Fibromyalgia
Conditions
Keywords
Fibromyalgia, Behavioral interventions, Psychological interventions
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.
Interventions
BEHAVIORALStress and Emotions
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
BEHAVIORALThoughts and Behaviors
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
BEHAVIORALBrain 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.
Sponsors
University of Michigan
St. John Providence Hospital
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brief Pain Inventory | Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Positive and Negative Affect Schedule | Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment |
| 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 |
| Health Care Utilization Scale | 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) |
| Heart Rate Variability | 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 |
| Emotional Expressivity Scale | Baseline, post-treatment, and 6 months post-treatment (primary endpoint) |
| Ambivalence over Emotional Expression | Baseline, post-treatment, and 6 months post-treatment (primary endpoint) |
| Toronto Alexithymia Scale-20 | 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) |
| BBCA - short form | Baseline, post-treatment, and 6 months post-treatment (primary endpoint) |
| Pain Catastrophizing | Baseline, post-treatment, and 6 months post-treatment (primary endpoint) |
| Beliefs in Pain Control Questionnaire | 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) |
| 2010 ACR modified clinical criteria for FM, including widespread pain index | 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) |
Countries
United States
Outcome results
None listed