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Fibromyalgia: Interventions for Pain and Mood Regulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683278
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Mary Davis, 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).

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Cognitive-behavioral Behavioral: Mindfulness-acceptance Other: Pain Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fibromyalgia: Interventions for Pain and Mood Regulation
Study Start Date : November 2008
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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




Primary Outcome Measures :
  1. Physical Functioning [ Time Frame: 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.

  2. Bodily Pain [ Time Frame: 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.

  3. Vitality [ Time Frame: 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.

  4. Depressive symptoms [ Time Frame: 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.

  5. Social Functioning [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683278


Sponsors and Collaborators
Arizona State University
Investigators
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Principal Investigator: Mary Davis, Ph.D. Arizona State University
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Responsible Party: Mary Davis, Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT02683278    
Other Study ID Numbers: R01AR053245 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases