Internet-based CBT for Insomnia in Chronic Pain

Chronic Pain Clinical Trial

— IBIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075683
• Other study ID #: 2016/510
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: May 2020
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Chronic Pain
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive behavioural therapy
Eight sessions of internet-based CBT for insomnia comorbid with chronic pain, with active therapist support.
• Applied relaxation
Eight sessions of internet-based applied relaxation for insomnia comorbid with chronic pain, with active therapist support.

Locations

Country	Name	City	State
Sweden	Uppsala university hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index	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.	8 weeks
Secondary	Sleep latency	Time to fall asleep (in minutes), derived from sleep diaries.	8 weeks
Secondary	Wake time after sleep onset	Wake time during the night (in minutes), derived from sleep diaries.	8 weeks