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

NCT ID: NCT00437411

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-11-30

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

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Workshop

Affective Self Awareness intervention

Group Type: EXPERIMENTAL

Affective Self-Awareness workshop

Intervention Type: BEHAVIORAL

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.

Control

Waiting-list control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. John Providence Hospital

UNKNOWN

Sponsor Role: collaborator

Blue Care Network of Michigan

OTHER

Sponsor Role: collaborator

Mike Hsu

OTHER

Sponsor Role: lead

Responsible Party

Mike Hsu

Research Fellow, Clinical Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael C Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Chronic Pain and Fatigue Research Center

Locations

St. John Providence Hospital

Southfield, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20532650 (View on PubMed)

Other Identifiers

UM-HUM00008669

Identifier Type: -

Identifier Source: org_study_id