Pain and Stress Management for Fibromyalgia

NCT01287481 | Completed Phase 2

• 1 other identifier: 1R01AR057808
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 3

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Behavioral interventions; Psychological interventions

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory

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

Secondary Outcomes (23)

• 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

Study Arms (3)

Stress and Emotions

EXPERIMENTAL

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

Thoughts and Behaviors

ACTIVE COMPARATOR

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

Brain and Body

ACTIVE COMPARATOR

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

Interventions

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.

Stress and Emotions

Thoughts and Behaviors BEHAVIORAL

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

Thoughts and Behaviors

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.

Brain and Body

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:
• ACR criteria including tender points
• ACR modified clinical criteria that does not include tender points

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• University of Michigan: collaborator
• St. John Providence Hospital: collaborator

Study Sites (3)

University of Michigan Medical Center

Ann Arbor, Michigan, 48106, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

St. John Providence Hospital

Southfield, Michigan, 48075, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Mark A Lumley, Ph.D.

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: February 1, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

US (3)