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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
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, Sweden
Insomnia Severity Index (ISI)
Measures degree of insomnia. Range 0-28 where a higher value indicates worse sleep.
Time frame: Change from baseline insomnia severity (ISI) at 6 months
Sleep diary
Basis for sleep latency, total sleep time, wake time after sleep onset and sleep efficiency.
Time frame: Daily during treatment (five weeks).
The Karolinska Sleepiness Scale (KSS)
Measures sleepiness on a single item numeric rating scale. Range 1-9, where a higher value indicates more sleepiness.
Time frame: Change from baseline sleepiness (KSS) at 5 weeks
Patient Health Questionnaire (PHQ-9)
Measures depressive symptoms. Range 0-27, where a higher value indicates more depressive symptoms.
Time frame: Change from baseline health (PHQ-9) at 6 months
Generalised Anxiety Disorder 7-item scale (GAD-7)
Measures anxiety symptoms. Range 0-21 where a higher value indicates more anxiety.
Time frame: Change from baseline anxiety (GAD-7) at 6 months
Pain intensity (NRS)
Eleven stepped numeric rating scale (NRS) for average pain last seven days. Higher values indicate higher pain intensity.
Time frame: Change from baseline pain intensity (NRS) at 6 months
Pain Disability Index (PDI)
Quantifying pain related disability. Range 0-70 where a higher value indicates more disability.
Time frame: Change from baseline disability (PDI) at 6 months
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