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

Primary Purpose

Insomnia

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Internet CBT-i SHUTi

face-to-face CBT-i

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Cognitive therapy, Behavior therapy, Waiting lists, Therapy, computer-assisted, Internet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sleep Clinic, St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internet CBT-i

face-to-face CBT-i

Arm Description

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

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

Outcomes

Primary Outcome Measures

insomnia severity

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

insomnia severity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02044263

First Posted

January 21, 2014

Last Updated

July 6, 2020

Sponsor

St. Olavs Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02044263

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

July 2014 (Actual)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet CBT-i

Arm Type

Experimental

Arm Description

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

Arm Title

face-to-face CBT-i

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Internet CBT-i SHUTi

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

face-to-face CBT-i

Primary Outcome Measure Information:

Title

insomnia severity

Description

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

Time Frame

6 months

Title

insomnia severity

Description

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Håvard Kallestad, PhD PsyD

Organizational Affiliation

St. Olavs Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sleep Clinic, St Olavs Hospital

City

Trondheim

Country

Norway

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

result

PubMed Identifier

34291808

Citation

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.

Results Reference

derived

Learn more about this trial

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

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