Internet Administered CBT for Insomnia Comorbid With Chronic Pain

Study Overview
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Brief Summary
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Cognitive behavioural therapy (CBT), that is designed to be short, concise and user friendly is compared to applied relaxation techniques as treatment for insomnia comorbid with chronic pain. Both treatments are administered via internet and participants are randomized to ether treatment arm.

Detailed Description
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Internet treatment with therapist support means that measurements are collected through the Internet. Participants are recruited from a specialized pain clinic for chronic pain. All patients with sleep complaints (Insomnia Severity Index > 14) at their first visit through 2016-01-01 to 2017-07-31 are asked for participation via mail. Volunteers sign informed consent and undergo a online screening. If matching the inclusion criteria, they are contacted for a telephone interview. Subjects are assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criterion for insomnia disorder, M.I.N.I. (screening for psychiatric comorbidity) and the other inclusion/exclusion criteria. The treatment, that is designed to be short, concise and user friendly as it is meant to be usable as an adjunct treatment to other main interventions for chronic pain. The treatment lasts for five weeks and focuses on the most potent CBT technics for insomnia; sleep restriction and stimulus control. Randomization is conducted by university staff not otherwise involved in this study. Participants have equal chance to be allocated to ether CBT or applied relaxation techniques (active controls). The relaxation treatment lasts for the same amount of time (five weeks) and is designed to require similar weekly effort. Both groups fill in sleep diaries every week and weekly feedback is provided by master students supervised by clinical psychologists. The overall hypothesis is that CBT leads to greater symptom reduction (according to the Insomnia Severity Index) compared to applied relaxation techniques.

Official Title
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Internet Administered CBT for Insomnia Comorbid With Chronic Pain Compared to Applied Relaxation Techniques - A Randomized Controlled Trial

Conditions
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Insomnia Due to Medical Condition, Chronic Pain

Intervention / Treatment
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* Behavioral: Internet Cognitive Behavioral Therapy for insomnia (ICBT-i)
* Behavioral: Internet Applied Relaxation Techniques (IART-i)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insomnia severity index (ISI) score > 14 Chronic pain Exclusion Criteria: Shift worker or employed as a driver, operator of dangerous equipment and such Sleep apnea, restless legs syndrome, narcolepsy, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Bipolar disorder, psychotic disorders, ongoing substance abuse Having received CBT for insomnia during the latest year Pregnancy Severe somatic disorder (such as ongoing cancer, severe neurological condition, insufficiently treated cardiac condition) Impaired movement to such a degree that going to bed or getting out of bed requires assistance Not being able read or wright in Swedish Not having an internet-connected computer, cellular phone or tablet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet CBT for insomnia<br>The intervention consists of Internet-based Cognitive Behavioral Therapy for insomnia (ICBT-i) (the main components are sleep restriction and stimulus control) for five consecutive weeks. | Behavioral: Internet Cognitive Behavioral Therapy for insomnia (ICBT-i)<br>* This intervention lasts for five weeks. The intervention is internet-based and mainly consists of the most potent CBT technics i.e. sleep restriction and stimulus control. Weekly feedback is provided by master students supervised by clinical psychologists.<br>|
| Active Comparator: Internet ART for insomnia<br>The intervention consists of internet-based applied relaxation exercises/techniques (ART) (different and commonly used) for five consecutive weeks.The acronyme for this intervention is (IART-i). | Behavioral: Internet Applied Relaxation Techniques (IART-i)<br>* This intervention lasts for five weeks. The intervention is internet-based and consists of different common applied relaxation exercises and treatments. Weekly feedback is provided by master students supervised by clinical psychologists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | Measures degree of insomnia. Range 0-28 where a higher value indicates worse sleep. | Change from baseline insomnia severity (ISI) at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep diary | Basis for sleep latency, total sleep time, wake time after sleep onset and sleep efficiency. | Daily during treatment (five weeks). | 
| The Karolinska Sleepiness Scale (KSS) | Measures sleepiness on a single item numeric rating scale. Range 1-9, where a higher value indicates more sleepiness. | Change from baseline sleepiness (KSS) at 5 weeks | 
| Patient Health Questionnaire (PHQ-9) | Measures depressive symptoms. Range 0-27, where a higher value indicates more depressive symptoms. | Change from baseline health (PHQ-9) at 6 months | 
| Generalised Anxiety Disorder 7-item scale (GAD-7) | Measures anxiety symptoms. Range 0-21 where a higher value indicates more anxiety. | Change from baseline anxiety (GAD-7) at 6 months | 
| Pain intensity (NRS) | Eleven stepped numeric rating scale (NRS) for average pain last seven days. Higher values indicate higher pain intensity. | Change from baseline pain intensity (NRS) at 6 months | 
| Pain Disability Index (PDI) | Quantifying pain related disability. Range 0-70 where a higher value indicates more disability. | Change from baseline disability (PDI) at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy, Applied Relaxation Techniques, Internet treatment