Clinical trial NCT00437411: Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
Official title: Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Affect
Pain
Fatigue
Sleep
Stress
Quality of Life
Stress, Psychological
Psychophysiology
Randomized Controlled Trials
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: St. John Providence Hospital
name: Blue Care Network of Michigan
First posted: 2007-02-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change in average pain according to the Brief Pain Inventory
timeFrame: 6 months
Secondary outcomes:
measure: Change in Multi-dimensional Fatigue Inventory
timeFrame: 6 months
measure: Medical Outcomes Study sleep subscale
timeFrame: 6 months
measure: Perceived Stress Scale
timeFrame: 6 months
measure: SF-36 Physical Functional Status
timeFrame: 6 months
measure: Profile of Mood States
timeFrame: 6 months
measure: Tender point count
timeFrame: 6 months
measure: Dolorimeter tender point score
timeFrame: 6 months
measure: Ascending and Multiple Random Staircase thumbnail sensitivity thresholds
timeFrame: 6 months
Other outcomes:
Locations:
city: Southfield
country: United States
facility: St. John Providence Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Chronic Pain and Fatigue Research Center
name: Michael C Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu MC, Schubiner H, Lumley MA, Stracks JS, Clauw DJ, Williams DA. Sustained pain reduction through affective self-awareness in fibromyalgia: a randomized controlled trial. J Gen Intern Med. 2010 Oct;25(10):1064-70. doi: 10.1007/s11606-010-1418-6. Epub 2010 Jun 8.