NCT00437411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

February 20, 2007

Last Update Submit

October 20, 2016

Conditions

Fibromyalgia

Keywords

FibromyalgiaAffectPainFatigueSleepStressQuality of LifeStress, PsychologicalPsychophysiologyRandomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

  • Change in average pain according to the Brief Pain Inventory

    6 months

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Workshop

EXPERIMENTAL

Affective Self Awareness intervention

Behavioral: Affective Self-Awareness workshop

Control

NO INTERVENTION

Waiting-list control.

Interventions

Affective Self-Awareness workshopBEHAVIORAL

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.

Workshop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. John Providence Hospital

Southfield, Michigan, 48075, United States

Location

Related Publications (1)

  • 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.

    PMID: 20532650DERIVED

MeSH Terms

Conditions

FibromyalgiaPainFatigueStress, Psychological

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Michael C Hsu, MD

    University of Michigan Chronic Pain and Fatigue Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Fellow, Clinical Lecturer

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

April 1, 2007

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

October 24, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)