An online self-management intervention for patients with fibromyalgia -- a randomised controlled trial

Completed

• Conditions: fibromyalgie; fibromyalgia (FM); fibromyalgia syndrome (FMS)

• Registration Number: NL-OMON55570
• Lead Sponsor: niversiteit Leiden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-11-08
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

- Diagnosed with fibromyalgia, as previously confirmed by their treating GP or
a medical specialist
- Pain complaints with a minimal duration of 3 months
- Minimum age of 18 years
- Fluent in Dutch language
- Able to give informed consent
- Own a computer with internet access

Exclusion Criteria

- Difficulties in (written) communication (e.g., due to analphabetism)
- Severe physical and psychiatric comorbidities that interfere with the study
protocol, such as psychosis, addiction, suicidal ideation
- On-going psychological treatment elsewhere
- Participation in other clinical trials
- Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be pain coping, measured with a VAS score. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As secondary outcomes, a number of other psychological and physical outcome<br /><br>measures will be assessed (e.g., HR-QoL, well-being, pain impact on daily life,<br /><br>pain cognitions), as well as quality of the therapeutic relationship and<br /><br>cost-effectiveness of the intervention.</p><br>