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Pain and Stress Management for Fibromyalgia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Michigan
St. John Providence Hospital
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University
ClinicalTrials.gov Identifier:
NCT01287481
First received: November 2, 2010
Last updated: May 14, 2014
Last verified: May 2014

November 2, 2010
May 14, 2014
May 2011
May 2014   (final data collection date for primary outcome measure)
Brief Pain Inventory [ Time Frame: Data collected at baseline and at follow-up 9 months post randomization, which is the primary endpoint. We plan to have a secondary endpoint (subset of measures) assessment 6 months and 12 months after randomization. ] [ Designated as safety issue: No ]
Brief Pain Inventory [ Time Frame: follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01287481 on ClinicalTrials.gov Archive Site
  • SF-12 [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
  • PROMIS Fatigue short form [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
  • Center for Epidemiological Studies - Depression Scale [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
  • Generalized Anxiety Disorder - 7 [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
  • Positive and Negative Affect Schedule [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
  • Satisfaction with Life Scale [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
  • Multiple Ability Self-Report Questionnaire [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Change [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
  • Health Care Utilization Scale [ Time Frame: Baseline, post treatment (3 months post randomization) and two follow-up timepoints (9 and 12 months post randomization) ] [ Designated as safety issue: No ]
  • Real-time Physical Activity (Actiwatch) [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Heart Rate Variability [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Levels of Emotional Awareness Scale [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Emotional Expressivity Scale [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Ambivalence over Emotional Expression [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Toronto Alexithymia Scale-20 [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Impact of Events Scale - Revised [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • BBCA - short form [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Pain Catastrophizing [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Beliefs in Pain Control Questionnaire [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Communication Thoughts and Feelings Questionnaire [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Experimental (thumb nail pressure) threshold and tolerance ratings [ Time Frame: Baseline, post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • SF-12 [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • PROMIS Fatigue short form [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Pittsburg Sleep Quality Index [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Center for Epidemiological Studies - Depression Scale [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Generalized Anxiety Disorder - 7 [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Positive and Negative Affect Schedule [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Satisfaction with Life Scale [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Multiple Ability Self-Report Questionnaire [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Change [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Health Care Utilization Scale [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Real-time Physical Activity (Actiwatch) [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Heart Rate Variability [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Levels of Emotional Awareness Scale [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Emotional Expressivity Scale [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Ambivalence over Emotional Expression [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Toronto Alexithymia Scale-20 [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Impact of Events Scale - Revised [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • BBCA - short form [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Pain Catastrophizing [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Beliefs in Pain Control Questionnaire [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
  • Communication Thoughts and Feelings Questionnaire [ Time Frame: post treatment (3 months post randomization) and follow-up (9 months post randomization) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pain and Stress Management for Fibromyalgia
Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia

This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Fibromyalgia
  • Behavioral: Stress and Emotions
    Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
  • Behavioral: Thoughts and Behaviors
    Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
  • Behavioral: Brain and Body
    Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.
  • Experimental: Stress and Emotions
    Seeks to reduce stress and physical symptoms by helping individual become aware of their emotions, express them, and resolve emotional difficulties. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
    Intervention: Behavioral: Stress and Emotions
  • Active Comparator: Thoughts and Behaviors
    Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms of fibromyalgia. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
    Intervention: Behavioral: Thoughts and Behaviors
  • Active Comparator: Brain and Body
    Seeks to help individuals improve health by educating about fibromyalgia so that one can better understand and more effectively communicate about their health. It will explain the latest scientific information about fibromyalgia, including its causes, the role of the nervous system and body, various medical and alternative treatments, and how to understand research findings.
    Intervention: Behavioral: Brain and Body
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
270
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:

    • 1990 ACR criteria including tender points
    • 2010 ACR modified clinical criteria that does not include tender points

Exclusion Criteria:

  • Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
  • Other serious medical conditions that can impair health status independent of FM
  • Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
  • Alcohol/drug dependence in past 2 years
  • Cognitive impairment or dementia
  • Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
  • Unable to fluently read or converse in English
  • Planning to move from the area in the next 14 months
  • Judgment of principle investigator as not appropriate for this trial or all intervention arms
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01287481
1R01AR057808
No
Mark A. Lumley, Wayne State University
Wayne State University
  • University of Michigan
  • St. John Providence Hospital
Principal Investigator: Mark A Lumley, Ph.D. Wayne State University
Wayne State University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP