SoV-studien: Internet Administered CBT for Insomnia Comorbid With Chronic Pain
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Internet treatment with therapist support means that measurements are collected through the Internet. Participants are recruited from a specialized pain clinic for chronic pain. All patients with sleep complaints (Insomnia Severity Index > 14) at their first visit through 2016-01-01 to 2017-07-31 are asked for participation via mail. Volunteers sign informed consent and undergo a online screening. If matching the inclusion criteria, they are contacted for a telephone interview. Subjects are assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criterion for insomnia disorder, M.I.N.I. (screening for psychiatric comorbidity) and the other inclusion/exclusion criteria. The treatment, that is designed to be short, concise and user friendly as it is meant to be usable as an adjunct treatment to other main interventions for chronic pain. The treatment lasts for five weeks and focuses on the most potent CBT technics for insomnia; sleep restriction and stimulus control.
Randomization is conducted by university staff not otherwise involved in this study. Participants have equal chance to be allocated to ether CBT or applied relaxation techniques (active controls). The relaxation treatment lasts for the same amount of time (five weeks) and is designed to require similar weekly effort. Both groups fill in sleep diaries every week and weekly feedback is provided by master students supervised by clinical psychologists.
The overall hypothesis is that CBT leads to greater symptom reduction (according to the Insomnia Severity Index) compared to applied relaxation techniques.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Internet CBT for insomnia 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. |
Behavioral: Internet Cognitive Behavioral Therapy for insomnia (ICBT-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.
|
| Active Comparator: Internet ART for insomnia 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). |
Behavioral: Internet Applied Relaxation Techniques (IART-i)
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.
|
Outcome Measures
Primary Outcome Measures
- Insomnia Severity Index (ISI) [Change from baseline insomnia severity (ISI) at 6 months]
Measures degree of insomnia. Range 0-28 where a higher value indicates worse sleep.
Secondary Outcome Measures
- Sleep diary [Daily during treatment (five weeks).]
Basis for sleep latency, total sleep time, wake time after sleep onset and sleep efficiency.
- The Karolinska Sleepiness Scale (KSS) [Change from baseline sleepiness (KSS) at 5 weeks]
Measures sleepiness on a single item numeric rating scale. Range 1-9, where a higher value indicates more sleepiness.
- Patient Health Questionnaire (PHQ-9) [Change from baseline health (PHQ-9) at 6 months]
Measures depressive symptoms. Range 0-27, where a higher value indicates more depressive symptoms.
- Generalised Anxiety Disorder 7-item scale (GAD-7) [Change from baseline anxiety (GAD-7) at 6 months]
Measures anxiety symptoms. Range 0-21 where a higher value indicates more anxiety.
- Pain intensity (NRS) [Change from baseline pain intensity (NRS) at 6 months]
Eleven stepped numeric rating scale (NRS) for average pain last seven days. Higher values indicate higher pain intensity.
- Pain Disability Index (PDI) [Change from baseline disability (PDI) at 6 months]
Quantifying pain related disability. Range 0-70 where a higher value indicates more disability.
Other Outcome Measures
- Pain spreading (PS) [Change from baseline pain spreading (PS) at 6 months]
Number of anatomical regions with pain out of 36 anatomical areas.
- Negative Effects Questionnaire (NEQ) [at 5 weeks and at 6 months]
Monitoring and Reporting Adverse and Unwanted Events (32 items). Range 0-128 where a higher value indicates more adverse events.
- Patient Health Questionnaire (PHQ-4) [Change from baseline health (PHQ-4) at 5 weeks]
Measures depressive symptoms and anxiety. Range 0-12 where a higher value indicates more depressive or anxiety symptoms.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Insomnia severity index (ISI) score > 14
-
Chronic pain
Exclusion Criteria:
-
Shift worker or employed as a driver, operator of dangerous equipment and such
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Sleep apnea, restless legs syndrome, narcolepsy, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
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Bipolar disorder, psychotic disorders, ongoing substance abuse
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Having received CBT for insomnia during the latest year
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Pregnancy
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Severe somatic disorder (such as ongoing cancer, severe neurological condition, insufficiently treated cardiac condition)
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Impaired movement to such a degree that going to bed or getting out of bed requires assistance
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Not being able read or wright in Swedish
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Not having an internet-connected computer, cellular phone or tablet
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rehabilitation medicine, IMH, Linköping University | Linköping | Östergötland | Sweden | SE 58185 |
Sponsors and Collaborators
- Linkoeping University
Investigators
- Principal Investigator: Björn Gerdle, MD, PhD, Rehabilitation medicine, IMH, Linköping University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LIU-002