Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Noninferiority Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- insomnia severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
insomnia severity
Time Frame: 8 weeks
as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)
Secondary Outcomes
No secondary outcomes reported