Fibromyalgia: Interventions for Pain and Mood Regulation

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).

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Cognitive-behavioral; Behavioral: Mindfulness-acceptance; Other: Pain Education

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 Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Arizona State University
• Investigators: Principal Investigator: Mary Davis, Ph.D., Arizona State University

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 7, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: R01AR053245 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO