Psychophysiologic InsomniaSHUTiNorseNCT02261272
Internet-based Treatment for Insomnia
A study testing CBT for insomnia SHUTi and passive patient education/sleep hygiene in people with Psychophysiologic Insomnia, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
The study will test an internet-based treatment for insomnia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychophysiologic Insomnia
- What is being tested?
- CBT for insomnia SHUTi and passive patient education/sleep hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2013to Aug 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older
- fulfillment of the DMS-IV criteria for insomnia
- duration of at least 3 months
- complaints of impaired daytime functioning
Who cannot join
- presence of a major depressive disorder or other severe mental disorder as identified by in the telephone interview
- working night shifts and unable to discontinue this work pattern
- having a serious somatic condition preventing further participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Treatment for Insomnia in Norway.
The study will test an internet-based treatment for insomnia.
Read the detailed description
This study will develop and evaluate the feasibility of a cost-effective, more accessible alternative treatment approach for insomnia. Traditional CBT, including the behavioral, cognitive, and educational aspects, will be operationalized and transformed for an Internet intervention system, so individuals can access a personalized treatment any time, at their own convenience. Phase 1 of this study will involve developing the web program. The investigators research team and collaborators has extensive experience developing such web interventions, as well as considerable experience with insomnia. Phase 2 will be a large randomized controlled trial testing the Internet intervention compared to passive patient education/sleep hygiene. Two hundred individuals with insomnia will be assessed pre and post the six week treatment program. It is hypothesized that the Internet intervention will promote improvements in sleep, mood, and cognitive functioning. If successful, the current project may result in improved implementation of a low-threshold treatment for a common disorder with devastating impact on both individual and socioeconomic outcomes
- Conditions
- Psychophysiologic Insomnia
- Being tested
- CBT for insomnia SHUTi, passive patient education/sleep hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for insomnia SHUTiBehavioural
SHUTi
passive patient education/sleep hygieneBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CBT for insomnia | Experimental | Cognitive-behavioral therapy for insomnia Receives: Behavioral: CBT for insomnia SHUTi |
| Sleep Hygiene | Active comparator | Psychoeducational intervention based on standard sleep hygiene advices Receives: Behavioral: passive patient education/sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia symptoms
Self-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU
Measured: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
Secondary outcomes (2)
Daytime functioning (mental health problems and fatigue)
Self-reported questionnaires
Measured: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
Sleep diary data
Sleep duration, sleep onset latency and nocturnal wake time: change from baseline to post-treatment and FU
Measured: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychophysiologic InsomniaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Borge Sivertsen, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261272
- Sponsor's protocol ID
- SHUTiNorse
- Acronym
- SHUTiNorse
- Status last verified
- Sep 2016
- First submitted
- 1 Nov 2013
- Last updated
- 21 Sep 2016
- Results posted
- No
Publications
Lien M, Bredeli E, Sivertsen B, Kallestad H, Pallesen S, Smith ORF, Faaland P, Ritterband LM, Thorndike FP, Vedaa O. Short and long-term effects of unguided internet-based cognitive behavioral therapy for chronic insomnia in morning and evening persons: a post-hoc analysis. Chronobiol Int. 2019 Oct;36(10):1384-1398. doi: 10.1080/07420528.2019.1647435. Epub 2019 Aug 1.
PubMed 31368382Vedaa O, Hagatun S, Kallestad H, Pallesen S, Smith ORF, Thorndike FP, Ritterband LM, Sivertsen B. Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia. J Clin Sleep Med. 2019 Jan 15;15(1):101-110. doi: 10.5664/jcsm.7580.
PubMed 30621837Hagatun S, Vedaa O, Harvey AG, Nordgreen T, Smith ORF, Pallesen S, Havik OE, Thorndike FP, Ritterband LM, Sivertsen B. Internet-delivered cognitive-behavioral therapy for insomnia and comorbid symptoms. Internet Interv. 2018 Feb 21;12:11-15. doi: 10.1016/j.invent.2018.02.003. eCollection 2018 Jun.
PubMed 30135764
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Treatment for Insomnia in Norway.
- ClinicalTrials.gov ID
- NCT02261272
- Acronym / sponsor ID
- SHUTiNorse / SHUTiNorse
- Conditions
- Psychophysiologic Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Study start
- Nov 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Oct 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.
The study will test an internet-based treatment for insomnia.
Detailed description
This study will develop and evaluate the feasibility of a cost-effective, more accessible alternative treatment approach for insomnia. Traditional CBT, including the behavioral, cognitive, and educational aspects, will be operationalized and transformed for an Internet intervention system, so individuals can access a personalized treatment any time, at their own convenience. Phase 1 of this study will involve developing the web program. The investigators research team and collaborators has extensive experience developing such web interventions, as well as considerable experience with insomnia. Phase 2 will be a large randomized controlled trial testing the Internet intervention compared to passive patient education/sleep hygiene. Two hundred individuals with insomnia will be assessed pre and post the six week treatment program. It is hypothesized that the Internet intervention will promote improvements in sleep, mood, and cognitive functioning. If successful, the current project may result in improved implementation of a low-threshold treatment for a common disorder with devastating impact on both individual and socioeconomic outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT for insomnia | Experimental | Behavioral: CBT for insomnia SHUTiCognitive-behavioral therapy for insomnia |
| Sleep Hygiene | Active comparator | Behavioral: passive patient education/sleep hygienePsychoeducational intervention based on standard sleep hygiene advices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- fulfillment of the DMS-IV criteria for insomnia
- duration of at least 3 months
- complaints of impaired daytime functioning
Key exclusion criteria (3 listed)
- presence of a major depressive disorder or other severe mental disorder as identified by in the telephone interview
- working night shifts and unable to discontinue this work pattern
- having a serious somatic condition preventing further participation.
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 |
|---|---|---|
| CBT for insomnia SHUTiSHUTi | Behavioural | CBT for insomnia |
| passive patient education/sleep hygiene | Behavioural | Sleep Hygiene |
Primary outcome
Insomnia symptoms
Time frame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
Self-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU
2 secondary outcomes
Daytime functioning (mental health problems and fatigue)
Time frame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
Sleep diary data
Time frame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
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 21 Sep 2016.
- Derived from this study: PubMed 31368382Lien M, Bredeli E, Sivertsen B, Kallestad H, Pallesen S, Smith ORF, Faaland P, Ritterband LM, Thorndike FP, Vedaa O. Short and long-term effects of unguided internet-based cognitive behavioral therapy for chronic insomnia in morning and evening persons: a post-hoc analysis. Chronobiol Int. 2019 Oct;36(10):1384-1398. doi: 10.1080/07420528.2019.1647435. Epub 2019 Aug 1.
- Derived from this study: PubMed 30621837Vedaa O, Hagatun S, Kallestad H, Pallesen S, Smith ORF, Thorndike FP, Ritterband LM, Sivertsen B. Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia. J Clin Sleep Med. 2019 Jan 15;15(1):101-110. doi: 10.5664/jcsm.7580.
- Derived from this study: PubMed 30135764Hagatun S, Vedaa O, Harvey AG, Nordgreen T, Smith ORF, Pallesen S, Havik OE, Thorndike FP, Ritterband LM, Sivertsen B. Internet-delivered cognitive-behavioral therapy for insomnia and comorbid symptoms. Internet Interv. 2018 Feb 21;12:11-15. doi: 10.1016/j.invent.2018.02.003. eCollection 2018 Jun.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT for insomnia SHUTi and passive patient education/sleep hygiene in people with Psychophysiologic Insomnia, run by Norwegian Institute of Public Health 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 4 inclusion and 3 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 21 Sep 2016. 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 symptoms (time frame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU). 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 NCT02261272, which also lists 3 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 21 Sep 2016.