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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Internet-based exposure therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm
    • Solna, Stockholm, Sweden, 17177
      • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Internet-based exposure therapy; 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.
No Intervention: Waitlist; Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment when the first group has finished (i.e. week 10).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	Change in sleep disturbances from baseline to Week 10, and at 6- and 12 months after treatment has ended.	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.	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.	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.	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.	Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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.	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.	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.	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.	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.	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.	Week 0, week 10, follow-up at 6- and 12-months after treatment has ended

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S)	Possible presence of suicidal thoughts or ideation during treatment	Week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8, week 9

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 19, 2015
• First Posted (Estimate): December 23, 2015

Study Record Updates

• Last Update Posted (Estimate): December 14, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Cognitive behavior therapy; Fibromyalgia; Exposure therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: EPN 2015/1528-31/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED