Internet Administered CBT for Insomnia Comorbid With Chronic Pain

Chronic Pain Clinical Trial

— SoV-studien  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425942
• Other study ID #: LIU-002
• Status: Completed
• Phase: N/A
• Start date: February 9, 2018
• Est. completion date: May 14, 2019

Study information

• Verified date: January 2021
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 14, 2019
• Est. primary completion date: May 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

• Sleep apnea, restless legs syndrome, narcolepsy, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

• Bipolar disorder, psychotic disorders, ongoing substance abuse

• Having received CBT for insomnia during the latest year

• Pregnancy

• Severe somatic disorder (such as ongoing cancer, severe neurological condition, insufficiently treated cardiac condition)

• Impaired movement to such a degree that going to bed or getting out of bed requires assistance

• Not being able read or wright in Swedish

• Not having an internet-connected computer, cellular phone or tablet

Related Conditions & MeSH terms

• Chronic Pain
• Insomnia Due to Medical Condition
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Rehabilitation medicine, IMH, Linköping University	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain spreading (PS)	Number of anatomical regions with pain out of 36 anatomical areas.	Change from baseline pain spreading (PS) at 6 months
Other	Negative Effects Questionnaire (NEQ)	Monitoring and Reporting Adverse and Unwanted Events (32 items). Range 0-128 where a higher value indicates more adverse events.	at 5 weeks and at 6 months
Other	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
Primary	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
Secondary	Sleep diary	Basis for sleep latency, total sleep time, wake time after sleep onset and sleep efficiency.	Daily during treatment (five weeks).
Secondary	The Karolinska Sleepiness Scale (KSS)	Measures sleepiness on a single item numeric rating scale. Range 1-9, where a higher value indicates more sleepiness.	Change from baseline sleepiness (KSS) at 5 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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