InsomniaNCT02044263
Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet
A study testing Internet CBT-i SHUTi and face-to-face CBT-i in people with Insomnia, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Internet CBT-i SHUTi and face-to-face CBT-i
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for insomnia disorder
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Noninferiority Trial
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.
- Conditions
- Insomnia
- Being tested
- Internet CBT-i SHUTi, face-to-face CBT-i
- Keywords
- Cognitive therapy, Behavior therapy, Waiting lists, Therapy, computer-assisted, Internet
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet CBT-i SHUTiBehavioural
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-iBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Behavioral: face-to-face CBT-i |
What is being measured
The primary outcome is the main question the study is designed to answer.
insomnia severity
as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)
Measured: 6 months
insomnia severity
as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Håvard Kallestad, PhD PsyD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044263
- Sponsor's protocol ID
- 2013/1836
- Status last verified
- Jul 2020
- First submitted
- 21 Jan 2014
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
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.
PubMed 34291808
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Noninferiority Trial
- ClinicalTrials.gov ID
- NCT02044263
- Acronym / sponsor ID
- 2013/1836
- Conditions
- Insomnia
- Keywords
- Cognitive therapy, Behavior therapy, Waiting lists, Therapy, computer-assisted, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet CBT-i | Experimental | Behavioral: Internet CBT-i SHUTiParticipants will be instructed on the use of the internet CBT-i (SHUTi) intervention site, then use the program for six weeks. |
| face-to-face CBT-i | Active comparator | Behavioral: face-to-face CBT-i4 to 8 sessions of face-to-face CBT-i treatment with one of three clinicians (experienced CBT-i psychiatrists) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for insomnia disorder
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet CBT-i SHUTiComputer 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. | Behavioural | Internet CBT-i |
| face-to-face CBT-i | Behavioural | face-to-face CBT-i |
Primary outcome
insomnia severity
Time frame: 6 months
as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)
insomnia severity
Time frame: 8 weeks
as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Results publicationH 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
- Derived from this study: PubMed 34291808Kallestad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håvard Kallestad, PhD PsyD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet CBT-i SHUTi and face-to-face CBT-i in people with Insomnia, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insomnia severity (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02044263, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.