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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437411
• Other study ID #: UM-HUM00008669
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: October 20, 2016
• Start date: April 2007
• Est. completion date: November 2008

Study information

• Verified date: October 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

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.

Locations

Country	Name	City	State
United States	St. John Providence Hospital	Southfield	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Mike Hsu	Blue Care Network of Michigan, St. John Providence Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average pain according to the Brief Pain Inventory		6 months	No
Secondary	Change in Multi-dimensional Fatigue Inventory		6 months	No
Secondary	Medical Outcomes Study sleep subscale		6 months	No
Secondary	Perceived Stress Scale		6 months	No
Secondary	SF-36 Physical Functional Status		6 months	No
Secondary	Profile of Mood States		6 months	No
Secondary	Tender point count		6 months	No
Secondary	Dolorimeter tender point score		6 months	No
Secondary	Ascending and Multiple Random Staircase thumbnail sensitivity thresholds		6 months	No