Clinical trial NCT02044263: Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet
Official title: Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Cognitive therapy
Behavior therapy
Waiting lists
Therapy, computer-assisted
Internet
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: insomnia severity
timeFrame: 6 months
measure: insomnia severity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Sleep Clinic, St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Håvard Kallestad, PhD PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.