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| Name | Class |
|---|---|
| Arizona Institute for Mental Health Research | UNKNOWN |
| Pfizer | INDUSTRY |
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The purpose of this study is to compare an online 12-module intervention designed to improve emotion regulation and social relations via mindfulness training with a 12-module program that provides information about health behaviors to individuals with fibromyalgia. The mindfulness training program is expected to produce greater day-to-day improvements than the education condition in individuals' efficacy for coping with pain and stress, positive and negative affect, and positive engagement in social relations assessed via online diaries completed each evening during the intervention period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Emotion Regulation | Experimental | 12 on-line modules targeting social and emotional regulation through mindfulness training |
|
| Placebo | Placebo Comparator | 12 on-line modules providing information regarding health behaviors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Emotion Regulation | Behavioral | 12 on-line modules provide didactic information and practice instructions re: mindfulness meditation for pain and distress |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Positive affect (10 items rated 1-5, averaged) and negative affect (10 items rated 1-5, averaged) | Trajectory of change in positive affect over the course of the trial is assessed via daily diaries. Positive and negative affect subscales are assessed daily with the Positive (10 items) and Negative (10 items) Affect Schedule (PANAS; Watson, Clark, & Tellegen, 1988). | Daily during 6-week intervention |
| Daily Pain Coping Efficacy (1 item rated 1-5) and Stress Coping Efficacy (2 item rated 1-5, averaged) | Trajectory of change over the course of the intervention via daily diary reports. Pain and stress coping efficacy (PCE and SCE) are assessed with 2 items each, with items combined to form a mean score for PCE and for SCE (Johnson, Zautra, & Davis 2006). "The first was "How satisfied are you with how you coped with your symptoms (stress)?" referring to that day, rated on a 5-point Likert scale ranging from 1=very dissatisfied to 5=very satisfied. The second item was "If you had this level of pain (stress) again, how certain are you that you would be able to cope well with its negative aspects?" rated on a 5-point Likert scale, ranging from 1=very uncertain to 5 = very certain. | Daily over 6-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Enjoyment (1 item rated 1-5) and Stressfulness (1 item rated 1-5) of Family Relations | Trajectory of change over the course of the trial via daily diaries. Daily family relations were assessed by two items asking how enjoyable (1 item) and how stressful (1 item) individuals found the time they spent with family on that day, with each item rated on a 4-point scale ranging from 1=not at all to 4 = extremely. These items were drawn from the Inventory of Small Life Events scale (Zautra, Guarnaccia, & Dohrenwend, 1986) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Tempe | Arizona | 85287-1104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23670111 | Derived | Davis MC, Zautra AJ. An online mindfulness intervention targeting socioemotional regulation in fibromyalgia: results of a randomized controlled trial. Ann Behav Med. 2013 Dec;46(3):273-84. doi: 10.1007/s12160-013-9513-7. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Health Education | Other | 12 on-line modules that provide information regarding health behaviors, but no information regarding how to put behaviors into practice |
|
| Daily during 6-week intervention |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |