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

N/ACompletedNCT02044263

St. Olavs Hospital101 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Insomnia

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)

Time frame: 6 months