Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet CBT for insomnia | Experimental | 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. |
|
| Internet ART for insomnia | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet Cognitive Behavioral Therapy for insomnia (ICBT-i) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep diary | Basis for sleep latency, total sleep time, wake time after sleep onset and sleep efficiency. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain spreading (PS) | Number of anatomical regions with pain out of 36 anatomical areas. | Change from baseline pain spreading (PS) at 6 months |
| Negative Effects Questionnaire (NEQ) | Monitoring and Reporting Adverse and Unwanted Events (32 items). Range 0-128 where a higher value indicates more adverse events. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Björn Gerdle, MD, PhD | Rehabilitation medicine, IMH, Linköping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation medicine, IMH, Linköping University | Linköping | Östergötland County | SE 58185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35486418 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants in both the experiment condition and the active control group were told that they received one of two active treatments in a comparative study.
|
| Internet Applied Relaxation Techniques (IART-i) | Behavioral | 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. |
|
| 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. | 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. | 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. | 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. | Change from baseline disability (PDI) at 6 months |
| at 5 weeks and at 6 months |
| Patient Health Questionnaire (PHQ-4) | Measures depressive symptoms and anxiety. Range 0-12 where a higher value indicates more depressive or anxiety symptoms. | Change from baseline health (PHQ-4) at 5 weeks |