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OpenTrials
Completed

NCT Number: NCT02044263

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Clinic, St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet CBT-i SHUTi

Behavioral

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.

Face-to-Face CBT-I

Behavioral

Primary outcomes

  1. insomnia severity

    Time frame: 6 months

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

  2. insomnia severity

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Official study title

Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Noninferiority Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2014
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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