Clinical trial NCT01287481: Pain and Stress Management for Fibromyalgia
Official title: Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Behavioral interventions
Psychological interventions
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: St. John Providence Hospital
First posted: 2011-02-01
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.


Eligibility criteria: Inclusion Criteria:

* Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:

  * 1990 ACR criteria including tender points
  * 2010 ACR modified clinical criteria that does not include tender points

Exclusion Criteria:

* Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
* Other serious medical conditions that can impair health status independent of FM
* Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
* Alcohol/drug dependence in past 2 years
* Cognitive impairment or dementia
* Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
* Unable to fluently read or converse in English
* Planning to move from the area in the next 14 months
* Judgment of principle investigator as not appropriate for this trial or all intervention arms

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Secondary outcomes:
measure: SF-12
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
measure: PROMIS Fatigue short form
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
measure: Center for Epidemiological Studies - Depression Scale
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
measure: Generalized Anxiety Disorder - 7
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
measure: Positive and Negative Affect Schedule
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
measure: Satisfaction with Life Scale
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
measure: Multiple Ability Self-Report Questionnaire
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
measure: Patient Global Assessment of Change
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
measure: Health Care Utilization Scale
timeFrame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
measure: Real-time Physical Activity (Actiwatch)
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: Heart Rate Variability
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: Levels of Emotional Awareness Scale
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: Emotional Expressivity Scale
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: Ambivalence over Emotional Expression
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: Toronto Alexithymia Scale-20
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: Impact of Events Scale - Revised
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: BBCA - short form
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: Pain Catastrophizing
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: Beliefs in Pain Control Questionnaire
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: Communication Thoughts and Feelings Questionnaire
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: Experimental (thumb nail pressure) threshold and tolerance ratings
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
measure: 2010 ACR modified clinical criteria for FM, including widespread pain index
timeFrame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Southfield
country: United States
facility: St. John Providence Hospital
state: Michigan
Study officials:
affiliation: Wayne State University
name: Mark A Lumley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: