Pain and Stress Management for Fibromyalgia

• SF-12 [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
• PROMIS Fatigue short form [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
• Pittsburgh Sleep Quality Index [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
• Center for Epidemiological Studies - Depression Scale [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
• Generalized Anxiety Disorder - 7 [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
• Positive and Negative Affect Schedule [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
• Satisfaction with Life Scale [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
• Multiple Ability Self-Report Questionnaire [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
• Patient Global Assessment of Change [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
• Health Care Utilization Scale [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
• Real-time Physical Activity (Actiwatch) [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Heart Rate Variability [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Levels of Emotional Awareness Scale [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Emotional Expressivity Scale [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Ambivalence over Emotional Expression [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Toronto Alexithymia Scale-20 [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Impact of Events Scale - Revised [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• BBCA - short form [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Pain Catastrophizing [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Beliefs in Pain Control Questionnaire [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Communication Thoughts and Feelings Questionnaire [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Experimental (thumb nail pressure) threshold and tolerance ratings [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]

• SF-12 [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• PROMIS Fatigue short form [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Pittsburg Sleep Quality Index [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Center for Epidemiological Studies - Depression Scale [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Generalized Anxiety Disorder - 7 [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Positive and Negative Affect Schedule [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Satisfaction with Life Scale [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Multiple Ability Self-Report Questionnaire [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Patient Global Assessment of Change [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Health Care Utilization Scale [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Real-time Physical Activity (Actiwatch) [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Heart Rate Variability [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Levels of Emotional Awareness Scale [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Emotional Expressivity Scale [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Ambivalence over Emotional Expression [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Toronto Alexithymia Scale-20 [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Impact of Events Scale - Revised [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• BBCA - short form [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Pain Catastrophizing [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Beliefs in Pain Control Questionnaire [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
• Communication Thoughts and Feelings Questionnaire [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]

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.

• 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.
• Behavioral: Thoughts and Behaviors
  Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
• 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.

• 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.
  Intervention: Behavioral: Stress and Emotions
• 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.
  Intervention: Behavioral: Thoughts and Behaviors
• 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.
  Intervention: Behavioral: Brain and Body

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

• University of Michigan
• St. John Providence Hospital