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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02044263
Enrollment
101
Registered
2014-01-23
Start date
2014-07-31
Completion date
2017-11-30
Last updated
2020-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Cognitive therapy, Behavior therapy, Waiting lists, Therapy, computer-assisted, Internet

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.

Interventions

BEHAVIORALInternet 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.

Sponsors

St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
insomnia severity6 monthsas assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026