Pain and Stress Management for Fibromyalgia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Fibromyalgia	Behavioral: Stress and Emotions Behavioral: Thoughts and Behaviors Behavioral: Brain and Body	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Fibromyalgia

U.S. FDA Resources

Further study details as provided by Wayne State University:

Primary Outcome Measures:

Brief Pain Inventory [ Time Frame: Data collected at baseline and at follow-up 9 months post randomization, which is the primary endpoint. We plan to have a secondary endpoint (subset of measures) assessment 6 months and 12 months after randomization. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	270
Study Start Date:	May 2011
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287481

Contacts

Contact: Nancy Lockhart, MSN

313-577-2258

nlockhart@wayne.edu

Locations

United States, Michigan
University of Michigan Medical Center	Recruiting
Ann Arbor, Michigan, United States, 48106
Principal Investigator: David A. Williams, Ph.D.
Wayne State University	Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Mark A. Lumley, Ph.D.
St. John Providence Hospital	Not yet recruiting
Southfield, Michigan, United States, 48075
Principal Investigator: Howard H. Schubiner, MD

Sponsors and Collaborators

Wayne State University

University of Michigan

St. John Providence Hospital

Investigators

Principal Investigator:

Mark A Lumley, Ph.D.

Wayne State University

More Information

No publications provided

Responsible Party:	Mark A. Lumley, Professor, Wayne State University
ClinicalTrials.gov Identifier:	NCT01287481 History of Changes
Other Study ID Numbers:	1R01AR057808
Study First Received:	November 2, 2010
Last Updated:	November 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Wayne State University:

Fibromyalgia
Behavioral interventions
Psychological interventions

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013