An Online Self-management Intervention for Patients With Hand Fibromyalgia - a Randomized Controlled Trial

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.