InsomniaNORSE-3NCT02558647
Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I
A study testing CBT for insomnia (CBT-I) and Psycho-Education about Sleep (PE) in people with Insomnia, run by Norwegian Institute of Public Health at 2 sites in Norway.
Trial summary
Insomnia is a major public health concern. While cognitive behavior therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socio-economic benefits and its impact on health resource utilization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- CBT for insomnia (CBT-I) and Psycho-Education about Sleep (PE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesNorway
- Study dates
- Feb 2016to Dec 2021
- 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
- Individuals aged >=18 years who score >= 12 on the Insomnia Severity Index (a score indicative of insomnia symptoms that significantly impact on individuals)
- Willing and able to give online informed consent.
Who cannot join
- Individuals scoring >10 on the Epworth Sleepiness Scale (ESS) (which is suggestive of excessive daytime sleepiness) and/or answering that they usually or every day snore and stop breathing and have difficulties staying awake during the day (i.e., they positively endorse pre-selected indicators of sleep apnoea);
- Self-report of the presence of any medical conditions where a fully automated CBT-I may be contra-indicated (e.g. epilepsy, bipolar disorder, schizophrenia or psychotic disorders, and recent heart surgery)
- Participating in shift work.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Overcoming Insomnia: A Large-scale Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia Compared With Online Patient Education About Sleep.
Insomnia is a major public health concern. While cognitive behavior therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socio-economic benefits and its impact on health resource utilization. The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave, as well as medication and health resource utilization. Also, we will examine putative mediators and selected potential psycho-bio-social moderators of the effects of the intervention.
Read the detailed description
This is a two-arm RCT that assesses the benefits of online CBT-I compared with an alternative, active control intervention (online patient education about sleep (PE)). We will randomize 1500 individuals and collect follow-up data for up to two years. First, we will examine any differential change in the severity of insomnia, immediately after completing the interventions. Secondly, we will examine if there are differential changes in symptoms of physical and mental health (e.g. psychological distress, fatigue, and health related quality of life) immediately post-intervention, and whether any improvements in insomnia or other symptoms are reported at further follow-ups (6- and 24 months post treatment termination). Third, we will use national registry data collected routinely in Norway to compare rates of time off work due to sick leave days for up to two years before and after participating in the RCT, as well as monitoring medication and health resource utilization according to condition in the same time interval. Fourth, we will try to extend the knowledge base about online interventions by undertaking exploratory analyses to assess whether change in specific clinical variables (e.g. sleep variability, psychological measures of beliefs about sleep) mediate the effects of the CBT-I intervention. Lastly, (subject to additional funding to collect saliva samples), we will examine a subset of psycho-bio-social factors to try to identify potential treatment moderators that might inform the stratification of individuals with insomnia into 'treatment-relevant' subgroups in the future (e.g. this may include also an exploration of 'therapygenetics').
- Conditions
- Insomnia
- Being tested
- CBT for insomnia (CBT-I), Psycho-Education about Sleep (PE)
- Keywords
- therapy, CBT-I, internet-based, online, short-term benefits, medium-term outcomes, health resource use, sick leave
- 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.
CBT for insomnia (CBT-I)Behavioural
Also called SHUTi
CBT-I is an online, fully automated, interactive, and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention.
Psycho-Education about Sleep (PE)Behavioural
Also called passive education/ sleep hygeine
PE provides online information about insomnia symptoms; the impact, prevalence, and causes of insomnia; when to seek input from a doctor; and basic lifestyle, environmental, and behavioral strategies that may help to improve sleep.
| Study group | Role | What they receive |
|---|---|---|
| CBT for insomnia (CBT-I) | Experimental | Internet-based cognitive-behavioral therapy for insomnia (CBT-I) comprises a fully automated, interactive, and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention Receives: Behavioral: CBT for insomnia (CBT-I) |
| Psychoeducation about Sleep (PE) | Active comparator | The PE intervention gives participants access to a website with information about insomnia symptoms; the impact, prevalence, and causes of insomnia; when to seek input from a doctor; and basic lifestyle, environmental, and behavioral strategies that may help to improve sleep. Receives: Behavioral: Psycho-Education about Sleep (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index, ISI
The ISI will be used to assess self-reported levels of insomnia severity. Range is 0-28. Higher values represent higher levels of insomnia symptom severity.
Measured: Pre to 9 weeks post randomization (post treatment assessment)
Secondary outcomes (26)
Insomnia Severity Index, ISI
The ISI will be used to assess self-reported levels of insomnia severity. Range is 0-28. Higher values represent higher levels of insomnia symptom severity.
Measured: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Sleep diaries
Sleep diaries will be used to get daily information about: Sleep duration, sleep onset latency, wake after sleep onset, number of awakenings, bed time, rise time, time for final awakening before rise time, medication used, alchohol/drug use, variability. Individuals keep a record for at least 10 of 14 consecutive days.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Hospital Anxiety and Depression Scale, HADS
The HADS will be used to assess levels of anxiety and depression. The HADS comprises 14 items (higher values indicate higher symptom severity) pertaining to non-vegetative symptoms of anxiety and depression, which makes it a suitable measure of general psychological distress in populations likely to have physical comorbidities (e.g. general practice and liaison psychiatry settings).
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Short Form-12, SF-12
The SF-12 is an abbreviated version of the MOS 36-item short-form health survey (SF-36), and measures the individuals' perceived physical and mental health status. The SF-12 is scored using the recommended MOS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as T-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Dysfunctional Beliefs About Sleep scale, DBAS
The DBAS is a self-report questionnaire designed to identify maladaptive sleep- and insomnia-related cognitions. Patients are given a list of 16 statements reflecting different beliefs and attitudes about sleep, and they are asked to indicate on a 10-point scale how much they agree with the statements. Higher scores indicate higher levels of endorsement of beliefs.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Chalder Fatigue Questionnaire, CFQ
The CFQ comprises 11 items addressing physical and psychological fatigue, and two items addressing the duration and the intensity of fatigue complaints. Higher values indicate higher levels of fatigue.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
The Bergen Insomnia Scale, BIS
The BIS comprises six items that assesses symptoms of insomnia based on the insomnia criteria found in the Diagnostic and Statistical Manual of Mental Disorders-IV-TR (American Psychiatric Association). Higher values indicate higher levels of insomnia severity.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Brief Horne-Östberg Morningness-Eveningness Questionnaire, MEQ
The MEQ is the most widely used measure of chronotype (so-called 'morningness' or 'eveningness'), and gives an indication of the respondents preferred (as opposed to actual) rise-time and bed-time. Higher scores indicate higher levels of morningness.
Measured: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Physical health
A 20-item checklist of common medical conditions and any impact on work or personal life. Also used in the Helseundersøkelsen Nordtrøndelag study (the HUNT study).
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Mental health
Presence of psychiatric conditions will be assessed with an 8-item checklist of common psychiatric conditions based on a template used for physical health in the Helseundersøkelsen Nordtrøndelag study (the HUNT study).
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Pain site
A self-report checklist (yes/no) of nine sites on the body where one can experience pain.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Alcohol use disorders identification test - consumption , AUDIT-C
The AUDIT-C scale comprises of three items and will be used to assess the frequency and quantity of alcohol consumption where higher scores indicate higher levels of use.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Body Mass Index
Height will be recorded at baseline and weight will be recorded at baseline, post-intervention, 6 and 24 months to allow estimation of body mass index (kg/m^2) at these time points.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Physical activity
Level of self-reported physical activity is measured using six items (from the HUNT study) that assess frequency, intensity and duration of the activity.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
National Insurance Administration (NIA)
Objective data on days with sick leave will be determined with data from the NIA, a national Norwegian registry which records all periods of sick leave >13 days, as well as information on all disability pension awards.
Measured: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization
Norwegian Patient Registry (NPR)
Objective data on the use and type of specialist health care services will be determined using the NPR, a national Norwegian registry which contains information about all patients who are waiting for, or have received treatment, as outpatients in the specialist health service. The data retrieved from the NPR include diagnoses (according to ICD-10 criteria), name of health care provider, service use (e.g. outpatient appointments) and hospital admission and discharge dates.
Measured: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization
Norwegian Prescription Database (NorPD)
Medication use will be determined from NorPD, a national health register comprising information on all prescriptions dispensed at Norwegian pharmacies (since January 2004). The NorPD provides detailed information that will allow us to identify the medication, its class, and information on dispensed prescriptions (which can be used as a proxy for medication consumption).
Measured: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization
Help seeking behavior
A self-report 10-item questionnaire that records what help or treatments that have been sought.
Measured: 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Medication use
Free text where participants report reason for medication use, dosage, timing, and adherence.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Use of health care services
Subjective reports of health care service use will be assessed with 5 items recording use of primary and secondary health services.
Measured: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Absence from work and loss of productivity
A self-report 7 item questionnaire that assess absence from work and loss of productivity due to health problems.
Measured: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Impact of health problems on productivity
2 items recording self-perceptions of any negative effects of health status on work or leisure activities.
Measured: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Internet intervention evaluation
The acceptability of online interventions after completion of the programs will be assessed with the Internet intervention evaluation which comprises two questionnaires used in SHUTi research: the Internet Intervention Utility Questionnaire (UQ) and the Internet Intervention Impact Questionnaire (IQ).
Measured: 9 weeks after randomization (post assessment), and 24 months follow-up (24 months and 9 weeks after randomization)
Electronic Media Use
Self-report ratings of how much daily time participants spend, and how much time they spend while in bed, on different five different types of electronic media.
Measured: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Negative Effects Questionnaire, NEQ
To assess views regarding the interventions, we will ask participants to complete the NEQ. The NEQ is a self-report measure that contains 32 items that are scored on a five point Likert-scale (0-4) where higher scores indicate higher levels of negative effects. After each item, the individual is asked whether they consider the effect to be caused by the treatment received or caused by other circumstances (yes/no), as well as one open-ended question.
Measured: 24 months follow-up (24 months and 9 weeks after randomization)
Use of sleep strategies questionnaire
A self-report questionnaire has been developed in order to assess patients continued use of sleep strategies after the intervention. The questionnaire comprises 6 items assessing how many times each week the last month patients have used 6 different therapeutic techniques used in Cognitive Behavior Therapy for Insomnia (incl. kept a stable rise time, refrained from sleeping during daytime, used the bed and the bedroom only for sleeping, practiced sleep restriction, got out of the bed when unable to fall asleep within 15-20 minutes, and kept a sleep diary), how useful each technique was on a 0 to 10 scale where higher score indicates higher level of usefulness, and whether the patients have used the technique regularly since terminating treatment (yes/no).
Measured: 24 months follow-up (24 months and 9 weeks after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startFeb 2016
- Primary completionOct 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- This is a parallel-group superiority RCT comparing internet-delivered CBT-I (a Norwegian language version of SHUTi) with online patient education about sleep (PE).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Principal investigator, Borge Sivertsen, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558647
- Sponsor's protocol ID
- NFR:239985
- Other IDs
- HUNT-SHUTi
- Acronym
- NORSE-3
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2015
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Vethe D, Khan ZA, Vestergaard CL, Halsteinli V, Saksvik SB, Vedaa O, Sivertsen B, Morken G, Langsrud K, Ritterband LM, Robert F Smith O, Scott J, Kallestad H. Long-term clinical and cost-effectiveness of a fully automated digital cognitive behavioural therapy for insomnia: 2-year follow-up of a single-blind, superiority, randomised controlled trial. Lancet Reg Health Eur. 2026 May 8;66:101691. doi: 10.1016/j.lanepe.2026.101691. eCollection 2026 Jul.
PubMed 42164344Skoglund H, Sivertsen B, Kallestad H, Vedaa O. Digital cognitive behavioral therapy for insomnia for people with comorbid psychological distress: A large scale randomized controlled trial. Sleep Med. 2024 Sep;121:241-250. doi: 10.1016/j.sleep.2024.06.026. Epub 2024 Jun 28.
PubMed 39024778Vestergaard CL, Vedaa O, Simpson MR, Faaland P, Vethe D, Kjorstad K, Langsrud K, Ritterband LM, Sivertsen B, Stiles TC, Scott J, Kallestad H. The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. Sleep. 2021 Oct 11;44(10):zsab118. doi: 10.1093/sleep/zsab118.
PubMed 33964166Vedaa O, Kallestad H, Scott J, Smith ORF, Pallesen S, Morken G, Langsrud K, Gehrman P, Thorndike FP, Ritterband LM, Harvey AG, Stiles T, Sivertsen B. Effects of digital cognitive behavioural therapy for insomnia on insomnia severity: a large-scale randomised controlled trial. Lancet Digit Health. 2020 Aug;2(8):e397-e406. doi: 10.1016/S2589-7500(20)30135-7.
PubMed 33328044Kallestad H, Vedaa O, Scott J, Morken G, Pallesen S, Harvey AG, Gehrman P, Thorndike F, Ritterband L, Stiles TC, Sivertsen B. Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep. BMJ Open. 2018 Aug 30;8(8):e025152. doi: 10.1136/bmjopen-2018-025152.
PubMed 30166311
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Insomnia: A Large-scale Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia Compared With Online Patient Education About Sleep.
- ClinicalTrials.gov ID
- NCT02558647
- Acronym / sponsor ID
- NORSE-3 / NFR:239985
- Conditions
- Insomnia
- Keywords
- therapy, CBT-I, internet-based, online, short-term benefits, medium-term outcomes, health resource use, sick leave
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Sep 2015 (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.
Insomnia is a major public health concern. While cognitive behavior therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socio-economic benefits and its impact on health resource utilization. The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave, as well as medication and health resource utilization. Also, we will examine putative mediators and selected potential psycho-bio-social moderators of the effects of the intervention.
Detailed description
This is a two-arm RCT that assesses the benefits of online CBT-I compared with an alternative, active control intervention (online patient education about sleep (PE)). We will randomize 1500 individuals and collect follow-up data for up to two years. First, we will examine any differential change in the severity of insomnia, immediately after completing the interventions. Secondly, we will examine if there are differential changes in symptoms of physical and mental health (e.g. psychological distress, fatigue, and health related quality of life) immediately post-intervention, and whether any improvements in insomnia or other symptoms are reported at further follow-ups (6- and 24 months post treatment termination). Third, we will use national registry data collected routinely in Norway to compare rates of time off work due to sick leave days for up to two years before and after participating in the RCT, as well as monitoring medication and health resource utilization according to condition in the same time interval. Fourth, we will try to extend the knowledge base about online interventions by undertaking exploratory analyses to assess whether change in specific clinical variables (e.g. sleep variability, psychological measures of beliefs about sleep) mediate the effects of the CBT-I intervention. Lastly, (subject to additional funding to collect saliva samples), we will examine a subset of psycho-bio-social factors to try to identify potential treatment moderators that might inform the stratification of individuals with insomnia into 'treatment-relevant' subgroups in the future (e.g. this may include also an exploration of 'therapygenetics').
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a parallel-group superiority RCT comparing internet-delivered CBT-I (a Norwegian language version of SHUTi) with online patient education about sleep (PE).
| Arm | Type | Receives |
|---|---|---|
| CBT for insomnia (CBT-I) | Experimental | Behavioral: CBT for insomnia (CBT-I)Internet-based cognitive-behavioral therapy for insomnia (CBT-I) comprises a fully automated, interactive, and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention |
| Psychoeducation about Sleep (PE) | Active comparator | Behavioral: Psycho-Education about Sleep (PE)The PE intervention gives participants access to a website with information about insomnia symptoms; the impact, prevalence, and causes of insomnia; when to seek input from a doctor; and basic lifestyle, environmental, and behavioral strategies that may help to improve sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals aged >=18 years who score >= 12 on the Insomnia Severity Index (a score indicative of insomnia symptoms that significantly impact on individuals)
- Willing and able to give online informed consent.
Key exclusion criteria (3 listed)
- Individuals scoring >10 on the Epworth Sleepiness Scale (ESS) (which is suggestive of excessive daytime sleepiness) and/or answering that they usually or every day snore and stop breathing and have difficulties staying awake during the day (i.e., they positively endorse pre-selected indicators of sleep apnoea);
- Self-report of the presence of any medical conditions where a fully automated CBT-I may be contra-indicated (e.g. epilepsy, bipolar disorder, schizophrenia or psychotic disorders, and recent heart surgery)
- Participating in shift work.
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 (CBT-I)Also: SHUTiCBT-I is an online, fully automated, interactive, and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. | Behavioural | CBT for insomnia (CBT-I) |
| Psycho-Education about Sleep (PE)Also: passive education/ sleep hygeinePE provides online information about insomnia symptoms; the impact, prevalence, and causes of insomnia; when to seek input from a doctor; and basic lifestyle, environmental, and behavioral strategies that may help to improve sleep. | Behavioural | Psychoeducation about Sleep (PE) |
Primary outcome
Insomnia Severity Index, ISI
Time frame: Pre to 9 weeks post randomization (post treatment assessment)
The ISI will be used to assess self-reported levels of insomnia severity. Range is 0-28. Higher values represent higher levels of insomnia symptom severity.
26 secondary outcomes
Insomnia Severity Index, ISI
Time frame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Sleep diaries
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Hospital Anxiety and Depression Scale, HADS
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Short Form-12, SF-12
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Dysfunctional Beliefs About Sleep scale, DBAS
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Chalder Fatigue Questionnaire, CFQ
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
The Bergen Insomnia Scale, BIS
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Brief Horne-Östberg Morningness-Eveningness Questionnaire, MEQ
Time frame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Physical health
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Mental health
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Pain site
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Alcohol use disorders identification test - consumption , AUDIT-C
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Body Mass Index
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Physical activity
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
National Insurance Administration (NIA)
Time frame: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization
Norwegian Patient Registry (NPR)
Time frame: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization
Norwegian Prescription Database (NorPD)
Time frame: Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization
Help seeking behavior
Time frame: 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Medication use
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Use of health care services
Time frame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Absence from work and loss of productivity
Time frame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Impact of health problems on productivity
Time frame: Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Internet intervention evaluation
Time frame: 9 weeks after randomization (post assessment), and 24 months follow-up (24 months and 9 weeks after randomization)
Electronic Media Use
Time frame: Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization)
Negative Effects Questionnaire, NEQ
Time frame: 24 months follow-up (24 months and 9 weeks after randomization)
Use of sleep strategies questionnaire
Time frame: 24 months follow-up (24 months and 9 weeks after randomization)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Derived from this study: PubMed 42164344Vethe D, Khan ZA, Vestergaard CL, Halsteinli V, Saksvik SB, Vedaa O, Sivertsen B, Morken G, Langsrud K, Ritterband LM, Robert F Smith O, Scott J, Kallestad H. Long-term clinical and cost-effectiveness of a fully automated digital cognitive behavioural therapy for insomnia: 2-year follow-up of a single-blind, superiority, randomised controlled trial. Lancet Reg Health Eur. 2026 May 8;66:101691. doi: 10.1016/j.lanepe.2026.101691. eCollection 2026 Jul.
- Derived from this study: PubMed 39024778Skoglund H, Sivertsen B, Kallestad H, Vedaa O. Digital cognitive behavioral therapy for insomnia for people with comorbid psychological distress: A large scale randomized controlled trial. Sleep Med. 2024 Sep;121:241-250. doi: 10.1016/j.sleep.2024.06.026. Epub 2024 Jun 28.
- Derived from this study: PubMed 33964166Vestergaard CL, Vedaa O, Simpson MR, Faaland P, Vethe D, Kjorstad K, Langsrud K, Ritterband LM, Sivertsen B, Stiles TC, Scott J, Kallestad H. The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. Sleep. 2021 Oct 11;44(10):zsab118. doi: 10.1093/sleep/zsab118.
- Derived from this study: PubMed 33328044Vedaa O, Kallestad H, Scott J, Smith ORF, Pallesen S, Morken G, Langsrud K, Gehrman P, Thorndike FP, Ritterband LM, Harvey AG, Stiles T, Sivertsen B. Effects of digital cognitive behavioural therapy for insomnia on insomnia severity: a large-scale randomised controlled trial. Lancet Digit Health. 2020 Aug;2(8):e397-e406. doi: 10.1016/S2589-7500(20)30135-7.
- Derived from this study: PubMed 30166311Kallestad H, Vedaa O, Scott J, Morken G, Pallesen S, Harvey AG, Gehrman P, Thorndike F, Ritterband L, Stiles TC, Sivertsen B. Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep. BMJ Open. 2018 Aug 30;8(8):e025152. doi: 10.1136/bmjopen-2018-025152.
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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.
2 sites 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 (CBT-I) and Psycho-Education about Sleep (PE) in people with Insomnia, run by Norwegian Institute of Public Health at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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 Index, ISI (time frame: Pre to 9 weeks post randomization (post treatment assessment)). 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 NCT02558647, which also lists 5 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 4 Sep 2019.