Online Self-management in Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Behavioral: Internet-based self-management intervention
- Registration Number
- NCT06322485
- Lead Sponsor
- Leiden University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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.
Exclusion criteria:
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet-based self-management intervention 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.
- Primary Outcome Measures
Name Time Method Change in pain coping Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up. 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).
- Secondary Outcome Measures
Name Time Method Change in well-being Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up. A VAS from 0 to 10 will be used to measure well-being, with higher scores indicating better well-being.
Change in pain coping strategies Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up. Pain coping strategies will be assessed by the Pain Coping Inventory (PCI) that comprises six scales, namely, Pain Transformation, Distraction, and Reducing Demands (three active pain coping strategies), and Retreating, Worrying, and Resting (three passive pain coping strategies). Items are scored on a 4-point Likert scale ranging from "hardly ever" to "very often". Higher scale scores reflect greater use of the assessed pain coping strategy.
Change in fibromyalgia impact Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up. The Fibromyalgia Impact Questionnaire (FIQ) consists of 10 self-rated items covering the impact of fibromyalgia on different aspects of functioning and well-being. Total scores range from 0 to 100, with higher scores reflecting worse fibromyalgia impact.
Change in illness cognitions Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up. Illness cognitions will be assessed by the Illness Cognition Questionnaire (ICQ; using Helplessness and Acceptance scales). Items are scored on a 4-point Likert scale ranging from "not at all" to "completely". Higher scale scores reflect greater use of the assessed construct.
Change in pain Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up. A VAS ranging from 0 to 10 will be used to measure pain, with higher scores reflecting more severe pain.
Change in pain interference in daily functioning and pain severity, and as exploratory measures support, life control, and affective distress Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up. Part 1 of the Multidimensional Pain Inventory-Dutch Language Version (MPI-DLV) will be used with Interference and Pain Severity scales and as exploratory measures Support, Life Control, and Affective Distress. Items are rated on different 7-point Likert scales, with higher scores reflecting greater intensity in a subscale.
Change in Illness Perceptions Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up. Illness perceptions will be assessed by the Illness Perception Questionnaire (IPQ-R). The Identity scale consists of the sum of yes-rated items (patients rate whether they believe certain symptoms to be related to their illness). Furthermore, the remaining scales described below are rated on a 5-point Likert type scale ranging from "strongly disagree" to "strongly agree". High scores on the Timeline Acute/Chronic and Cyclical, Consequences, and Emotional Representations scales indicate beliefs about the chronicity and cyclical nature of the illness, the negative consequences of the illness, and patients' emotional experience of their illness. High scores on the Personal and Treatment Control and Illness Coherence scales reflect positive beliefs about perceived control and an understanding of the illness.
Change in health-related quality of life Baseline, immediately after the intervention, at 3 months follow-up. Health-related quality of life will be assessed by the Five-Level Version of the EQ-5D (EQ-5D-5L). In this questionnaire, 5 dimensions are measured in 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A 5-point Likert scale ranging from "no problems" to "extreme problems" is used for every dimension, with higher scores reflecting more problems in a dimension. A VAS ranging from 0 to 100 (0 = "The best health you can imagine" to 100 = "The worst health you can imagine") is applied as well, with higher scores indicating a better health state as perceived by the patient.
Trial Locations
- Locations (1)
Fibrocentrum
🇳🇱Leiden, Zuid-Holland, Netherlands