Pain and Stress Management for Fibromyalgia

Wayne State University

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia

Treatments: Behavioral: Brain and Body; Behavioral: Thoughts and Behaviors; Behavioral: Stress and Emotions

Study type: Interventional

Funder types: Other

Identifiers

NCT01287481

1R01AR057808

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

230 participants in 3 patient groups

Stress and Emotions

Experimental group

Description:

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.

Treatment:

Behavioral: Stress and Emotions

Thoughts and Behaviors

Active Comparator group

Description:

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.

Treatment:

Behavioral: Thoughts and Behaviors

Brain and Body

Active Comparator group

Description:

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.

Treatment:

Behavioral: Brain and Body