Online Self-management in Fibromyalgia

NCT06322485 | Completed DMC

• 1 other identifier: P16.230
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study has been previously registered with the National Trial Registry (NTR6267) that has been cancelled. The registered trial has been automatically transferred to a new "Landelijk Trial Register", which does not contain all correct information on the current study and where no corrections can be made. Hence, the current study has been registered again with ClinicalTrials.gov. The goal of this clinical trial is to study the effectiveness of an internet-based self-management intervention in adult patients with fibromyalgia. A randomized controlled trial (RCT) will be performed, in which 70 participants will be randomized to either the self-management intervention or a waitlist control condition (patients in the waitlist condition will receive the intervention after the intervention ends in the intervention group, i.e., after 6 months). The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention. As secondary outcomes, a number of other psychological and physical outcome measures will be assessed (e.g., health-related quality of life, well-being, pain impact on daily life, pain cognitions). Also, cost-effectiveness of the intervention and the quality of the therapeutic relationship will be measured.

Conditions

Fibromyalgia

Keywords

internet-based cognitive-behavioral therapy; cognitive-behavioral therapy; web-based; self-management; fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change in pain coping

  A visual analogue scale (VAS) from 0 to 10 will be used to measure pain coping, with higher scores indicating better pain coping. The primary endpoint is the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention (immediately after the intervention).

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

Secondary Outcomes (9)

• Change in well-being

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

• Change in illness cognitions

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

• Change in pain coping strategies

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

• Change in Illness Perceptions

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

• Change in pain

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

Other Outcomes (5)

• Economic evaluation: Five-Level Version of the EQ-5D (EQ-5D-5L)

  Baseline, immediately after the intervention, at 3 months follow-up.

• Economic evaluation: iMTA Medical Consumption Questionnaire (iMCQ)

  Baseline, immediately after the intervention, at 3 months follow-up.

• Economic evaluation: iMTA Productivity Cost Questionnaire (iPCQ)

  Baseline, immediately after the intervention, at 3 months follow-up.

Study Arms (2)

Internet-based self-management intervention

EXPERIMENTAL

At the beginning of the treatment, a face-to-face introductory meeting is scheduled between the participant and a psychologist, where treatment goals will be set. Afterwards, a tailored self-management intervention, based on cognitive-behavioral methods, will be offered via an internet-based program. The psychologists offering the treatment have been trained in the tailored cognitive-behavioral protocol. One month and 2,5 months after finishing the online program, patients will be contacted by their treating psychologist for two booster sessions via telephone. Patients' goals will be evaluated and strategies to strengthen the achieved results will be discussed.

Behavioral: Internet-based self-management intervention

Waitlist

NO INTERVENTION

Patients in the control condition will be assigned to a waiting list and will receive the internet-based self-management intervention after the active treatment group (after 6 months).

Interventions

Internet-based self-management intervention BEHAVIORAL

An internet-based cognitive-behavioral therapy with six modules.

Internet-based self-management intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Difficulties with (written) communication (e.g., due to analphabetism) and with internet literacy.
• 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.

Sponsors & Collaborators

• Leiden University: lead
• Fibrocentrum: collaborator

Study Sites (1)

Fibrocentrum

Leiden, South Holland, 2321 GL, Netherlands

Location

Related Publications (1)

• Terpstra JA, van Beugen S, van der Vaart R, van Eersel RA, Dusseldorp E, Kloppenburg M, Evers AWM. An internet-based cognitive-behavioral self-management intervention for patients with hand osteoarthritis or fibromyalgia - Two randomized controlled trials. Internet Interv. 2026 Jan 19;43:100908. doi: 10.1016/j.invent.2026.100908. eCollection 2026 Mar.

  PMID: 41631249 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Andrea Evers, PhD

  Leiden University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of participants and practitioners is not possible due to the nature of the study. However, the statistician who creates the randomization schedule and performs statistical analyses is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: January 25, 2017
• Primary Completion: January 26, 2021
• Study Completion: January 26, 2021
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Individual participant data (IPD) will become available once an article on the study is published on DataverseNL; the statistical analysis plan will be published on ClinicalTrials.gov during registration (the plan was developed before data analysis takes place).
• Access Criteria: Open access.

Locations

NL (1)