Internet-based CBT for Insomnia in Chronic Pain (IBIS)
Primary Purpose
Chronic Insomnia, Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behavioural therapy
Applied relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia focused on measuring Cognitive behavioural therapy, Non-pharmacological treatment, Internet mediated
Eligibility 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
Sites / Locations
- Uppsala university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive behavioural therapy
Applied relaxation
Arm Description
Internet-based cognitive behavioural therapy for insomnia
Internet-based applied relaxation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Sleep latency
Time to fall asleep (in minutes), derived from sleep diaries.
Wake time after sleep onset
Wake time during the night (in minutes), derived from sleep diaries.
Full Information
NCT ID
NCT03075683
First Posted
March 2, 2017
Last Updated
May 7, 2020
Sponsor
Uppsala University
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT03075683
Brief Title
Internet-based CBT for Insomnia in Chronic Pain
Acronym
IBIS
Official Title
Internet-based Cognitive Behavioural Therapy for Insomnia in Chronic Pain: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia, Chronic Pain
Keywords
Cognitive behavioural therapy, Non-pharmacological treatment, Internet mediated
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioural therapy
Arm Type
Experimental
Arm Description
Internet-based cognitive behavioural therapy for insomnia
Arm Title
Applied relaxation
Arm Type
Active Comparator
Arm Description
Internet-based applied relaxation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural therapy
Intervention Description
Eight sessions of internet-based CBT for insomnia comorbid with chronic pain, with active therapist support.
Intervention Type
Behavioral
Intervention Name(s)
Applied relaxation
Intervention Description
Eight sessions of internet-based applied relaxation for insomnia comorbid with chronic pain, with active therapist support.
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Sleep latency
Description
Time to fall asleep (in minutes), derived from sleep diaries.
Time Frame
8 weeks
Title
Wake time after sleep onset
Description
Wake time during the night (in minutes), derived from sleep diaries.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristoffer Bothelius, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala university hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Internet-based CBT for Insomnia in Chronic Pain
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