Internet-based CBT for Insomnia in Chronic Pain (IBIS)
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|ClinicalTrials.gov Identifier: NCT03075683|
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Insomnia Chronic Pain||Behavioral: Cognitive behavioural therapy Behavioral: Applied relaxation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised controlled trial|
|Official Title:||Internet-based Cognitive Behavioural Therapy for Insomnia in Chronic Pain: a Randomised Controlled Trial|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Experimental: Cognitive behavioural therapy
Internet-based cognitive behavioural therapy for insomnia
Behavioral: Cognitive behavioural therapy
Eight sessions of internet-based CBT for insomnia comorbid with chronic pain, with active therapist support.
Active Comparator: Applied relaxation
Internet-based applied relaxation
Behavioral: Applied relaxation
Eight sessions of internet-based applied relaxation for insomnia comorbid with chronic pain, with active therapist support.
- Insomnia Severity Index [ Time Frame: 8 weeks ]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.
- Sleep latency [ Time Frame: 8 weeks ]Time to fall asleep (in minutes), derived from sleep diaries.
- Wake time after sleep onset [ Time Frame: 8 weeks ]Wake time during the night (in minutes), derived from sleep diaries.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075683
|Contact: Kristoffer Bothelius, PhDemail@example.com|
|Contact: Rolf Karlsten, PhDfirstname.lastname@example.org|
|Uppsala university hospital||Recruiting|
|Uppsala, Sweden, 751 85|
|Contact: Kristoffer Bothelius, PhD 703981213 ext +46 email@example.com|
|Contact: Rolf Karlsten, PhD 186110000 ext +46 firstname.lastname@example.org|
|Principal Investigator: Kristoffer Bothelius, PhD|
|Sub-Investigator: Viktor Kaldo, PhD|
|Sub-Investigator: Susanna Jernelöv, PhD|
|Sub-Investigator: Markus Jansson-Fröjmark, PhD|
|Principal Investigator:||Kristoffer Bothelius, PhD||Uppsala University|