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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638636
• Other study ID #: EPN 2015/1528-31/1
• Status: Completed
• Phase: N/A
• First received: December 17, 2015
• Last updated: December 13, 2016
• Start date: December 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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]	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No