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Completed

NCT Number: NCT00437411

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. John Providence Hospital

Southfield, Michigan, 48075, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Affective Self-Awareness workshop

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.

Primary outcomes

  1. Change in average pain according to the Brief Pain Inventory

    Time frame: 6 months

Secondary outcomes

  1. Change in Multi-dimensional Fatigue Inventory

    Time frame: 6 months

  2. Medical Outcomes Study sleep subscale

    Time frame: 6 months

  3. Perceived Stress Scale

    Time frame: 6 months

  4. SF-36 Physical Functional Status

    Time frame: 6 months

  5. Profile of Mood States

    Time frame: 6 months

  6. Tender point count

    Time frame: 6 months

  7. Dolorimeter tender point score

    Time frame: 6 months

  8. Ascending and Multiple Random Staircase thumbnail sensitivity thresholds

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mike Hsu

Other

Collaborators

  • Blue Care Network of Michigan
  • St. John Providence Hospital

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 21, 2007
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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