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

This study has been completed.
Sponsor:
Collaborators:
St. John Providence Hospital
Blue Care Network of Michigan
Information provided by (Responsible Party):
Mike Hsu, University of Michigan
ClinicalTrials.gov Identifier:
NCT00437411
First received: February 20, 2007
Last updated: October 20, 2016
Last verified: October 2016
  Purpose
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 Intervention
Fibromyalgia Behavioral: Affective Self-Awareness workshop

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mike Hsu, University of Michigan:

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

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

Enrollment: 66
Study Start Date: April 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: February 20, 2007
Last Updated: October 20, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 23, 2017