Pain and Stress Management for Fibromyalgia

Phase 2

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Thoughts and Behaviors; Behavioral: Stress and Emotions; Behavioral: Brain and Body

• Registration Number: NCT01287481
• Lead Sponsor: Wayne State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-02-01
• Study Start: 2011-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoughts and Behaviors	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.
Stress and Emotions	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.
Brain and Body	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.

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory	Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Secondary Outcome Measures

Name	Time	Method
BBCA - short form	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)
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
Heart Rate Variability	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Pain Catastrophizing	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Positive and Negative Affect Schedule	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
Emotional Expressivity Scale	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Toronto Alexithymia Scale-20	Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
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
Ambivalence over Emotional Expression	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)
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
Real-time Physical Activity (Actiwatch)	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)
Impact of Events Scale - Revised	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)

Trial Locations

Locations (3)

Wayne State University; 🇺🇸 Detroit, Michigan, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

St. John Providence Hospital; 🇺🇸 Southfield, Michigan, United States