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Fibromyalgia: Interventions for Pain and Mood Regulation

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive-behavioral
Mindfulness-acceptance
Pain Education
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Cognitive-Behavioral Therapy

    Mindfulness-acceptance Therapy

    Education

    Arm Description

    Group-based cognitive-behavioral manualized treatment

    Group-based mindfulness-acceptance manualized treatment

    Group-based manualized pain education

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 7, 2016
    Last Updated
    February 16, 2016
    Sponsor
    Arizona State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02683278
    Brief Title
    Fibromyalgia: Interventions for Pain and Mood Regulation
    Official Title
    Fibromyalgia: Interventions for Pain and Mood Regulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Arizona State University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    170 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive-Behavioral Therapy
    Arm Type
    Experimental
    Arm Description
    Group-based cognitive-behavioral manualized treatment
    Arm Title
    Mindfulness-acceptance Therapy
    Arm Type
    Experimental
    Arm Description
    Group-based mindfulness-acceptance manualized treatment
    Arm Title
    Education
    Arm Type
    Active Comparator
    Arm Description
    Group-based manualized pain education
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive-behavioral
    Intervention Description
    Seven sessions of group-based treatment targeting skills to improve dysfunctional pain-related thoughts and behaviors
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-acceptance
    Intervention Description
    Seven sessions of group-based treatment targeting skills to improve mindful awareness and acceptance of pain and stress, and increase positive emotional experiences
    Intervention Type
    Other
    Intervention Name(s)
    Pain Education
    Intervention Description
    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 Measure Information:
    Title
    Physical Functioning
    Description
    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.
    Time Frame
    Change from baseline, 6-mo followup, and 12-mo followup
    Title
    Bodily Pain
    Description
    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.
    Time Frame
    Change from baseline, 6-mo followup, and 12-mo followup
    Title
    Vitality
    Description
    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.
    Time Frame
    Change from baseline, 6-mo followup, and 12-mo followup
    Title
    Depressive symptoms
    Description
    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.
    Time Frame
    Change from baseline, 6-mo followup, 12-mo followup
    Title
    Social Functioning
    Description
    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.
    Time Frame
    Change from baseline, 6-mo followup, and 12-mo followup

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mary Davis, Ph.D.
    Organizational Affiliation
    Arizona State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Fibromyalgia: Interventions for Pain and Mood Regulation

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