Online Self-management in Fibromyalgia

NCT ID: NCT06322485

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-25
• Study Completion Date: 2021-01-26

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.

Detailed Description

Rationale: Fibromyalgia has a high clinical burden, with patients experiencing considerable pain, physical disability, and an often decreased health-related quality of life (HR-QoL). Improving patients' skills in managing a chronic condition ("self-management") is increasingly recognized as vital in the treatment of somatic conditions and is becoming more common in clinical practice and research. In this study, the effectiveness of an internet-based self-management intervention focusing on coping skills related to chronic pain compared with a waitlist control condition is studied.

Objective: To study the effectiveness of the internet-based self-management intervention in patients with fibromyalgia.

Study design: An RCT will be performed, in which 70 patients will be randomized to either the internet-based self-management intervention or a waitlist control group. Baseline, post-intervention, 6-week, and three-month follow-up questionnaires will be used to measure primary and secondary outcomes.

Study population: Patients ≥18 years diagnosed with fibromyalgia (confirmed by their general practitioner or a medical specialist) who visit the 'Fibrocentrum', a fibromyalgia treatment centre in Leiden, The Netherlands, will be invited to participate in the study. Patients need to have a pain duration of a minimum of 3 months, be fluent in Dutch, be able to give informed consent, and own a computer with internet access. Difficulties with (written) communication and internet literacy, severe physical and psychiatric comorbidities that interfere with the study protocol (e.g., addiction, psychosis, and suicidal ideation), pregnancy, on-going psychological treatment elsewhere, and participation in other clinical trials are exclusion criteria.

Intervention: The cognitive-behavioral intervention begins with a face-to-face intake session in which personal goals for the intervention are set. Afterwards, the tailored self-management intervention, consisting of 6 modules, will be offered via an internet-based program. The first introductory module includes goal-setting and the last module includes relapse prevention; the four modules in between focus on learning how to cope with the consequences of a chronic condition in daily life. The topics of the modules are (1) activity, (2) mood, (3) thoughts, and (4) the social environment. At least once a week, a psychologist provides participants with feedback and motivational support through messages in a secured mail box in the internet-based program. After finishing the internet-based intervention, two booster sessions will take place via telephone (1 month and 2,5 months after the program). Patients will be called by their psychologist and their goals will be evaluated and strategies to strengthen the achieved results will be discussed.

Main study parameters/endpoints: The primary effect will be determined by comparing the VAS pain coping scores after the intervention between the waitlist control group and intervention group, corrected for baseline VAS pain coping scores. As secondary outcomes, several other psychological and physical outcomes will be measured (e.g., HR-QoL, pain cognitions, pain impact on daily life, well-being), as well as quality of the therapeutic relationship and cost-effectiveness of the intervention.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the waitlist control condition, patients will receive the intervention after the intervention ends in the intervention group (after 6 months). In the intervention group patients will be offered an internet-based self-management intervention, which could improve their pain coping and other psychological and physical outcomes. No risk is involved with participation in this study. The only burden for participants is time investment.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based self-management intervention

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.

Group Type: EXPERIMENTAL

Internet-based self-management intervention

Intervention Type: BEHAVIORAL

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

Waitlist

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internet-based self-management intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with fibromyalgia, as previously confirmed by their treating general practitioner or a medical specialist.

2. Pain complaints with a minimal duration of 3 months.

3. Minimum age of 18 years.

4. Fluent in Dutch.

5. Able to give informed consent.

6. Own a computer with internet access.

Exclusion Criteria

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

2. Severe physical and psychiatric comorbidities that interfere with the study protocol, such as psychosis, addiction, suicidal ideation.

3. On-going psychological treatment elsewhere.

4. Participation in other clinical trials.

5. Pregnancy.

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

Sponsors

Fibrocentrum

UNKNOWN

Sponsor Role: collaborator

Leiden University

OTHER

Sponsor Role: lead

Responsible Party

Andrea W.M Evers, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Evers, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University

Locations

Fibrocentrum

Leiden, South Holland, Netherlands

Countries

Netherlands

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P16.230

Identifier Type: -

Identifier Source: org_study_id