Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Karolinska Institutet
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Change in the Fibromyalgia Impact Questionnaire (FIQ)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Erik Andersson
Med Dr.
Karolinska Institutet
Eligibility Criteria
Inclusion Criteria
- •Fibromyalgia diagnosis
- •Swedish resident
- •Internet connection before, under and after treatment
- •Willing to refrain from other concurrent psychological treatment during the study
- •Agreement to keep psychotrophic medication constant during the study
Exclusion Criteria
- •Severe depression (≥30 points on Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S) or risk of suicide (≥4 points on the suicide item on MADRS-S)
- •Ongoing alcohol or substance abuse
- •Psychosis
- •Other severe illness that require immediate treatment and/or was considered the participants primary concern other than FM, or bodily condition that makes treatment unfeasible (such as late pregnancy; \>29 weeks gestation
- •Illiteracy or poor skills in Swedish language
- •Insufficient computer or language skills to manage a text-based treatment.
- •Other concurrent psychological treatment
- •Recent changes in psychotrophic medication (\<6 weeks prior to randomization)
Outcomes
Primary Outcomes
Change in the Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]
Change in Fibromyalgia symptoms and impact from baseline to Week 10, and at 6- and 12 months after treatment has ended.
Secondary Outcomes
- Fatigue Severity Scale (FSS)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- WHO Disability Assessment Schedule 2.0 (WHODAS 2)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- The Psychological Inflexibility in Pain Scale (PIPS)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Pain Reactivity Scale (PRS)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Generalised Anxiety Disorder 7-item scale (GAD-7)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Insomnia Severity Index (ISI)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Brunnsviken Brief Quality of Life Inventory (BBQ)(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)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- Patient Health Questionnaire-9 (PHQ-9)(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)(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)
- EQ5D(Week 0, week 10, follow-up at 6- and 12-months after treatment has ended)