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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Affective Self-Awareness workshop

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

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Southfield, Michigan, United States, 48075
      • St. John Providence Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in average pain according to the Brief Pain Inventory	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mike Hsu
• Collaborators: Blue Care Network of Michigan; St. John Providence Hospital
• Investigators: Principal Investigator: Michael C Hsu, MD, University of Michigan Chronic Pain and Fatigue Research Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: February 20, 2007
• First Submitted That Met QC Criteria: February 20, 2007
• First Posted (Estimate): February 21, 2007

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 20, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Quality of Life; Pain; Stress; Fatigue; Sleep; Randomized Controlled Trials; Affect; Stress, Psychological; Fibromyalgia; Psychophysiology
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: UM-HUM00008669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO