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Completed

NCT Number: NCT03075683

Internet-based CBT for Insomnia in Chronic Pain

The main goal is to study the effect of therapist-guided internet-delivered cognitive behavioural therapy for insomni comorbid with chronic pain in a clinical sample.

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Key information

Conditions

Chronic Insomnia Chronic Pain Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala university hospital

Uppsala, 751 85, Sweden

About this study

Both chronic pain and sleep disorders are prevalent and potentially very debilitating problem. The prevalence of insomnia in people with chronic pain seems to be about 50%, but figures up to 88% have been reported. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be an effective treatment for both primary insomnia and co-morbid insomnia. CBT-I is a psychotherapeutic multicomponent treatment that seeks to influence the behaviors and cognitions which perpetuates the problem. Usually, the treatment is 6-8 weeks long with one session a week, individually or in a small group setting.

Internet Mediated CBT-I has been shown to be an effective alternative to more traditional CBT. How well internet mediated CBT-I work for individuals with insomnia and co-morbid chronic pain has however not previously been investigated. The aim of the project is to study the effects of internet mediated cognitive behavioral therapy for individuals with insomnia and co chronic benign pain. The aim is to compare the effect of Internet-mediated cognitive behavioral therapy with a group that offered internet-based relaxation training. CBT-I comprises eight modules with evidence-based treatment components for insomnia (e.g. sleep restriction, stimulus control and cognitive techniques). The relaxation training comprises eight modules of applied muscular relaxation.

Hypothesis: Patients suffering from both insomnia and chronic benign pain gets significantly better treatment outcome with respect to insomnia symptoms if they receive internet-based cognitive behavioral therapy compared to those receiving internet mediated relaxation training.

Primary outcome measure: the Insomnia Severity Index (ISI), a well-used, valid and reliable self-report scale, which has been shown possible to administer via internet.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic insomnia Chronic benign pain No or stable pharmacological treatment for insomnia and or pain

Exclusion criteria

  • Participation in pain management programme Pregnancy Shift work Untreated medical or psychiatric disease or disorder that could be negatively affected by insomnia treatment

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

Eight sessions of internet-based CBT for insomnia comorbid with chronic pain, with active therapist support.

Applied Relaxation

Behavioral

Eight sessions of internet-based applied relaxation for insomnia comorbid with chronic pain, with active therapist support.

Primary outcomes

  1. Insomnia Severity Index

    Time frame: 8 weeks

    A well-used, valid and reliable self-report questionnaire with seven items concerning subjective symptoms and consequences of insomnia ranging from 0 to 28 points.

Secondary outcomes

  1. Sleep latency

    Time frame: 8 weeks

    Time to fall asleep (in minutes), derived from sleep diaries.

  2. Wake time after sleep onset

    Time frame: 8 weeks

    Wake time during the night (in minutes), derived from sleep diaries.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Internet-based Cognitive Behavioural Therapy for Insomnia in Chronic Pain: a Randomised Controlled Trial

Acronym: IBIS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2017
Registry last updated
May 8, 2020

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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