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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Affective Self-Awareness workshop


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Workshop<br>Affective Self Awareness intervention | Behavioral: Affective Self-Awareness workshop<br>* 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.<br>|
| No Intervention: Control<br>Waiting-list control. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Profile of Mood States |  | 6 months | 
| Tender point count |  | 6 months | 
| Dolorimeter tender point score |  | 6 months | 
| Ascending and Multiple Random Staircase thumbnail sensitivity thresholds |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Affect, Pain, Fatigue, Sleep, Stress, Quality of Life, Stress, Psychological, Psychophysiology, Randomized Controlled Trials