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Completed

NCT Number: NCT01287481

Pain and Stress Management for Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan Medical Center, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress and Emotions

Behavioral

Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.

Thoughts and Behaviors

Behavioral

Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.

Brain and Body

Behavioral

Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.

Primary outcomes

  1. Brief Pain Inventory

    Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • St. John Providence Hospital
  • University of Michigan

Registry information

Official study title

Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2011
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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