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

Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Noninferiority Trial

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Internet CBT-i SHUTi; Behavioral: face-to-face CBT-i

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Sleep Clinic, St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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)	Behavioral: face-to-face CBT-i

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insomnia severity	as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)	6 months
insomnia severity	as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)	8 weeks

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Investigators: Principal Investigator: Håvard Kallestad, PhD PsyD, St. Olavs Hospital

Publications and helpful links

General Publications

• 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
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Cognitive therapy; Internet; Therapy, computer-assisted; Behavior therapy; Waiting lists
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2013/1836

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No