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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044263
• Other study ID #: 2013/1836
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: November 2017

Study information

• Verified date: July 2020
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• face-to-face CBT-i

Locations

Country	Name	City	State
Norway	Sleep Clinic, St Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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 Trea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insomnia severity	as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)	6 months
Primary	insomnia severity	as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)	8 weeks