Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I

Study Overview
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Brief Summary
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Insomnia is a major public health concern. While cognitive behavior therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socio-economic benefits and its impact on health resource utilization. The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave, as well as medication and health resource utilization. Also, we will examine putative mediators and selected potential psycho-bio-social moderators of the effects of the intervention.

Detailed Description
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This is a two-arm RCT that assesses the benefits of online CBT-I compared with an alternative, active control intervention (online patient education about sleep (PE)). We will randomize 1500 individuals and collect follow-up data for up to two years. First, we will examine any differential change in the severity of insomnia, immediately after completing the interventions. Secondly, we will examine if there are differential changes in symptoms of physical and mental health (e.g. psychological distress, fatigue, and health related quality of life) immediately post-intervention, and whether any improvements in insomnia or other symptoms are reported at further follow-ups (6- and 24 months post treatment termination). Third, we will use national registry data collected routinely in Norway to compare rates of time off work due to sick leave days for up to two years before and after participating in the RCT, as well as monitoring medication and health resource utilization according to condition in the same time interval. Fourth, we will try to extend the knowledge base about online interventions by undertaking exploratory analyses to assess whether change in specific clinical variables (e.g. sleep variability, psychological measures of beliefs about sleep) mediate the effects of the CBT-I intervention. Lastly, (subject to additional funding to collect saliva samples), we will examine a subset of psycho-bio-social factors to try to identify potential treatment moderators that might inform the stratification of individuals with insomnia into 'treatment-relevant' subgroups in the future (e.g. this may include also an exploration of 'therapygenetics').

Official Title
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Overcoming Insomnia: A Large-scale Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia Compared With Online Patient Education About Sleep.

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: CBT for insomnia (CBT-I)
* Behavioral: Psycho-Education about Sleep (PE)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Individuals aged >=18 years who score >= 12 on the Insomnia Severity Index (a score indicative of insomnia symptoms that significantly impact on individuals) Willing and able to give online informed consent. Exclusion criteria: Individuals scoring >10 on the Epworth Sleepiness Scale (ESS) (which is suggestive of excessive daytime sleepiness) and/or answering that they usually or every day snore and stop breathing and have difficulties staying awake during the day (i.e., they positively endorse pre-selected indicators of sleep apnoea); Self-report of the presence of any medical conditions where a fully automated CBT-I may be contra-indicated (e.g. epilepsy, bipolar disorder, schizophrenia or psychotic disorders, and recent heart surgery) Participating in shift work.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a parallel-group superiority RCT comparing internet-delivered CBT-I (a Norwegian language version of SHUTi) with online patient education about sleep (PE).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT for insomnia (CBT-I)<br>Internet-based cognitive-behavioral therapy for insomnia (CBT-I) comprises a fully automated, interactive, and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention | Behavioral: CBT for insomnia (CBT-I)<br>* CBT-I is an online, fully automated, interactive, and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention.<br>* Other names: SHUTi;|
| Active Comparator: Psychoeducation about Sleep (PE)<br>The PE intervention gives participants access to a website with information about insomnia symptoms; the impact, prevalence, and causes of insomnia; when to seek input from a doctor; and basic lifestyle, environmental, and behavioral strategies that may help to improve sleep. | Behavioral: Psycho-Education about Sleep (PE)<br>* PE provides online information about insomnia symptoms; the impact, prevalence, and causes of insomnia; when to seek input from a doctor; and basic lifestyle, environmental, and behavioral strategies that may help to improve sleep.<br>* Other names: passive education/ sleep hygeine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index, ISI | The ISI will be used to assess self-reported levels of insomnia severity. Range is 0-28. Higher values represent higher levels of insomnia symptom severity. | Pre to 9 weeks post randomization (post treatment assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index, ISI | The ISI will be used to assess self-reported levels of insomnia severity. Range is 0-28. Higher values represent higher levels of insomnia symptom severity. | Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Sleep diaries | Sleep diaries will be used to get daily information about: Sleep duration, sleep onset latency, wake after sleep onset, number of awakenings, bed time, rise time, time for final awakening before rise time, medication used, alchohol/drug use, variability. Individuals keep a record for at least 10 of 14 consecutive days. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Hospital Anxiety and Depression Scale, HADS | The HADS will be used to assess levels of anxiety and depression. The HADS comprises 14 items (higher values indicate higher symptom severity) pertaining to non-vegetative symptoms of anxiety and depression, which makes it a suitable measure of general psychological distress in populations likely to have physical comorbidities (e.g. general practice and liaison psychiatry settings). | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Short Form-12, SF-12 | The SF-12 is an abbreviated version of the MOS 36-item short-form health survey (SF-36), and measures the individuals' perceived physical and mental health status. The SF-12 is scored using the recommended MOS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as T-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Dysfunctional Beliefs About Sleep scale, DBAS | The DBAS is a self-report questionnaire designed to identify maladaptive sleep- and insomnia-related cognitions. Patients are given a list of 16 statements reflecting different beliefs and attitudes about sleep, and they are asked to indicate on a 10-point scale how much they agree with the statements. Higher scores indicate higher levels of endorsement of beliefs. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Chalder Fatigue Questionnaire, CFQ | The CFQ comprises 11 items addressing physical and psychological fatigue, and two items addressing the duration and the intensity of fatigue complaints. Higher values indicate higher levels of fatigue. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| The Bergen Insomnia Scale, BIS | The BIS comprises six items that assesses symptoms of insomnia based on the insomnia criteria found in the Diagnostic and Statistical Manual of Mental Disorders-IV-TR (American Psychiatric Association). Higher values indicate higher levels of insomnia severity. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Brief Horne-Östberg Morningness-Eveningness Questionnaire, MEQ | The MEQ is the most widely used measure of chronotype (so-called 'morningness' or 'eveningness'), and gives an indication of the respondents preferred (as opposed to actual) rise-time and bed-time. Higher scores indicate higher levels of morningness. | Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Physical health | A 20-item checklist of common medical conditions and any impact on work or personal life. Also used in the Helseundersøkelsen Nordtrøndelag study (the HUNT study). | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Mental health | Presence of psychiatric conditions will be assessed with an 8-item checklist of common psychiatric conditions based on a template used for physical health in the Helseundersøkelsen Nordtrøndelag study (the HUNT study). | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Pain site | A self-report checklist (yes/no) of nine sites on the body where one can experience pain. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Alcohol use disorders identification test - consumption , AUDIT-C | The AUDIT-C scale comprises of three items and will be used to assess the frequency and quantity of alcohol consumption where higher scores indicate higher levels of use. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Body Mass Index | Height will be recorded at baseline and weight will be recorded at baseline, post-intervention, 6 and 24 months to allow estimation of body mass index (kg/m^2) at these time points. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Physical activity | Level of self-reported physical activity is measured using six items (from the HUNT study) that assess frequency, intensity and duration of the activity. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| National Insurance Administration (NIA) | Objective data on days with sick leave will be determined with data from the NIA, a national Norwegian registry which records all periods of sick leave >13 days, as well as information on all disability pension awards. | Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization | 
| Norwegian Patient Registry (NPR) | Objective data on the use and type of specialist health care services will be determined using the NPR, a national Norwegian registry which contains information about all patients who are waiting for, or have received treatment, as outpatients in the specialist health service. The data retrieved from the NPR include diagnoses (according to ICD-10 criteria), name of health care provider, service use (e.g. outpatient appointments) and hospital admission and discharge dates. | Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization | 
| Norwegian Prescription Database (NorPD) | Medication use will be determined from NorPD, a national health register comprising information on all prescriptions dispensed at Norwegian pharmacies (since January 2004). The NorPD provides detailed information that will allow us to identify the medication, its class, and information on dispensed prescriptions (which can be used as a proxy for medication consumption). | Pre intervention, 12 months and 9 weeks after randomization, and 24 months and 9 weeks after randomization | 
| Help seeking behavior | A self-report 10-item questionnaire that records what help or treatments that have been sought. | 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Medication use | Free text where participants report reason for medication use, dosage, timing, and adherence. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Use of health care services | Subjective reports of health care service use will be assessed with 5 items recording use of primary and secondary health services. | Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Absence from work and loss of productivity | A self-report 7 item questionnaire that assess absence from work and loss of productivity due to health problems. | Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Impact of health problems on productivity | 2 items recording self-perceptions of any negative effects of health status on work or leisure activities. | Pre, 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Internet intervention evaluation | The acceptability of online interventions after completion of the programs will be assessed with the Internet intervention evaluation which comprises two questionnaires used in SHUTi research: the Internet Intervention Utility Questionnaire (UQ) and the Internet Intervention Impact Questionnaire (IQ). | 9 weeks after randomization (post assessment), and 24 months follow-up (24 months and 9 weeks after randomization) | 
| Electronic Media Use | Self-report ratings of how much daily time participants spend, and how much time they spend while in bed, on different five different types of electronic media. | Pre, 9 weeks after randomization (post assessment), 6 months follow-up (6 months and 9 weeks after randomization), 24 months follow-up (24 months and 9 weeks after randomization) | 
| Negative Effects Questionnaire, NEQ | To assess views regarding the interventions, we will ask participants to complete the NEQ. The NEQ is a self-report measure that contains 32 items that are scored on a five point Likert-scale (0-4) where higher scores indicate higher levels of negative effects. After each item, the individual is asked whether they consider the effect to be caused by the treatment received or caused by other circumstances (yes/no), as well as one open-ended question. | 24 months follow-up (24 months and 9 weeks after randomization) | 
| Use of sleep strategies questionnaire | A self-report questionnaire has been developed in order to assess patients continued use of sleep strategies after the intervention. The questionnaire comprises 6 items assessing how many times each week the last month patients have used 6 different therapeutic techniques used in Cognitive Behavior Therapy for Insomnia (incl. kept a stable rise time, refrained from sleeping during daytime, used the bed and the bedroom only for sleeping, practiced sleep restriction, got out of the bed when unable to fall asleep within 15-20 minutes, and kept a sleep diary), how useful each technique was on a 0 to 10 scale where higher score indicates higher level of usefulness, and whether the patients have used the technique regularly since terminating treatment (yes/no). | 24 months follow-up (24 months and 9 weeks after randomization) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapy, CBT-I, internet-based, online, short-term benefits, medium-term outcomes, health resource use, sick leave