NCT03425942|Completed
Internet Administered CBT for Insomnia Comorbid With Chronic Pain
SoV-studien
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SoV-studien
Sponsor study identifier
interventional
54
1 country
1
Study Start
February 9, 2018
Actual (reported)Primary Completion
May 7, 2019
Actual (reported)Study Completion
May 14, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 14, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 24, 2018
Actual (reported)February 8, 2018
Actual (reported)February 9, 2018
Actual (reported)May 7, 2019
Actual (reported)May 14, 2019
Actual (reported)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
Sleep diary
Daily during treatment (five weeks).
The Karolinska Sleepiness Scale (KSS)
Change from baseline sleepiness (KSS) at 5 weeks
Patient Health Questionnaire (PHQ-9)
Change from baseline health (PHQ-9) at 6 months
Generalised Anxiety Disorder 7-item scale (GAD-7)
Change from baseline anxiety (GAD-7) at 6 months
Pain intensity (NRS)
Change from baseline pain intensity (NRS) at 6 months
Pain spreading (PS)
Change from baseline pain spreading (PS) at 6 months
Negative Effects Questionnaire (NEQ)
at 5 weeks and at 6 months
Patient Health Questionnaire (PHQ-4)
Change from baseline health (PHQ-4) at 5 weeks
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.
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).
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.
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.
Rehabilitation medicine, IMH, Linköping University
Linköping, Östergötland County, SE 58185, Sweden
Wiklund T, Molander P, Lindner P, Andersson G, Gerdle B, Dragioti E. Internet-Delivered Cognitive Behavioral Therapy for Insomnia Comorbid With Chronic Pain: Randomized Controlled Trial. J Med Internet Res. 2022 Apr 29;24(4):e29258. doi: 10.2196/29258.
Björn Gerdle, MD, PhD
Rehabilitation medicine, IMH, Linköping University
54 participants (actual enrollment reported by the registry).
First Submitted
January 24, 2018
First Posted
February 8, 2018
Study Start
February 9, 2018
Actual (reported)Smart Phone ACT Treatment for Adults With Longstanding Pain - a Pilot Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 7, 2019
Actual (reported)Study Completion
May 14, 2019
Actual (reported)Last Updated
January 11, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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