NCT02044263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

January 21, 2014

Last Update Submit

July 6, 2020

Conditions

Insomnia

Keywords

Cognitive therapyBehavior therapyWaiting listsTherapy, computer-assistedInternet

Outcome Measures

Primary Outcomes (2)

  • insomnia severity

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

    6 months

  • insomnia severity

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

    8 weeks

Study Arms (2)

Internet CBT-i

EXPERIMENTAL

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

Behavioral: Internet CBT-i SHUTi

face-to-face CBT-i

ACTIVE COMPARATOR

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

Behavioral: face-to-face CBT-i

Interventions

Internet CBT-i SHUTiBEHAVIORAL

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.

Internet CBT-i
face-to-face CBT-iBEHAVIORAL
face-to-face CBT-i

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for insomnia disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Clinic, St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

  • 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

    RESULT

  • 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.

    PMID: 34291808DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Håvard Kallestad, PhD PsyD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 23, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations

NO(1)