Mental DisorderNorse4NCT04621643
Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in Individuals Referred to Public Mental Health Services in Norway
A study testing digital cognitive behavioral therapy (dCBT-I) and Digital patient education about insomnia (PE) in people with Mental Disorder and Insomnia, run by St. Olavs Hospital at 4 sites in Norway.
Trial summary
Sleep is a fundamental human need with large impact on both psychological and somatic functioning. However, for patients with mental disorders, sleep is often disturbed. Across all diagnostic groups, sleep disturbance is one of the most common and disruptive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder, Insomnia
- What is being tested?
- digital cognitive behavioral therapy (dCBT-I) and Digital patient education about insomnia (PE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 911 participants
- Where
- 4 sitesNorway
- Study dates
- 24 Nov 2020to 30 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent.
- Insomnia Severity Index (ISI) > 11 We have used this cut-off score previously to identify individuals who are likely to be experiencing clinical significant insomnia and who will potentially benefit from the dCBT-I intervention. Kallestad et al 2018 and a trial from Norway (Filosa et al in press) suggest that this cut-off is the most sensitive to detect a diagnosis of Insomnia Disorder.
Who cannot join
- Sleep apnea screening: Positive endorsement of a screening question for sleep apnea (the item asks if they "usually or everyday snore and stop breathing and have difficulties staying awake during the day")
- Medical history indicative of (i) epilepsy plus self-report of >=1 seizure <12 months ago, or (ii) recent surgery for heart disease, or (iii) currently in an attack phase of multiple sclerosis.
- Individuals whose work schedule includes night shifts.
- Pregnancy
- Inadequate opportunity to sleep or circumstances prevent modification of sleep pattern (e.g. having a child aged<12 months residing home).
- Currently receiving psychological treatment for insomnia.
- Not a patient at one of the participating clinics.
- Not having completed baseline assessment
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Helse Møre og Romsdal HF
Ålesund
AHUS
Oslo
Stavanger Universitetssykehus
Stavanger
St Olavs Hospital
Trondheim
About this study
Official title: A Multi-center Randomized Controlled Trial of Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in Individuals Referred to Secondary Mental Health Services in Norway
Sleep is a fundamental human need with large impact on both psychological and somatic functioning. However, for patients with mental disorders, sleep is often disturbed. Across all diagnostic groups, sleep disturbance is one of the most common and disruptive symptoms. For decades it has been assumed that the sleep disturbance these patients experience was a secondary symptom of a primary mental disorder, but recently this has changed. Experimental and clinical data now suggest that there is a reciprocal relationship between sleep disturbance and mental disorders where they perpetuate and aggravate each other. This makes sleep disturbance a potential therapeutic target in the treatment of mental disorders. Evidence emerging the last decade indicate that providing Cognitive Behavior Therapy for Insomnia (CBT-I) to patients with mental disorders not only improves sleep, but also has clinically meaningful effects on their primary mental disorder. However, a major problem has been disseminating CBT-I and few therapists are trained in this intervention. Consequently, most patients receive sleep medication although evidence clearly indicate that CBT-I is more effective and should be the treatment of choice. In this study, the investigators will use a fully automated digital version of CBT-I that might be used to treat a large number of patients while they are still on the waiting list to receive ordinary outpatient treatment in secondary mental health care clinics in Norway. The main goal is to test the effectiveness of digital CBT-I for this patient group.
Read the detailed description
(27th May 2021) We have revised one of the study exclusion criteria. In the initial protocol we reported that we would exclude individuals with clinical evidence of sleep apnea, namely, we stated that: "Sleep apnea screening: An Epworth Sleepiness Scale (ESS) score >=13, indicative of high levels of objective daytime sleepiness associated with organic sleep disorders and/or positive endorsement of a screening question for sleep apnea (the item asks if they "usually or everyday snore and stop breathing and have difficulties staying awake during the day")." We have now modified the exclusion criterion, so that it is based on the screening question alone. Our updated exclusion criterion is now stated as follows: "Sleep apnea screening: A positive endorsement of a screening question for sleep apnea (the item asks if they "usually or everyday snore and stop breathing and have difficulties staying awake during the day")." i.e. the ESS score is no longer part of the assessment for eligibility for inclusion. The rationale for this change is that several publications and international experts have questioned the reliability and validity of the ESS cut-off score (>=13) when the scale is used in psychiatric outpatient populations (psychometrics in clinical samples are only modest when compared with ESS for screening community-based and/or non-clinical samples). As such ESS score is no longer used as an exclusion criterion, but we will continue to collect these data at baseline assessment and will report the ESS scores for the recruited sample.
At the time of making the amendment, 29 participants had been excluded on the basis of the ESS score.
(27th Feb, 2023): In the protocol that was approved by the Regional Committees for Medical and Health Research Ethics before inclusion started, under 'sample size', we wrote: "As the planned RCT involves limited contact between researchers and participants and has a 12-month follow-up, we have predicted that the study dropout rate is likely to reach about 50%. Therefore, we aim to recruit 800 participants, to enable us to retain 400 patients (200 in each treatment arm) at the end of the RCT."
We have now included 790 participants in this trial, and the attrition rate at the 12 month follow-up assessment is somewhat higher than predicted before we started the trial. Currently, 46% of the participants have completed the 12 month follow-up assessment. Based on this, we will not reach the target of retaining 400 participants at the end of the RCT with a sample size of 800 participants.
We have described the situation to the Regional Committees for Medical and Health Research Ethics. They have approved inclusion of new participants until June 30th 2023. This has been presented to the leaderships of the participating centers who also have approved inclusion until June 30th 2023. We will therefore recruit participants until this date. Based on our projections we will have retained at least 404 participants at the end of the RCT at this date.
- Conditions
- Mental Disorder, Insomnia
- Being tested
- digital cognitive behavioral therapy (dCBT-I), Digital patient education about insomnia (PE)
- Keywords
- Cognitive Behavioral Therapy, Patient Education, Telemedicine, Waiting Lists
- Medical subject headings
- Mental Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital cognitive behavioral therapy (dCBT-I)Behavioural
dCBT-I during 9 weeks. Multicomponent intervention that includes the following: psychoeducation about sleep, sleep hygiene, sleep restriction therapy, stimulus control and challenging beliefs and perception about sleep. The digital CBT-I that will be utilized in this study is named Sleep Healthy Using The internet (SHUTi). The intervention is fully automated with no contact with health care personnel, it is interactive and adapts to input from the users. It comprises of the same elements included in face-to-face CBT-I, but the user gains access to a new educational, behavioral or cognitive module each week only after completion of digital sleep diaries. dCBT-I can be accessed on computers or hand-held devices
Digital patient education about insomnia (PE)Behavioural
Control condition PE during 9 weeks. A digital patient education program that can be accessed on computers or hand-held devices. The information overlaps with that included in the dCBT-I intervention but it does not include any of the interactive features of the dCBT-I intervention and all the information is available from the moment the PE site is opened.
| Study group | Role | What they receive |
|---|---|---|
| digital cognitive behavioral therapy (dCBT-I) | Experimental | Not described Receives: Behavioral: digital cognitive behavioral therapy (dCBT-I) |
| Patient education about sleep (PE) | Active comparator | Not described Receives: Behavioral: Digital patient education about insomnia (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in insomnia severity at week 9 after randomization
Assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Measured: 9 weeks after randomization
Secondary outcomes (48)
Between-group difference in insomnia severity at week 33 after randomization
While between-group difference on the ISI on week 9 is our primary endpoint, we will also assess between group differences on the ISI at week 33 (six months after post-assessment) and week 61 (one year after post assessment). Assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Measured: 33 weeks after randomization
Between-group difference in insomnia severity at week 61 after randomization
While between-group difference on the ISI on week 9 is our primary endpoint, we will also assess between group differences on the ISI at week 33 (six months after post-assessment) and week 61 (one year after post assessment). Assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
Measured: 61 weeks after randomization
Prospective daily sleep-wake pattern at week 9 after randomization
Assessed with the Consensus Sleep Dairy, which will be completed by the participant at baseline and each follow-up point for at least 10 out of 14 consecutive days.
Measured: 9 weeks after randomization
Prospective daily sleep-wake pattern at week 33 after randomization
Assessed with the Consensus Sleep Dairy, which will be completed by the participant at baseline and each follow-up point for at least 10 out of 14 consecutive days.
Measured: 33 weeks after randomization
Prospective daily sleep-wake pattern at week 61 after randomization
Assessed with the Consensus Sleep Dairy, which will be completed by the participant at baseline and each follow-up point for at least 10 out of 14 consecutive days.
Measured: 61 weeks after randomization
Chronotype at week 9 after randomization
Assessed with the Reduced Morningness - Eveningness Questionnaire (rMEQ), a widely used measure of chronotype i.e. time preference for daily activities, including bed-times. The rMEQ has five items yielding scores from 4 to 25, with lower scores indicating "eveningness" and higher scores indicating "morningness". Higher scores indicate higher levels of morningness. Scores can be divided into five categories: definitely evening type (score <8), moderately evening type (Score 8-11), neither type (score 12-17), moderately evening type (score 18-21), and definitely morning type (score >21)
Measured: 9 weeks after randomization
Chronotype at week 33 after randomization
Assessed with the Reduced Morningness - Eveningness Questionnaire (rMEQ), a widely used measure of chronotype i.e. time preference for daily activities, including bed-times. The rMEQ has five items yielding scores from 4 to 25, with lower scores indicating "eveningness" and higher scores indicating "morningness". Higher scores indicate higher levels of morningness. Scores can be divided into five categories: definitely evening type (score <8), moderately evening type (Score 8-11), neither type (score 12-17), moderately evening type (score 18-21), and definitely morning type (score >21)
Measured: 33 weeks after randomization
Chronotype at week 61 after randomization
Assessed with the Reduced Morningness - Eveningness Questionnaire (rMEQ), a widely used measure of chronotype i.e. time preference for daily activities, including bed-times. The rMEQ has five items yielding scores from 4 to 25, with lower scores indicating "eveningness" and higher scores indicating "morningness". Higher scores indicate higher levels of morningness. Scores can be divided into five categories: definitely evening type (score <8), moderately evening type (Score 8-11), neither type (score 12-17), moderately evening type (score 18-21), and definitely morning type (score >21)
Measured: 61 weeks after randomization
Frequency of nightmares at week 9 after randomization
Assessed with the Nightmare Frequency Questionnaire (NFQ), a 2-item measure for frequency of nights with nightmares (in days per week, month or year) and number of nightmares (per week, month or year) an individual has experienced the last three months
Measured: 9 weeks after randomization
Frequency of nightmares at week 33 after randomization
Assessed with the Nightmare Frequency Questionnaire (NFQ), a 2-item measure for frequency of nights with nightmares (in days per week, month or year) and number of nightmares (per week, month or year) an individual has experienced the last three months
Measured: 33 weeks after randomization
Frequency of nightmares at week 61 after randomization
Assessed with the Nightmare Frequency Questionnaire (NFQ), a 2-item measure for frequency of nights with nightmares (in days per week, month or year) and number of nightmares (per week, month or year) an individual has experienced the last three months
Measured: 61 weeks after randomization
Self-reported mental health status at week 9 after randomization
Assessed with the Outcome Questionnaire - 45.2 (OQ-45.2), a 45 item self-report scale for mental health status, specifically designed for patient progress throughout therapy. It has excellent internal consistency and is highly correlated with well-known outcomes such as the Symptom Checklist 90R, Beck Depression Inventory, The State Trait Inventory, The inventory of interpersonal problems, The Social Adjustment Scale, and the SF-36.34 The scale is scored on a scale of 0 (=never) to 5 (=almost always) giving a range of 0 to 180, with higher scores indicating higher levels of psychopathology. The OQ-45.2 has three validated subscales: symptom distress, interpersonal relations, and social role functioning (perceived level of difficulties in the workplace, school or home duties). Results will be reported for the sum score, and for the three subscales. The OQ-45.2 has an established clinical cut-off value and reliable change index
Measured: 9 weeks after randomization
Self-reported mental health status at week 33 after randomization
Assessed with the Outcome Questionnaire - 45.2 (OQ-45.2), a 45 item self-report scale for mental health status, specifically designed for patient progress throughout therapy. It has excellent internal consistency and is highly correlated with well-known outcomes such as the Symptom Checklist 90R, Beck Depression Inventory, The State Trait Inventory, The inventory of interpersonal problems, The Social Adjustment Scale, and the SF-36.34 The scale is scored on a scale of 0 (=never) to 5 (=almost always) giving a range of 0 to 180, with higher scores indicating higher levels of psychopathology. The OQ-45.2 has three validated subscales: symptom distress, interpersonal relations, and social role functioning (perceived level of difficulties in the workplace, school or home duties). Results will be reported for the sum score, and for the three subscales. The OQ-45.2 has an established clinical cut-off value and reliable change index
Measured: 33 weeks after randomization
Self-reported mental health status at week 61 after randomization
Assessed with the Outcome Questionnaire - 45.2 (OQ-45.2), a 45 item self-report scale for mental health status, specifically designed for patient progress throughout therapy. It has excellent internal consistency and is highly correlated with well-known outcomes such as the Symptom Checklist 90R, Beck Depression Inventory, The State Trait Inventory, The inventory of interpersonal problems, The Social Adjustment Scale, and the SF-36.34 The scale is scored on a scale of 0 (=never) to 5 (=almost always) giving a range of 0 to 180, with higher scores indicating higher levels of psychopathology. The OQ-45.2 has three validated subscales: symptom distress, interpersonal relations, and social role functioning (perceived level of difficulties in the workplace, school or home duties). Results will be reported for the sum score, and for the three subscales. The OQ-45.2 has an established clinical cut-off value and reliable change index
Measured: 61 weeks after randomization
Anxiety/depression at week 9 after randomization
Assessed with the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire for non-vegetative symptoms of anxiety and depression on a 0 to 3 likert scale. The sum score can be used as a measure of general psychological distress and is widely used in the community, general practice and psychiatric settings. It has a range of 0 to 42 points with higher scores indicating higher levels of psychological distress.
Measured: 9 weeks after randomization
Anxiety/depression at week 33 after randomization
Assessed with the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire for non-vegetative symptoms of anxiety and depression on a 0 to 3 likert scale. The sum score can be used as a measure of general psychological distress and is widely used in the community, general practice and psychiatric settings. It has a range of 0 to 42 points with higher scores indicating higher levels of psychological distress.
Measured: 33 weeks after randomization
Anxiety/depression at week 61 after randomization
Assessed with the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire for non-vegetative symptoms of anxiety and depression on a 0 to 3 likert scale. The sum score can be used as a measure of general psychological distress and is widely used in the community, general practice and psychiatric settings. It has a range of 0 to 42 points with higher scores indicating higher levels of psychological distress.
Measured: 61 weeks after randomization
Fatigue at week 9 after randomization
Assessed with the Chalder Fatigue Scale (CFS), a 11-item questionnaire for daytime physical and psychological fatigue on a 0 to 3 likert scale (0=less than usual, 3=much more than usual). The scale has a range of 0 to 33 with higher scores indicating higher levels of fatigue. Two additional items assess duration of fatigue (0=less than a week, 4=six months or more) and how much of the time the individual experience fatigue (0=25% of the time, 3=all the time)
Measured: 9 week after randomization
Fatigue at week 33 after randomization
Assessed with the Chalder Fatigue Scale (CFS), a 11-item questionnaire for daytime physical and psychological fatigue on a 0 to 3 likert scale (0=less than usual, 3=much more than usual). The scale has a range of 0 to 33 with higher scores indicating higher levels of fatigue. Two additional items assess duration of fatigue (0=less than a week, 4=six months or more) and how much of the time the individual experience fatigue (0=25% of the time, 3=all the time)
Measured: 33 weeks after randomization
Fatigue at week 61 after randomization
Assessed with the Chalder Fatigue Scale (CFS), a 11-item questionnaire for daytime physical and psychological fatigue on a 0 to 3 likert scale (0=less than usual, 3=much more than usual). The scale has a range of 0 to 33 with higher scores indicating higher levels of fatigue. Two additional items assess duration of fatigue (0=less than a week, 4=six months or more) and how much of the time the individual experience fatigue (0=25% of the time, 3=all the time)
Measured: 61 weeks after randomization
General health state at week 9 after randomization
Assessed with Euroqol-5D, a 5-item self-report questionnaire for general health state on a 0 to 5 likert scale. It measures levels of problems with walking, performing self-care, doing usual activities, pain/discomfort, and anxiety/depression. It is widely used across Europe in assessments of health resources utilization as it allows measurement of Quality Adjusted Life Years (QALYs) in individuals presenting with a wide range of physical and mental disorders
Measured: 9 weeks after randomization
General health state at week 33 after randomization
Assessed with Euroqol-5D, a 5-item self-report questionnaire for general health state on a 0 to 5 likert scale. It measures levels of problems with walking, performing self-care, doing usual activities, pain/discomfort, and anxiety/depression. It is widely used across Europe in assessments of health resources utilization as it allows measurement of Quality Adjusted Life Years (QALYs) in individuals presenting with a wide range of physical and mental disorders
Measured: 33 weeks after randomization
General health state at week 61 after randomization
Assessed with Euroqol-5D, a 5-item self-report questionnaire for general health state on a 0 to 5 likert scale. It measures levels of problems with walking, performing self-care, doing usual activities, pain/discomfort, and anxiety/depression. It is widely used across Europe in assessments of health resources utilization as it allows measurement of Quality Adjusted Life Years (QALYs) in individuals presenting with a wide range of physical and mental disorders
Measured: 61 weeks after randomization
Frequency of alcohol use at week 9 after randomization
Assessed with the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), a three-item self-report questionnaire assessing frequency of alcohol use (0=never, 4=four times each week or more), number of units typical for a drinking day (0=1-2 units, 4=10 or more units), and frequency of binge-drinking (0=never, 4=daily or almost daily). It is a short-version of the 10-item AUDIT developed by the World Health Organization
Measured: 9 weeks after randomization
Frequency of alcohol use at week 33 after randomization
Assessed with the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), a three-item self-report questionnaire assessing frequency of alcohol use (0=never, 4=four times each week or more), number of units typical for a drinking day (0=1-2 units, 4=10 or more units), and frequency of binge-drinking (0=never, 4=daily or almost daily). It is a short-version of the 10-item AUDIT developed by the World Health Organization
Measured: 33 weeks after randomization
Frequency of alcohol use at week 61 after randomization
Assessed with the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), a three-item self-report questionnaire assessing frequency of alcohol use (0=never, 4=four times each week or more), number of units typical for a drinking day (0=1-2 units, 4=10 or more units), and frequency of binge-drinking (0=never, 4=daily or almost daily). It is a short-version of the 10-item AUDIT developed by the World Health Organization
Measured: 61 weeks after randomization
Headache impact at week 9 after randomization
Assessed with the Headache Impact Test - 6 (HIT-6), a six-item self-report questionnaire assessing intensity and consequences of headaches the last month, rated from never to always. The scale has a range from 36 to 78 with higher values indicating higher severity of headaches.
Measured: 9 weeks after randomization
Headache impact at week 33 after randomization
Assessed with the Headache Impact Test - 6 (HIT-6), a six-item self-report questionnaire assessing intensity and consequences of headaches the last month, rated from never to always. The scale has a range from 36 to 78 with higher values indicating higher severity of headaches.
Measured: 33 weeks after randomization
Headache impact at week 61 after randomization
Assessed with the Headache Impact Test - 6 (HIT-6), a six-item self-report questionnaire assessing intensity and consequences of headaches the last month, rated from never to always. The scale has a range from 36 to 78 with higher values indicating higher severity of headaches.
Measured: 61 weeks after randomization
Work performance in daily living at week 9 after randomization
Assessed with the Work Productivity and Impairment Questionnaire General Health (WPAI:GH) for work performance and impairment in daily living. It is a six-item questionnaire that measures: sickness absenteeism; sickness presenteeism; overall work impairment and; activity impairment.
Measured: 9 weeks after randomization
Work performance in daily living at week 33 after randomization
Assessed with the Work Productivity and Impairment Questionnaire General Health (WPAI:GH) for work performance and impairment in daily living. It is a six-item questionnaire that measures: sickness absenteeism; sickness presenteeism; overall work impairment and; activity impairment.
Measured: 33 weeks after randomization
Work performance in daily living at week 61 after randomization
Assessed with the Work Productivity and Impairment Questionnaire General Health (WPAI:GH) for work performance and impairment in daily living. It is a six-item questionnaire that measures: sickness absenteeism; sickness presenteeism; overall work impairment and; activity impairment.
Measured: 61 weeks after randomization
Subjective cognitive disfunction at week 9 after randomization
Assessed with the Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA), a 16-item self-reported instrument of subjective cognitive dysfunctions including executive function, processing speed, working memory, verbal learning and memory, attention/concentration and mental tracking. Items are rated using a 4-point scale. The higher the score, the more subjective complaints. Although the assessment was initially introduced for use with individuals with bipolar disorders, the rating can be used ion other clinical populations
Measured: 9 weeks after randomization
Subjective cognitive disfunction at week 33 after randomization
Assessed with the Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA), a 16-item self-reported instrument of subjective cognitive dysfunctions including executive function, processing speed, working memory, verbal learning and memory, attention/concentration and mental tracking. Items are rated using a 4-point scale. The higher the score, the more subjective complaints. Although the assessment was initially introduced for use with individuals with bipolar disorders, the rating can be used ion other clinical populations
Measured: 33 weeks after randomization
Subjective cognitive disfunction at week 61 after randomization
Assessed with the Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA), a 16-item self-reported instrument of subjective cognitive dysfunctions including executive function, processing speed, working memory, verbal learning and memory, attention/concentration and mental tracking. Items are rated using a 4-point scale. The higher the score, the more subjective complaints. Although the assessment was initially introduced for use with individuals with bipolar disorders, the rating can be used ion other clinical populations
Measured: 61 weeks after randomization
Opinion on negative effects of the intervention at week 9 after randomization
Assessed with the Negative Effects Questionnaire (NEQ), a self-report measure that contains 20 items that are scored on a five-point Likert-scale (rated 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 intervention received or caused by other circumstances (yes/no), as well as one open-ended question
Measured: 9 weeks after randomization
Impact on future treatment at week 9 after randomization
This will be assessed post intervention with two items. The first will assess if this intervention has impacted motivation for face-to-face treatment for mental disorders, the second will assess if this intervention has impacted motivation for specifically working with sleep interventions at a later time (both scored on a 1 to 9 scale with 1=very unmotivated, 9=very motivated)
Measured: 9 weeks after randomization
Use of therapeutic techniques at week 9 after randomization
Assessed with the Use of Sleep Strategies (USS), a six item self-report questionnaire developed to measure how often individuals use six different therapeutic techniques (keep a stable rise time, refrain from sleeping during daytime, use the bed and bedroom only for sleeping, practiced sleep restriction, practiced stimulus control) and their perception of its utility. The techniques are integral to CBT-I but are also described in sleep psychoeducation or hygiene programmes
Measured: 9 weeks after randomization
Use of therapeutic techniques at week 33 after randomization
Assessed with the Use of Sleep Strategies (USS), a six item self-report questionnaire developed to measure how often individuals use six different therapeutic techniques (keep a stable rise time, refrain from sleeping during daytime, use the bed and bedroom only for sleeping, practiced sleep restriction, practiced stimulus control) and their perception of its utility. The techniques are integral to CBT-I but are also described in sleep psychoeducation or hygiene programmes
Measured: 33 weeks after randomization
Use of therapeutic techniques at week 61 after randomization
Assessed with the Use of Sleep Strategies (USS), a six item self-report questionnaire developed to measure how often individuals use six different therapeutic techniques (keep a stable rise time, refrain from sleeping during daytime, use the bed and bedroom only for sleeping, practiced sleep restriction, practiced stimulus control) and their perception of its utility. The techniques are integral to CBT-I but are also described in sleep psychoeducation or hygiene programmes
Measured: 61 weeks after randomization
Insomnia symptoms and severity at week 9 after randomization
Assessed with the Bergen Insomnia Scale (BIS). BIS comprises six items that assesses symptoms of insomnia based on the insomnia criteria found in the Diagnostic and Statistical Manual of Mental Disorders-IVTR (American Psychiatric Association).
Measured: 9 weeks after randomization
Insomnia symptoms and severity at week 33 after randomization
Assessed with the Bergen Insomnia Scale (BIS). BIS comprises six items that assesses symptoms of insomnia based on the insomnia criteria found in the Diagnostic and Statistical Manual of Mental Disorders-IVTR (American Psychiatric Association).
Measured: 33 weeks after randomization
Insomnia symptoms and severity at week 61 after randomization
Assessed with the Bergen Insomnia Scale (BIS). BIS comprises six items that assesses symptoms of insomnia based on the insomnia criteria found in the Diagnostic and Statistical Manual of Mental Disorders-IVTR (American Psychiatric Association).
Measured: 61 weeks after randomization
Use of health care services over the 12 month trial period
Number of appointments at mental health care clinics, type and timing of treatment and admissions, and date of the first appointment for each patient during the study period from the Norwegian Patient Registry. Longer term follow-up (>12 month) may be undertaken.
Measured: From 2 years before randomization to one year follow-up
Medication use at baseline over the 12 month trial period
Dose, timing, and type of prescribed hypnotic, sedative/anxiolytic, antidepressant and other psychotropic medications (According to the WHO Anatomical Therapeutic Chemical Classification System) and changes recorded during the RCT (data from the Norwegian Prescription Database). Longer term follow-up (>12 month) may be undertaken.
Measured: From 2 years before randomization to one year follow-up
Costs of treatment offered by the public services over the 12 month trial period
Data from the database named 'Kontroll og Utbetaling av Helserefusjon'. Longer term follow-up (>12 month) may be undertaken.
Measured: From 2 years before randomization to one year follow-up
Sick leave or in receipt of disability benefits over the 12 month trial period
Data from the administrative database called Forløpsdatabasen. Longer term follow-up (>12 month) may be undertaken.
Measured: From 2 years before randomization to one year follow-up
Cause of death
Data about the cause of death from the database called "Dødsårsaksregisteret". Longer term follow-up (>12 month) may be undertaken
Measured: From baseline to 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start24 Nov 2020
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 911 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Folkehelseinstituttet, University Hospital, Akershus, Helse Stavanger HF, University of Virginia, University of California, Berkeley, Helse Møre og Romsdal HF
- Responsible party
- Sponsor
- Investigators
- Pål Sandvik, md, Study director, St Olavs Hospital, Division of Mental Health CareHåvard Kallestad, phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621643
- Sponsor's protocol ID
- 125068
- Acronym
- Norse4
- Status last verified
- Feb 2025
- First submitted
- 17 Sep 2020
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data that underlie the results will be available after publication of the final version of the trial to researchers from accredited research institutions. Access to data will be limited to investigators who provide a methodologically sound proposal and will be for a specified time period (commencing about 3 months after publication and ending after five years). To ensure GDPR compliance, data processing must be covered by the 'Standard Contractual Clauses' from the European Commission, that data requesters have to sign. Proposals and requests for data access should be directed to the principal investigator.
Publications
Kallestad H, Saksvik S, Vedaa O, Langsrud K, Morken G, Lydersen S, Simpson MR, Dorheim SK, Holmoy B, Selvik SG, Hagen K, Stiles TC, Harvey A, Ritterband L, Sivertsen B, Scott J. Digital cognitive-behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial. BMJ Open. 2021 Jun 28;11(6):e050661. doi: 10.1136/bmjopen-2021-050661.
PubMed 34183350
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Controlled Trial of Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in Individuals Referred to Secondary Mental Health Services in Norway
- ClinicalTrials.gov ID
- NCT04621643
- Acronym / sponsor ID
- Norse4 / 125068
- Conditions
- Mental Disorder, Insomnia
- Keywords
- Cognitive Behavioral Therapy, Patient Education, Telemedicine, Waiting Lists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 911 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Folkehelseinstituttet, University Hospital, Akershus, Helse Stavanger HF, University of Virginia, University of California, Berkeley, Helse Møre og Romsdal HF
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 9 Nov 2020 (actual)
- 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.
Sleep is a fundamental human need with large impact on both psychological and somatic functioning. However, for patients with mental disorders, sleep is often disturbed. Across all diagnostic groups, sleep disturbance is one of the most common and disruptive symptoms. For decades it has been assumed that the sleep disturbance these patients experience was a secondary symptom of a primary mental disorder, but recently this has changed. Experimental and clinical data now suggest that there is a reciprocal relationship between sleep disturbance and mental disorders where they perpetuate and aggravate each other. This makes sleep disturbance a potential therapeutic target in the treatment of mental disorders. Evidence emerging the last decade indicate that providing Cognitive Behavior Therapy for Insomnia (CBT-I) to patients with mental disorders not only improves sleep, but also has clinically meaningful effects on their primary mental disorder. However, a major problem has been disseminating CBT-I and few therapists are trained in this intervention. Consequently, most patients receive sleep medication although evidence clearly indicate that CBT-I is more effective and should be the treatment of choice. In this study, the investigators will use a fully automated digital version of CBT-I that might be used to treat a large number of patients while they are still on the waiting list to receive ordinary outpatient treatment in secondary mental health care clinics in Norway. The main goal is to test the effectiveness of digital CBT-I for this patient group.
Detailed description
(27th May 2021) We have revised one of the study exclusion criteria. In the initial protocol we reported that we would exclude individuals with clinical evidence of sleep apnea, namely, we stated that: "Sleep apnea screening: An Epworth Sleepiness Scale (ESS) score >=13, indicative of high levels of objective daytime sleepiness associated with organic sleep disorders and/or positive endorsement of a screening question for sleep apnea (the item asks if they "usually or everyday snore and stop breathing and have difficulties staying awake during the day")." We have now modified the exclusion criterion, so that it is based on the screening question alone. Our updated exclusion criterion is now stated as follows: "Sleep apnea screening: A positive endorsement of a screening question for sleep apnea (the item asks if they "usually or everyday snore and stop breathing and have difficulties staying awake during the day")." i.e. the ESS score is no longer part of the assessment for eligibility for inclusion. The rationale for this change is that several publications and international experts have questioned the reliability and validity of the ESS cut-off score (>=13) when the scale is used in psychiatric outpatient populations (psychometrics in clinical samples are only modest when compared with ESS for screening community-based and/or non-clinical samples). As such ESS score is no longer used as an exclusion criterion, but we will continue to collect these data at baseline assessment and will report the ESS scores for the recruited sample.
At the time of making the amendment, 29 participants had been excluded on the basis of the ESS score.
(27th Feb, 2023): In the protocol that was approved by the Regional Committees for Medical and Health Research Ethics before inclusion started, under 'sample size', we wrote: "As the planned RCT involves limited contact between researchers and participants and has a 12-month follow-up, we have predicted that the study dropout rate is likely to reach about 50%. Therefore, we aim to recruit 800 participants, to enable us to retain 400 patients (200 in each treatment arm) at the end of the RCT."
We have now included 790 participants in this trial, and the attrition rate at the 12 month follow-up assessment is somewhat higher than predicted before we started the trial. Currently, 46% of the participants have completed the 12 month follow-up assessment. Based on this, we will not reach the target of retaining 400 participants at the end of the RCT with a sample size of 800 participants.
We have described the situation to the Regional Committees for Medical and Health Research Ethics. They have approved inclusion of new participants until June 30th 2023. This has been presented to the leaderships of the participating centers who also have approved inclusion until June 30th 2023. We will therefore recruit participants until this date. Based on our projections we will have retained at least 404 participants at the end of the RCT at this date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digital cognitive behavioral therapy (dCBT-I) | Experimental | Behavioral: digital cognitive behavioral therapy (dCBT-I) |
| Patient education about sleep (PE) | Active comparator | Behavioral: Digital patient education about insomnia (PE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing and able to provide written informed consent.
- Insomnia Severity Index (ISI) > 11 We have used this cut-off score previously to identify individuals who are likely to be experiencing clinical significant insomnia and who will potentially benefit from the dCBT-I intervention. Kallestad et al 2018 and a trial from Norway (Filosa et al in press) suggest that this cut-off is the most sensitive to detect a diagnosis of Insomnia Disorder.
Key exclusion criteria (8 listed)
- Sleep apnea screening: Positive endorsement of a screening question for sleep apnea (the item asks if they "usually or everyday snore and stop breathing and have difficulties staying awake during the day")
- Medical history indicative of (i) epilepsy plus self-report of >=1 seizure <12 months ago, or (ii) recent surgery for heart disease, or (iii) currently in an attack phase of multiple sclerosis.
- Individuals whose work schedule includes night shifts.
- Pregnancy
- Inadequate opportunity to sleep or circumstances prevent modification of sleep pattern (e.g. having a child aged<12 months residing home).
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 |
|---|---|---|
| digital cognitive behavioral therapy (dCBT-I)dCBT-I during 9 weeks. Multicomponent intervention that includes the following: psychoeducation about sleep, sleep hygiene, sleep restriction therapy, stimulus control and challenging beliefs and perception about sleep. The digital CBT-I that will be utilized in this study is named Sleep Healthy Using The internet (SHUTi). The intervention is fully automated with no contact with health care personnel, it is interactive and adapts to input from the users. It comprises of the same elements included in face-to-face CBT-I, but the user gains access to a new educational, behavioral or cognitive module each week only after completion of digital sleep diaries. dCBT-I can be accessed on computers or hand-held devices | Behavioural | digital cognitive behavioral therapy (dCBT-I) |
| Digital patient education about insomnia (PE)Control condition PE during 9 weeks. A digital patient education program that can be accessed on computers or hand-held devices. The information overlaps with that included in the dCBT-I intervention but it does not include any of the interactive features of the dCBT-I intervention and all the information is available from the moment the PE site is opened. | Behavioural | Patient education about sleep (PE) |
Primary outcome
Between-group difference in insomnia severity at week 9 after randomization
Time frame: 9 weeks after randomization
Assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.
48 secondary outcomes
Between-group difference in insomnia severity at week 33 after randomization
Time frame: 33 weeks after randomization
Between-group difference in insomnia severity at week 61 after randomization
Time frame: 61 weeks after randomization
Prospective daily sleep-wake pattern at week 9 after randomization
Time frame: 9 weeks after randomization
Prospective daily sleep-wake pattern at week 33 after randomization
Time frame: 33 weeks after randomization
Prospective daily sleep-wake pattern at week 61 after randomization
Time frame: 61 weeks after randomization
Chronotype at week 9 after randomization
Time frame: 9 weeks after randomization
Chronotype at week 33 after randomization
Time frame: 33 weeks after randomization
Chronotype at week 61 after randomization
Time frame: 61 weeks after randomization
Frequency of nightmares at week 9 after randomization
Time frame: 9 weeks after randomization
Frequency of nightmares at week 33 after randomization
Time frame: 33 weeks after randomization
Frequency of nightmares at week 61 after randomization
Time frame: 61 weeks after randomization
Self-reported mental health status at week 9 after randomization
Time frame: 9 weeks after randomization
Self-reported mental health status at week 33 after randomization
Time frame: 33 weeks after randomization
Self-reported mental health status at week 61 after randomization
Time frame: 61 weeks after randomization
Anxiety/depression at week 9 after randomization
Time frame: 9 weeks after randomization
Anxiety/depression at week 33 after randomization
Time frame: 33 weeks after randomization
Anxiety/depression at week 61 after randomization
Time frame: 61 weeks after randomization
Fatigue at week 9 after randomization
Time frame: 9 week after randomization
Fatigue at week 33 after randomization
Time frame: 33 weeks after randomization
Fatigue at week 61 after randomization
Time frame: 61 weeks after randomization
General health state at week 9 after randomization
Time frame: 9 weeks after randomization
General health state at week 33 after randomization
Time frame: 33 weeks after randomization
General health state at week 61 after randomization
Time frame: 61 weeks after randomization
Frequency of alcohol use at week 9 after randomization
Time frame: 9 weeks after randomization
Frequency of alcohol use at week 33 after randomization
Time frame: 33 weeks after randomization
Frequency of alcohol use at week 61 after randomization
Time frame: 61 weeks after randomization
Headache impact at week 9 after randomization
Time frame: 9 weeks after randomization
Headache impact at week 33 after randomization
Time frame: 33 weeks after randomization
Headache impact at week 61 after randomization
Time frame: 61 weeks after randomization
Work performance in daily living at week 9 after randomization
Time frame: 9 weeks after randomization
Work performance in daily living at week 33 after randomization
Time frame: 33 weeks after randomization
Work performance in daily living at week 61 after randomization
Time frame: 61 weeks after randomization
Subjective cognitive disfunction at week 9 after randomization
Time frame: 9 weeks after randomization
Subjective cognitive disfunction at week 33 after randomization
Time frame: 33 weeks after randomization
Subjective cognitive disfunction at week 61 after randomization
Time frame: 61 weeks after randomization
Opinion on negative effects of the intervention at week 9 after randomization
Time frame: 9 weeks after randomization
Impact on future treatment at week 9 after randomization
Time frame: 9 weeks after randomization
Use of therapeutic techniques at week 9 after randomization
Time frame: 9 weeks after randomization
Use of therapeutic techniques at week 33 after randomization
Time frame: 33 weeks after randomization
Use of therapeutic techniques at week 61 after randomization
Time frame: 61 weeks after randomization
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 26 Feb 2025.
- Derived from this study: PubMed 34183350Kallestad H, Saksvik S, Vedaa O, Langsrud K, Morken G, Lydersen S, Simpson MR, Dorheim SK, Holmoy B, Selvik SG, Hagen K, Stiles TC, Harvey A, Ritterband L, Sivertsen B, Scott J. Digital cognitive-behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial. BMJ Open. 2021 Jun 28;11(6):e050661. doi: 10.1136/bmjopen-2021-050661.
- Individual participant dataSharing planned: Yes. Anonymized data that underlie the results will be available after publication of the final version of the trial to researchers from accredited research institutions. Access to data will be limited to investigators who provide a methodologically sound proposal and will be for a specified time period (commencing about 3 months after publication and ending after five years). To ensure GDPR compliance, data processing must be covered by the 'Standard Contractual Clauses' from the European Commission, that data requesters have to sign. Proposals and requests for data access should be directed to the principal investigator.
Related trials for Mental Disorder
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
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.
Pål Sandvik, md study director
St Olavs Hospital, Division of Mental Health Care
Håvard Kallestad, phd principal investigator
Norwegian University of Science and Technology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital cognitive behavioral therapy (dCBT-I) and Digital patient education about insomnia (PE) in people with Mental Disorder and Insomnia, run by St. Olavs Hospital at 4 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 8 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 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Between-group difference in insomnia severity at week 9 after randomization (time frame: 9 weeks after randomization). 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 NCT04621643, which also lists 1 linked publication.
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 26 Feb 2025.