Fibromyalgia
Conditions
Brief summary
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).
Detailed description
Both cognitive-behavioral and mindful-acceptance based treatments impact pain and disability in people with chronic pain conditions like fibromyalgia. However, these treatments target different mechanisms. The focus of CBT is on helping individuals manage their thoughts and behaviors related to pain. In contrast, the focus of M is on improving individuals' ability be aware of and accept their experiences, and to develop their positive emotional resources.
Interventions
BEHAVIORALCognitive-behavioral
Seven sessions of group-based treatment targeting skills to improve dysfunctional pain-related thoughts and behaviors
BEHAVIORALMindfulness-acceptance
Seven sessions of group-based treatment targeting skills to improve mindful awareness and acceptance of pain and stress, and increase positive emotional experiences
OTHERPain Education
Seven sessions of group-based education to provide information regarding managing a chronic pain condition, but with no exercises to promote skill development
Sponsors
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Functioning | Change from baseline, 6-mo followup, and 12-mo followup | 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. |
| Bodily Pain | Change from baseline, 6-mo followup, and 12-mo followup | 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. |
| Vitality | Change from baseline, 6-mo followup, and 12-mo followup | 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. |
| Depressive symptoms | Change from baseline, 6-mo followup, 12-mo followup | 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. |
| Social Functioning | Change from baseline, 6-mo followup, and 12-mo followup | 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. |
Outcome results
None listed