Clinical trial NCT06322485: Online Self-management in Fibromyalgia
Official title: An Online Self-management Intervention for Patients With Hand Fibromyalgia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: internet-based cognitive-behavioral therapy
cognitive-behavioral therapy
web-based
self-management
fibromyalgia
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Fibrocentrum
First posted: 2024-03-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in pain coping
timeFrame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Secondary outcomes:
measure: Change in well-being
timeFrame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
measure: Change in illness cognitions
timeFrame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
measure: Change in pain coping strategies
timeFrame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
measure: Change in Illness Perceptions
timeFrame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
measure: Change in pain
timeFrame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
measure: Change in pain interference in daily functioning and pain severity, and as exploratory measures support, life control, and affective distress
timeFrame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
measure: Change in health-related quality of life
timeFrame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
measure: Change in fibromyalgia impact
timeFrame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
measure: Change in health-related quality of life
timeFrame: Baseline, immediately after the intervention, at 3 months follow-up.
Other outcomes:
measure: Economic evaluation: Five-Level Version of the EQ-5D (EQ-5D-5L)
timeFrame: Baseline, immediately after the intervention, at 3 months follow-up.
measure: Economic evaluation: iMTA Medical Consumption Questionnaire (iMCQ)
timeFrame: Baseline, immediately after the intervention, at 3 months follow-up.
measure: Economic evaluation: iMTA Productivity Cost Questionnaire (iPCQ)
timeFrame: Baseline, immediately after the intervention, at 3 months follow-up.
measure: Patient satisfaction
timeFrame: Immediately after the intervention.
measure: Expected/perceived patient-provider interaction
timeFrame: Baseline and immediately after the intervention.
Locations:
city: Leiden
country: Netherlands
facility: Fibrocentrum
state: Zuid-Holland
Study officials:
affiliation: Leiden University
name: Andrea Evers, PhD
role: PRINCIPAL_INVESTIGATOR
References: