Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to examine if an internet-based exposure therapy is effective in
      reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.
    

Detailed description: 
      Trial Objectives: Primary objective is to investigate whether an Internet-based exposure
      therapy can effectively reduce the degree of Fibromyalgia symptoms and impact. Secondary
      objectives are to 1) investigate the treatment's ability to reduce degree of a) quality of
      life b) function c) insomnia and fatigue d) pain-related fear and negative thoughts e)
      depression and anxiety, cost-effectiveness of this treatment; and 2) to study if any
      variables could moderate/mediate the treatment outcome, such as a) degree of covert
      avoidance, b) degree of reactivity to inner sensations

      Trial Design: Randomized controlled trial with waitlist control, who also will receive
      treatment after the first group has finished.

      Duration: Ten weeks

      Primary Endpoint: Change in Fibromyalgia symptoms and impact from baseline to Week 10. Long
      term follow-up is also investigated (potential changes from post-treatment to 6- and 12
      months after treatment completion)

      Efficacy Parameters: the Fibromyalgia Impact Questionnaire (FIQ)

      Description of Trial Subjects: Patients > 18 years old, Fibromyalgia diagnosis, residing in
      Sweden.

      Number of Subjects: 140

      Sample size estimation: Sample size is based on a estimated effect size (measured by Cohen's
      d) of 0.5, based on a power of 0.8 and with room for a 10 % dropout rate.

      Recruitment: Self-referral. Advertising will be made through national newspaper, social media
      and on patient organisations' websites.

      Safety parameters: Participants will have the opportunity to report any adverse events during
      treatment at posttreatment and follow-up measurements.

      Data collection: Data will be collected electronically via the treatment platform.

      Plan for missing data: Last-observation carried forward (LOCF).

      Main statistical analysis: Hierarchical linear mixed modelling.
    

Intervention name(s): Internet-based exposure therapy
Intervention type(s): Behavioral
Intervention description(s): The treatment is a 10 week long cognitive behavior therapy. It is based mainly on the principles of exposure; i.e. the participant is instructed to approach situations they have avoided in order to reduce or avoid pain or other aversive experiences until they feel less discomfort and extended behavior repertoire in presence of pain and aversive inner experiences Other interventions include psychoeducation, mindfulness and acceptance strategies and are employed in order to facilitate exposure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive behavior therapy; Randomized controlled trial; Exposure therapy; Fibromyalgia