Pain and Stress Management for Fibromyalgia

Emotional Exposure and Cognitive Behavioral Therapies 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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Stress and Emotions; Behavioral: Thoughts and Behaviors; Behavioral: Brain and Body

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan Medical Center
    • Detroit, Michigan, United States, 48202
      • Wayne State University
    • Southfield, Michigan, United States, 48075
      • St. John Providence Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Brief Pain Inventory	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
SF-12	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
PROMIS Fatigue short form	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Pittsburgh Sleep Quality Index	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Center for Epidemiological Studies - Depression Scale	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Generalized Anxiety Disorder - 7	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Positive and Negative Affect Schedule	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Satisfaction with Life Scale	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Multiple Ability Self-Report Questionnaire	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Patient Global Assessment of Change	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Health Care Utilization Scale	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Real-time Physical Activity (Actiwatch)	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Heart Rate Variability	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Levels of Emotional Awareness Scale	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Emotional Expressivity Scale	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Ambivalence over Emotional Expression	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Toronto Alexithymia Scale-20	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Impact of Events Scale - Revised	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
BBCA - short form	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Pain Catastrophizing	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Beliefs in Pain Control Questionnaire	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Communication Thoughts and Feelings Questionnaire	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Experimental (thumb nail pressure) threshold and tolerance ratings	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
2010 ACR modified clinical criteria for FM, including widespread pain index	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: University of Michigan; St. John Providence Hospital
• Investigators: Principal Investigator: Mark A Lumley, Ph.D., Wayne State University

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: January 28, 2011
• First Posted (Estimate): February 1, 2011

Study Record Updates

• Last Update Posted (Estimate): March 17, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Fibromyalgia; Behavioral interventions; Psychological interventions
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 1R01AR057808 (U.S. NIH Grant/Contract)