Fibromyalgia: Interventions for Pain and Mood Regulation

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Cognitive-behavioral; Behavioral: Mindfulness-acceptance; Other: Pain Education

• Registration Number: NCT02683278
• Lead Sponsor: Arizona State University

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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-02
• Study First Submitted: 2016-02-07
• Study First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Study First Posted: 2016-02-17
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioral Therapy	Cognitive-behavioral	Group-based cognitive-behavioral manualized treatment
Mindfulness-acceptance Therapy	Mindfulness-acceptance	Group-based mindfulness-acceptance manualized treatment
Education	Pain Education	Group-based manualized pain education

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.