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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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.
Karolinska Institutet
Solna, Stockholm County, Sweden
Change in the Fibromyalgia Impact Questionnaire (FIQ)
Change in Fibromyalgia symptoms and impact from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]
Insomnia Severity Index (ISI)
Change in sleep disturbances from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Fatigue Severity Scale (FSS)
Change in fatigue from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
WHO Disability Assessment Schedule 2.0 (WHODAS 2)
Change in level of function from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Brunnsviken Brief Quality of Life Inventory (BBQ)
Change in quality of life from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
The Psychological Inflexibility in Pain Scale (PIPS)
Change in covert avoidance from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Pain Reactivity Scale (PRS)
Change in pain-related fear and negative thoughts from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Patient Health Questionnaire-9 (PHQ-9)
Change in level of depression from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Generalised Anxiety Disorder 7-item scale (GAD-7)
Change in level of anxiety from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Subscale "reactivity to inner experiences" from Five Facets of Mindfulness Questionnaire (FFMQ)
Change in reactivity to inner experiences from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Change in health-care costs and sick-leave from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
EQ5D
Change in health-related quality of life from baseline to week 10, and at 6- and 12 months after treatment has ended.
Time frame: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended