Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in Individuals Referred to Public Mental Health Services in Norway (Norse4)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Insomnia; Mental Disorder
• Intervention / Treatment: Behavioral: digital cognitive behavioral therapy (dCBT-I); Behavioral: Digital patient education about insomnia (PE)

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 Type: Interventional
• Enrollment (Actual): 911
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Håvard Kallestad, phd; Phone Number: +47 93027262; Email: havard.kallestad@ntnu.no
• Study Contact Backup: Name: Simen Berg Saksvik; Email: simen.b.saksvik@ntnu.no

Study Locations

• Norway
  • Oslo, Norway
    • AHUS
  • Stavanger, Norway
    • Stavanger Universitetssykehus
  • Trondheim, Norway
    • St Olavs Hospital
  • Ålesund, Norway
    • Helse Møre og Romsdal HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. 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")
2. 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.
3. Individuals whose work schedule includes night shifts.
4. Pregnancy
5. Inadequate opportunity to sleep or circumstances prevent modification of sleep pattern (e.g. having a child aged<12 months residing home).
6. Currently receiving psychological treatment for insomnia.
7. Not a patient at one of the participating clinics.
8. Not having completed baseline assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: digital cognitive behavioral therapy (dCBT-I)	Behavioral: 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
Active Comparator: Patient education about sleep (PE)	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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)	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)	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)	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	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	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	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	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	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	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.	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.	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.	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)	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)	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)	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	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	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	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	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	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	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.	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.	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.	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.	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.	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.	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	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	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	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	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)	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	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	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	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).	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).	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).	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.	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.	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.	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.	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	From baseline to 12 month follow-up

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: University of California, Berkeley; Norwegian University of Science and Technology; Helse Stavanger HF; University of Virginia; University Hospital, Akershus; Helse Møre og Romsdal HF; Folkehelseinstituttet
• Investigators: Study Director: Pål Sandvik, md, St Olavs Hospital, Division of Mental Health Care; Principal Investigator: Håvard Kallestad, phd, Norwegian University of Science and Technology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Cognitive Behavioral Therapy; Patient Education; Waiting Lists
• Additional Relevant MeSH Terms: Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Mental Disorders
• Other Study ID Numbers: 125068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No