Fibromyalgia: Interventions for Pain and Mood Regulation

Fibromyalgia Clinical Trial

Official title:

Fibromyalgia: Interventions for Pain and Mood Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683278
• Other study ID #: R01AR053245
• Status: Completed
• Phase: N/A
• First received: February 7, 2016
• Last updated: February 16, 2016
• Start date: November 2008
• Est. completion date: October 2014

Study information

• 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

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Cognitive-behavioral
Seven sessions of group-based treatment targeting skills to improve dysfunctional pain-related thoughts and behaviors
• 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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Outcome

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