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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| St. John Providence Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress and Emotions | Experimental | 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. |
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| Thoughts and Behaviors | Active Comparator | 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. |
|
| Brain and Body | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress and Emotions | Behavioral | Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory | Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Lumley, Ph.D. | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Medical Center | Ann Arbor | Michigan | 48106 | United States | ||
| Wayne State University |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Thoughts and Behaviors | Behavioral | Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking. |
|
| Brain and Body | Behavioral | Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments. |
|
| 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) |
| Levels of Emotional Awareness Scale | Baseline, post-treatment, and 6 months post-treatment (primary endpoint) |
| 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) |
| Detroit |
| Michigan |
| 48202 |
| United States |
| St. John Providence Hospital | Southfield | Michigan | 48075 | United States |
| D009422 |
| Nervous System Diseases |