NCT03425942

Internet Administered CBT for Insomnia Comorbid With Chronic Pain

Internet Administered CBT for Insomnia Comorbid With Chronic Pain Compared to Applied Relaxation Techniques - A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Linkoeping University · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Insomnia Due to Medical Condition
• Chronic Pain

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-02-09
• Primary completion: 2019-05-07
• Completion: 2019-05-14
• First posted: 2018-02-08
• Last updated: 2021-01-11

Locations

1 site across 1 country: Sweden