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

NCT ID: NCT02638636

Last Updated: 2016-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-07-31

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.

Conditions

Fibromyalgia

Keywords

Cognitive behavior therapy; Randomized controlled trial; Exposure therapy; Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Internet-based exposure therapy

Intervention Type: BEHAVIORAL

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Erik Andersson

Med Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska Institutet

Solna, Stockholm County, Sweden

Countries

Sweden

References

Hedman-Lagerlof M, Andersson E, Ljotsson B, Engelbrektsson J, Lundback K, Bjorkander D, Hedman-Lagerlof E, Flink I, Axelsson E. Effect moderators in Internet-based exposure therapy for fibromyalgia: The role of pain intensity. Eur J Pain. 2023 Apr;27(4):507-517. doi: 10.1002/ejp.2074. Epub 2023 Jan 10.

Reference Type: DERIVED

PMID: 36585933 (View on PubMed)

Other Identifiers

EPN 2015/1528-31/1

Identifier Type: -

Identifier Source: org_study_id