Internet-based CBT for Insomnia in Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Insomnia; Chronic Pain
• Interventions: Behavioral: Cognitive behavioural therapy; Behavioral: Applied relaxation

• Registration Number: NCT03075683
• Lead Sponsor: Uppsala University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Primary Completion: 2019-01-01
• Study Completion: 2019-07-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioural therapy	Cognitive behavioural therapy	Internet-based cognitive behavioural therapy for insomnia
Applied relaxation	Applied relaxation	Internet-based applied relaxation

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	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 Outcome Measures

Name	Time	Method
Wake time after sleep onset	8 weeks	Wake time during the night (in minutes), derived from sleep diaries.
Sleep latency	8 weeks	Time to fall asleep (in minutes), derived from sleep diaries.

Trial Locations

Locations (1)

Uppsala university hospital; 🇸🇪 Uppsala, Sweden