Fibromyalgia: Interventions for Pain and Mood Regulation

Study Overview
=================
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.

Official Title
-----------------
Fibromyalgia: Interventions for Pain and Mood Regulation

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral
* Behavioral: Mindfulness-acceptance
* Other: Pain Education


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Behavioral Therapy<br>Group-based cognitive-behavioral manualized treatment | Behavioral: Cognitive-behavioral<br>* Seven sessions of group-based treatment targeting skills to improve dysfunctional pain-related thoughts and behaviors<br>|
| Experimental: Mindfulness-acceptance Therapy<br>Group-based mindfulness-acceptance manualized treatment | Behavioral: Mindfulness-acceptance<br>* Seven sessions of group-based treatment targeting skills to improve mindful awareness and acceptance of pain and stress, and increase positive emotional experiences<br>|
| Active Comparator: Education<br>Group-based manualized pain education | Other: Pain Education<br>* Seven sessions of group-based education to provide information regarding managing a chronic pain condition, but with no exercises to promote skill development<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |