Internet-based CBT for Insomnia in Chronic Pain

Study Overview
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Brief Summary
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The main goal is to study the effect of therapist-guided internet-delivered cognitive behavioural therapy for insomni comorbid with chronic pain in a clinical sample.

Detailed Description
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Both chronic pain and sleep disorders are prevalent and potentially very debilitating problem. The prevalence of insomnia in people with chronic pain seems to be about 50%, but figures up to 88% have been reported. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be an effective treatment for both primary insomnia and co-morbid insomnia. CBT-I is a psychotherapeutic multicomponent treatment that seeks to influence the behaviors and cognitions which perpetuates the problem. Usually, the treatment is 6-8 weeks long with one session a week, individually or in a small group setting. Internet Mediated CBT-I has been shown to be an effective alternative to more traditional CBT. How well internet mediated CBT-I work for individuals with insomnia and co-morbid chronic pain has however not previously been investigated. The aim of the project is to study the effects of internet mediated cognitive behavioral therapy for individuals with insomnia and co chronic benign pain. The aim is to compare the effect of Internet-mediated cognitive behavioral therapy with a group that offered internet-based relaxation training. CBT-I comprises eight modules with evidence-based treatment components for insomnia (e.g. sleep restriction, stimulus control and cognitive techniques). The relaxation training comprises eight modules of applied muscular relaxation. Hypothesis: Patients suffering from both insomnia and chronic benign pain gets significantly better treatment outcome with respect to insomnia symptoms if they receive internet-based cognitive behavioral therapy compared to those receiving internet mediated relaxation training. Primary outcome measure: the Insomnia Severity Index (ISI), a well-used, valid and reliable self-report scale, which has been shown possible to administer via internet.

Official Title
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Internet-based Cognitive Behavioural Therapy for Insomnia in Chronic Pain: a Randomised Controlled Trial

Conditions
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Chronic Insomnia, Chronic Pain

Intervention / Treatment
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* Behavioral: Cognitive behavioural therapy
* Behavioral: Applied relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic insomnia Chronic benign pain No or stable pharmacological treatment for insomnia and or pain Exclusion Criteria: Participation in pain management programme Pregnancy Shift work Untreated medical or psychiatric disease or disorder that could be negatively affected by insomnia treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: Randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioural therapy<br>Internet-based cognitive behavioural therapy for insomnia | Behavioral: Cognitive behavioural therapy<br>* Eight sessions of internet-based CBT for insomnia comorbid with chronic pain, with active therapist support.<br>|
| Active Comparator: Applied relaxation<br>Internet-based applied relaxation | Behavioral: Applied relaxation<br>* Eight sessions of internet-based applied relaxation for insomnia comorbid with chronic pain, with active therapist support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | A well-used, valid and reliable self-report questionnaire with seven items concerning subjective symptoms and consequences of insomnia ranging from 0 to 28 points. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep latency | Time to fall asleep (in minutes), derived from sleep diaries. | 8 weeks | 
| Wake time after sleep onset | Wake time during the night (in minutes), derived from sleep diaries. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavioural therapy, Non-pharmacological treatment, Internet mediated