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

St. Olavs Hospital

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Internet CBT-i SHUTi; Behavioral: face-to-face CBT-i

Study type: Interventional

Funder types: Other

Identifiers

NCT02044263

2013/1836

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Internet CBT-i

Experimental group

Description:

Participants will be instructed on the use of the internet CBT-i (SHUTi) intervention site, then use the program for six weeks.

Treatment:

Behavioral: Internet CBT-i SHUTi

face-to-face CBT-i

Active Comparator group

Description:

4 to 8 sessions of face-to-face CBT-i treatment with one of three clinicians (experienced CBT-i psychiatrists)

Treatment:

Behavioral: face-to-face CBT-i