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

Mike Hsu

Status

Completed

Conditions

Fibromyalgia

Treatments

Behavioral: Affective Self-Awareness workshop

Study type

Interventional

Funder types

Other

Identifiers

NCT00437411

UM-HUM00008669

Details and patient eligibility

About

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.

Full 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

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.