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Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT00437411
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : October 24, 2016
Sponsor:
Collaborators:
St. John Providence Hospital
Blue Care Network of Michigan
Information provided by (Responsible Party):
Mike Hsu, University of Michigan

Brief Summary:
The investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. The investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Affective Self-Awareness workshop Not Applicable

Detailed Description:

The affective self-awareness approach presumes that many chronic pain states, such as fibromyalgia (FM), can be effectively treated by encouraging self-awareness of emotional tension. While anecdotally effective in selected patients, this approach has thus far not been tested in a randomized controlled trial. Our purpose is to determine whether an affective self-awareness approach significantly improves pain, tenderness, and other FM symptoms in a random sample of FM patients; and to determine what psychosocial factors predict a favorable response.

Comparisons: changes in ratings of pain, tenderness, and other symptoms between two arms of the study:

  • three weekly 2-hour small-group meetings supplemented with daily writing and meditative exercises to enhance affective self-awareness
  • usual care

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
Study Start Date : April 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Workshop
Affective Self Awareness intervention
Behavioral: Affective Self-Awareness workshop
Affective Self Awareness intervention: 90 minute face-to-face consultation with the treating physician, then three 2-hour weekly small-group workshops involving education regarding Mind-Body connections, written emotional expression, meditation, and self-affirmation practices.
No Intervention: Control
Waiting-list control.



Primary Outcome Measures :
  1. Change in average pain according to the Brief Pain Inventory [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in Multi-dimensional Fatigue Inventory [ Time Frame: 6 months ]
  2. Medical Outcomes Study sleep subscale [ Time Frame: 6 months ]
  3. Perceived Stress Scale [ Time Frame: 6 months ]
  4. SF-36 Physical Functional Status [ Time Frame: 6 months ]
  5. Profile of Mood States [ Time Frame: 6 months ]
  6. Tender point count [ Time Frame: 6 months ]
  7. Dolorimeter tender point score [ Time Frame: 6 months ]
  8. Ascending and Multiple Random Staircase thumbnail sensitivity thresholds [ Time Frame: 6 months ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • fibromyalgia, as defined by American College of Rheumatology 1990 criteria.
  • at least 18 years of age.
  • have access to transportation to and from Providence Hospital, Southfield, MI.

Exclusion Criteria:

  • co-morbid medical conditions capable of causing a worsening of physical functional status independent of FM, including morbid obesity, autoimmune diseases, cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), pregnancy, and malignancy within the preceding 2 years.
  • any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), post-traumatic stress disorder, current suicide risk or history of suicide attempt, or substance abuse within 2 years. Note: Subjects with mood or anxiety disorders otherwise will not be excluded.
  • changes in medication regimen within one month prior to enrollment.

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): NCT00437411


Locations
United States, Michigan
St. John Providence Hospital
Southfield, Michigan, United States, 48075
Sponsors and Collaborators
Mike Hsu
St. John Providence Hospital
Blue Care Network of Michigan
Investigators
Principal Investigator: Michael C Hsu, MD University of Michigan Chronic Pain and Fatigue Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mike Hsu, Research Fellow, Clinical Lecturer, University of Michigan
ClinicalTrials.gov Identifier: NCT00437411     History of Changes
Other Study ID Numbers: UM-HUM00008669
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mike Hsu, University of Michigan:
Fibromyalgia
Affect
Pain
Fatigue
Sleep
Stress
Quality of Life
Stress, Psychological
Psychophysiology
Randomized Controlled Trials

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases