Back to resultsHealing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Affective Self-Awareness workshop
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Affect, Pain, Fatigue, Sleep, Stress, Quality of Life, Stress, Psychological, Psychophysiology, Randomized Controlled Trials
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.
Sites / Locations
- St. John Providence Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Workshop
Control
Arm Description
Affective Self Awareness intervention
Waiting-list control.
Outcomes
Primary Outcome Measures
Change in average pain according to the Brief Pain Inventory
Secondary Outcome Measures
Change in Multi-dimensional Fatigue Inventory
Medical Outcomes Study sleep subscale
Perceived Stress Scale
SF-36 Physical Functional Status
Profile of Mood States
Tender point count
Dolorimeter tender point score
Ascending and Multiple Random Staircase thumbnail sensitivity thresholds
Full Information
NCT ID
NCT00437411
First Posted
February 20, 2007
Last Updated
October 20, 2016
Sponsor
Mike Hsu
Collaborators
St. John Providence Hospital, Blue Care Network of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT00437411
Brief Title
Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
Official Title
Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mike Hsu
Collaborators
St. John Providence Hospital, Blue Care Network of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Affect, Pain, Fatigue, Sleep, Stress, Quality of Life, Stress, Psychological, Psychophysiology, Randomized Controlled Trials
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Workshop
Arm Type
Experimental
Arm Description
Affective Self Awareness intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
Waiting-list control.
Intervention Type
Behavioral
Intervention Name(s)
Affective Self-Awareness workshop
Intervention Description
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 Outcome Measure Information:
Title
Change in average pain according to the Brief Pain Inventory
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Multi-dimensional Fatigue Inventory
Time Frame
6 months
Title
Medical Outcomes Study sleep subscale
Time Frame
6 months
Title
Perceived Stress Scale
Time Frame
6 months
Title
SF-36 Physical Functional Status
Time Frame
6 months
Title
Profile of Mood States
Time Frame
6 months
Title
Tender point count
Time Frame
6 months
Title
Dolorimeter tender point score
Time Frame
6 months
Title
Ascending and Multiple Random Staircase thumbnail sensitivity thresholds
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Hsu, MD
Organizational Affiliation
University of Michigan Chronic Pain and Fatigue Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. John Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20532650
Citation
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.
Results Reference
derived
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Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
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