Pain and Stress Management for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287481
• Other study ID #: 1R01AR057808
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2010
• Last updated: March 15, 2016
• Start date: May 2011
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Wayne State University	Detroit	Michigan
United States	St. John Providence Hospital	Southfield	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Wayne State University	St. John Providence Hospital, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	SF-12		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	PROMIS Fatigue short form		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	Pittsburgh Sleep Quality Index		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	Center for Epidemiological Studies - Depression Scale		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	Generalized Anxiety Disorder - 7		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	Positive and Negative Affect Schedule		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	Satisfaction with Life Scale		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	Multiple Ability Self-Report Questionnaire		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	Patient Global Assessment of Change		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	Health Care Utilization Scale		Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment	No
Secondary	Real-time Physical Activity (Actiwatch)		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	Heart Rate Variability		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	Levels of Emotional Awareness Scale		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	Emotional Expressivity Scale		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	Ambivalence over Emotional Expression		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	Toronto Alexithymia Scale-20		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	Impact of Events Scale - Revised		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	BBCA - short form		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	Pain Catastrophizing		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	Beliefs in Pain Control Questionnaire		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	Communication Thoughts and Feelings Questionnaire		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	Experimental (thumb nail pressure) threshold and tolerance ratings		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No
Secondary	2010 ACR modified clinical criteria for FM, including widespread pain index		Baseline, post-treatment, and 6 months post-treatment (primary endpoint)	No