Skip to main content
OpenTrials
Completed

NCT Number: NCT02683278

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavioral

Behavioral

Seven sessions of group-based treatment targeting skills to improve dysfunctional pain-related thoughts and behaviors

Mindfulness-acceptance

Behavioral

Seven sessions of group-based treatment targeting skills to improve mindful awareness and acceptance of pain and stress, and increase positive emotional experiences

Pain Education

Other

Seven sessions of group-based education to provide information regarding managing a chronic pain condition, but with no exercises to promote skill development

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Feb 17, 2016
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.