Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia

Wayne State University3 sites in 1 country230 target enrollmentMay 2011

ConditionsFibromyalgia

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Wayne State University
Enrollment: 230
Locations: 3
Primary Endpoint: Brief Pain Inventory
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

July 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wayne State University

Responsible Party

Principal Investigator

Mark A. Lumley

Professor

Wayne State University

Eligibility 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

Outcomes

Primary Outcomes

Brief Pain Inventory

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

Secondary Outcomes

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))
BBCA - short form(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))