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

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: face-to-face CBT-i; Behavioral: Internet CBT-i SHUTi

• Registration Number: NCT02044263
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Study Start: 2014-07
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-06
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
insomnia severity	8 weeks	as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)

Trial Locations

Locations (1)

Sleep Clinic, St Olavs Hospital; 🇳🇴 Trondheim, Norway