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Pain and Stress Management for Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01287481
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : March 17, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Stress and Emotions Behavioral: Thoughts and Behaviors Behavioral: Brain and Body Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia
Study Start Date : May 2011
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Stress and Emotions
Seeks to reduce stress and physical symptoms by helping individual become aware of their emotions, express them, and resolve emotional difficulties. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
Behavioral: Stress and Emotions
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Active Comparator: Thoughts and Behaviors
Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms of fibromyalgia. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
Behavioral: Thoughts and Behaviors
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Active Comparator: Brain and Body
Seeks to help individuals improve health by educating about fibromyalgia so that one can better understand and more effectively communicate about their health. It will explain the latest scientific information about fibromyalgia, including its causes, the role of the nervous system and body, various medical and alternative treatments, and how to understand research findings.
Behavioral: Brain and Body
Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.


Outcome Measures

Primary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]

Secondary Outcome Measures :
  1. SF-12 [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]
  2. PROMIS Fatigue short form [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]
  3. Pittsburgh Sleep Quality Index [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]
  4. Center for Epidemiological Studies - Depression Scale [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]
  5. Generalized Anxiety Disorder - 7 [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]
  6. Positive and Negative Affect Schedule [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]
  7. Satisfaction with Life Scale [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]
  8. Multiple Ability Self-Report Questionnaire [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]
  9. Patient Global Assessment of Change [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]
  10. Health Care Utilization Scale [ Time Frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment ]
  11. Real-time Physical Activity (Actiwatch) [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  12. Heart Rate Variability [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  13. Levels of Emotional Awareness Scale [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  14. Emotional Expressivity Scale [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  15. Ambivalence over Emotional Expression [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  16. Toronto Alexithymia Scale-20 [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  17. Impact of Events Scale - Revised [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  18. BBCA - short form [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  19. Pain Catastrophizing [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  20. Beliefs in Pain Control Questionnaire [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  21. Communication Thoughts and Feelings Questionnaire [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  22. Experimental (thumb nail pressure) threshold and tolerance ratings [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]
  23. 2010 ACR modified clinical criteria for FM, including widespread pain index [ Time Frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:

    • 1990 ACR criteria including tender points
    • 2010 ACR modified clinical criteria that does not include tender points

Exclusion Criteria:

  • Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
  • Other serious medical conditions that can impair health status independent of FM
  • Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
  • Alcohol/drug dependence in past 2 years
  • Cognitive impairment or dementia
  • Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
  • Unable to fluently read or converse in English
  • Planning to move from the area in the next 14 months
  • Judgment of principle investigator as not appropriate for this trial or all intervention arms
Contacts and Locations

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): NCT01287481


Locations
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48106
Wayne State University
Detroit, Michigan, United States, 48202
St. John Providence Hospital
Southfield, Michigan, United States, 48075
Sponsors and Collaborators
Wayne State University
University of Michigan
St. John Providence Hospital
Investigators
Principal Investigator: Mark A Lumley, Ph.D. Wayne State University
More Information

Responsible Party: Mark A. Lumley, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01287481     History of Changes
Other Study ID Numbers: 1R01AR057808 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by Mark A. Lumley, Wayne State University:
Fibromyalgia
Behavioral interventions
Psychological interventions

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