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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
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Chronic Pain Behavioral: Cognitive behavioural therapy Behavioral: Applied relaxation Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sleep latency [ Time Frame: 8 weeks ]
    Time to fall asleep (in minutes), derived from sleep diaries.

  2. Wake time after sleep onset [ Time Frame: 8 weeks ]
    Wake time during the night (in minutes), derived from sleep diaries.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Kristoffer Bothelius, PhD +47703981213 kristoffer.bothelius@psyk.uu.se
Contact: Rolf Karlsten, PhD +46186110000 rolf.karlsten@akademiska.se

Locations
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Sweden
Uppsala university hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Kristoffer Bothelius, PhD    703981213 ext +46    kristoffer.bothelius@psyk.uu.se   
Contact: Rolf Karlsten, PhD    186110000 ext +46    rolf.karlsten@akademiska.se   
Principal Investigator: Kristoffer Bothelius, PhD         
Sub-Investigator: Viktor Kaldo, PhD         
Sub-Investigator: Susanna Jernelöv, PhD         
Sub-Investigator: Markus Jansson-Fröjmark, PhD         
Sponsors and Collaborators
Uppsala University
Karolinska Institutet
Investigators
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Principal Investigator: Kristoffer Bothelius, PhD Uppsala University

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03075683     History of Changes
Other Study ID Numbers: 2016/510
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uppsala University:
Cognitive behavioural therapy
Non-pharmacological treatment
Internet mediated

Additional relevant MeSH terms:
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Chronic Pain
Sleep Initiation and Maintenance Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders