Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Internet-based exposure therapy

• Registration Number: NCT02638636
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-19
• Study First Posted: 2015-12-23
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-13
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based exposure therapy	Internet-based exposure therapy	The experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into eight modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours.

Primary Outcome Measures

Name	Time	Method
Change in the Fibromyalgia Impact Questionnaire (FIQ)	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 Outcome Measures

Name	Time	Method
Fatigue Severity Scale (FSS)	Week 0, week 10, follow-up at 6- and 12-months after treatment has ended	Change in fatigue from baseline to Week 10, and 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	Change in level of function from baseline to Week 10, and 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	Change in covert avoidance from baseline to Week 10, and 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	Change in pain-related fear and negative thoughts from baseline to Week 10, and 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	Change in level of anxiety from baseline to Week 10, and 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	Change in sleep disturbances from baseline to Week 10, and 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	Change in quality of life from baseline to Week 10, and 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	Change in reactivity to inner experiences from baseline to Week 10, and 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	Change in level of depression from baseline to Week 10, and 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	Change in health-care costs and sick-leave from baseline to Week 10, and 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	Change in health-related quality of life from baseline to week 10, and at 6- and 12 months after treatment has ended.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Solna, Stockholm, Sweden