHUTi

Intervention Type: BEHAVIORAL

Computer program SHUTi is based on the same theoretical model of insomnia and involves the same interventions as ordinary CBT-I: a structured treatment focusing on education, behaviors and cognitions. Specifically, CBT-I usually consists of one or more of the following: psychoeducation about sleep, sleep restriction therapy, stimulus control, relaxation techniques, and challenging beliefs and perception of sleep.

face-to-face CBT-i

4 to 8 sessions of face-to-face CBT-i treatment with one of three clinicians (experienced CBT-i psychiatrists)

Group Type: ACTIVE_COMPARATOR

face-to-face CBT-i

Intervention Type: BEHAVIORAL

Interventions

Internet CBT-i SHUTi

Computer program SHUTi is based on the same theoretical model of insomnia and involves the same interventions as ordinary CBT-I: a structured treatment focusing on education, behaviors and cognitions. Specifically, CBT-I usually consists of one or more of the following: psychoeducation about sleep, sleep restriction therapy, stimulus control, relaxation techniques, and challenging beliefs and perception of sleep.

Intervention Type: BEHAVIORAL

face-to-face CBT-i

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for insomnia disorder

Exclusion Criteria

• a condition that renders the patient incapable of understanding the treatment (e.g. actively psychotic, mental retardation, dementia or others
• an ongoing substance abuse problem
• other organic sleep disturbances or circadian sleep disturbance
• an ongoing medical condition where treatment of insomnia is not indicated (e.g. an attack phase of multiple sclerosis)
• working night shifts and being unable to discontinue this work pattern
• not being sufficiently fluent in Norwegian to understand the assessments or treatment
• not having the necessary computer skills needed to log on to the web based program

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Håvard Kallestad, PhD PsyD

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

Sleep Clinic, St Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

H Kallestad, K Langsrud, Ø Vedaa, T Stiles, D Vethe, S Lydersen, L Ritterband, G Morken, B Sivertsen. A Randomized Noninferiority Trial Comparing Cognitive Behavior Therapy For Insomnia (cbt-i) Delivered By A Therapist Or Via A Fully Automated Online Treatment Program. Sleep, Volume 41, Issue suppl_1, April 2018, Page A142 https://doi.org/10.1093/sleep/zsy061.370

Reference Type: RESULT

Kallestad H, Scott J, Vedaa O, Lydersen S, Vethe D, Morken G, Stiles TC, Sivertsen B, Langsrud K. Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy. Sleep. 2021 Dec 10;44(12):zsab185. doi: 10.1093/sleep/zsab185.

Reference Type: DERIVED

PMID: 34291808 (View on PubMed)

Other Identifiers

2013/1836

Identifier Type: -

Identifier Source: org_study_id