This trial is active, not recruiting.

Condition fibromyalgia
Treatment affective self-awareness workshop
Sponsor University of Michigan
Collaborator St. John Providence Hospital
Start date April 2007
End date December 2008
Trial size 66 participants
Trial identifier NCT00437411, UM-HUM00008669


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Affective Self Awareness intervention
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)
Waiting-list control.

Primary Outcomes

Change in average pain according to the Brief Pain Inventory
time frame: 6 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
Principal investigator Michael C Hsu, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2008.
Information provided to ClinicalTrials.gov by University of Michigan.