Fibromyalgia Clinical Trial
Official title:
Fibromyalgia: Interventions for Pain and Mood Regulation
Verified date | February 2016 |
Source | Arizona State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This study compares the impact of cognitive-behavioral therapy for pain (CBT-P), mindful awareness and acceptance treatment (M), and arthritis education as an active control condition (E) on mental and physical health outcomes among adults with chronic pain due to fibromyalgia (FM).
Status | Completed |
Enrollment | 170 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pain in at least 11 of 18 tenderpoints - Able to participate in study assessments and group-based meetings - Willing to be randomized to treatment condition Exclusion Criteria: - Unable to understand written and spoken English - Involved in pain-related litigation - Currently involved in psychological treatment for pain and/or mood symptoms |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Arizona State University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical Functioning | Assessed via the SF-36 physical functioning subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36: I. conceptual framework and item selection. Med Care 1992; 30(6):473-83. | Change from baseline, 6-mo followup, and 12-mo followup | No |
Primary | Bodily Pain | Assessed via the SF-36 Bodily Pain subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. conceptual framework and item selection. Med Care 1992; 30(6):473-83. | Change from baseline, 6-mo followup, and 12-mo followup | No |
Primary | Vitality | Assessed via the SF-36 Vitality subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. conceptual framework and item selection. Med Care 1992; 30(6):473-83. | Change from baseline, 6-mo followup, and 12-mo followup | No |
Primary | Depressive symptoms | Assessed via the Hamilton Depression Inventory (Reference: Reynolds WM, Kobak KA. Reliability and validity of the Hamilton Depression Inventory: A paper-and-pencil version of the Hamilton Depression Rating Scale Clinical Interview. Psychological Assessment 1995; 7(4): 472-83. | Change from baseline, 6-mo followup, 12-mo followup | No |
Primary | Social Functioning | Assessed via the SF-36 Social Functioning subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. conceptual framework and item selection. Med Care 1992; 30(6):473-83. | Change from baseline, 6-mo followup, and 12-mo followup | No |
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