Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02638636
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Erik Andersson, 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Internet-based exposure therapy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.
Study Start Date : December 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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).



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: 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.

  2. Fatigue Severity Scale (FSS) [ Time Frame: 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.

  3. WHO Disability Assessment Schedule 2.0 (WHODAS 2) [ Time Frame: 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.

  4. Brunnsviken Brief Quality of Life Inventory (BBQ) [ Time Frame: 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.

  5. The Psychological Inflexibility in Pain Scale (PIPS) [ Time Frame: 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.

  6. Pain Reactivity Scale (PRS) [ Time Frame: 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.

  7. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 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.

  8. Generalised Anxiety Disorder 7-item scale (GAD-7) [ Time Frame: 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.

  9. Subscale "reactivity to inner experiences" from Five Facets of Mindfulness Questionnaire (FFMQ) [ Time Frame: 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.

  10. Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) [ Time Frame: 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.

  11. EQ5D [ Time Frame: 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.


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638636


Locations
Layout table for location information
Sweden
Karolinska Institutet
Solna, Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet

Layout table for additonal information
Responsible Party: Erik Andersson, Med Dr., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02638636     History of Changes
Other Study ID Numbers: EPN 2015/1528-31/1
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Erik Andersson, Karolinska Institutet:
Cognitive behavior therapy
Randomized controlled trial
Exposure therapy
Fibromyalgia

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases