Internet Administered CBT for Insomnia Comorbid With Chronic Pain (SoV-studien)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Insomnia Due to Medical Condition
• Intervention / Treatment: Behavioral: Internet Cognitive Behavioral Therapy for insomnia (ICBT-i); Behavioral: Internet Applied Relaxation Techniques (IART-i)

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, SE 58185
      • Rehabilitation medicine, IMH, Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Björn Gerdle, MD, PhD, Rehabilitation medicine, IMH, Linköping University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2018
• Primary Completion (Actual): May 7, 2019
• Study Completion (Actual): May 14, 2019

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Cognitive Behavioral Therapy; Internet treatment; Applied Relaxation Techniques
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Chronic Pain; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: LIU-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No