Internet-based CBT for Insomnia in Chronic Pain

NCT ID: NCT03075683

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2019-07-01

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.

Conditions

Chronic Insomnia; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive behavioural therapy

Internet-based cognitive behavioural therapy for insomnia

Group Type: EXPERIMENTAL

Cognitive behavioural therapy

Intervention Type: BEHAVIORAL

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

Applied relaxation

Internet-based applied relaxation

Group Type: ACTIVE_COMPARATOR

Applied relaxation

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive behavioural therapy

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

Intervention Type: BEHAVIORAL

Applied relaxation

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristoffer Bothelius, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Uppsala university hospital

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

2016/510

Identifier Type: -

Identifier Source: org_study_id