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Completed

NCT Number: NCT03425942

Internet Administered CBT for Insomnia Comorbid With Chronic Pain

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.

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Key information

Conditions

Insomnia Due to Medical Condition Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation medicine, IMH, Linköping University

Linköping, Östergötland County, SE 58185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Change from baseline insomnia severity (ISI) at 6 months

    Measures degree of insomnia. Range 0-28 where a higher value indicates worse sleep.

Secondary outcomes

  1. Sleep diary

    Time frame: Daily during treatment (five weeks).

    Basis for sleep latency, total sleep time, wake time after sleep onset and sleep efficiency.

  2. The Karolinska Sleepiness Scale (KSS)

    Time frame: Change from baseline sleepiness (KSS) at 5 weeks

    Measures sleepiness on a single item numeric rating scale. Range 1-9, where a higher value indicates more sleepiness.

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: Change from baseline health (PHQ-9) at 6 months

    Measures depressive symptoms. Range 0-27, where a higher value indicates more depressive symptoms.

  4. Generalised Anxiety Disorder 7-item scale (GAD-7)

    Time frame: Change from baseline anxiety (GAD-7) at 6 months

    Measures anxiety symptoms. Range 0-21 where a higher value indicates more anxiety.

  5. Pain intensity (NRS)

    Time frame: Change from baseline pain intensity (NRS) at 6 months

    Eleven stepped numeric rating scale (NRS) for average pain last seven days. Higher values indicate higher pain intensity.

  6. Pain Disability Index (PDI)

    Time frame: Change from baseline disability (PDI) at 6 months

    Quantifying pain related disability. Range 0-70 where a higher value indicates more disability.

Other outcomes

  1. Pain spreading (PS)

    Time frame: Change from baseline pain spreading (PS) at 6 months

    Number of anatomical regions with pain out of 36 anatomical areas.

  2. Negative Effects Questionnaire (NEQ)

    Time frame: at 5 weeks and at 6 months

    Monitoring and Reporting Adverse and Unwanted Events (32 items). Range 0-128 where a higher value indicates more adverse events.

  3. Patient Health Questionnaire (PHQ-4)

    Time frame: Change from baseline health (PHQ-4) at 5 weeks

    Measures depressive symptoms and anxiety. Range 0-12 where a higher value indicates more depressive or anxiety symptoms.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Acronym: SoV-studien

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2018
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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