Fibromyalgia Clinical Trial
Official title:
Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Wayne State University | St. John Providence Hospital, University of Michigan |
United States,
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 |
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