Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2002-10-31
2006-11-30
Brief Summary
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Detailed Description
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The purpose of this 3-year study is to use a cognitive-behavioral intervention to facilitate adoption of a wellness lifestyle in people with fibromyalgia. Specifically, we will test the efficacy of a health promotion computer program (Balance Center) used in conjunction with a wearable sensor (SenseWearTM) for developing a wellness lifestyle and improving the quality of life of adults with fibromyalgia. Balance Center software is a health promotion computer program that helps consumers to: (1) establish goals in the areas of physical activity, nutrition, participation in meaningful, productive activities, sleep, stress-reducing activities, and emotional state; (2) monitor progress toward established goals; and, (3) assess the relationship between these areas in one's daily life. In addition, based on consumer input, it offers suggestions for developing a wellness lifestyle. SenseWearTM, provides objective data about activity level and stress level for consumers to use in combination with the self-assessment data provided by the Balance Center.
In this randomized controlled clinical trial, the Experimental (Balance Center + SenseWearTM) Intervention is compared to a Usual Care, control group. Seventy-two adults (36 = Experimental; 36 = Control) with fibromyalgia will be randomized and followed for 6 weeks, exclusive of Baseline and Posttesting. The hypotheses to be tested are: Participants randomized to the Experimental Condition will demonstrate significantly (a) more physical activity, (b) a healthier, wellness lifestyle, and (c) fewer symptoms of fibromyalgia. In addition, the relationship between the decrease in fibromyalgia-related impairment on daily life and physical activity and a wellness lifestyle will be stronger at Posttesting than at Baseline in the Experimental Group, compared to the Control Group. The anticipated outcome of the intervention is more effective self-management of lifestyle and symptoms so that one can "live well with fibromyalgia."
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental
Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
Cognitive Behavior Therapy
Experimental: Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
Control
Subjects given pamphlets from the Arthritis Foundation
Cognitive Behavior Therapy
Experimental: Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
Interventions
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Cognitive Behavior Therapy
Experimental: Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* meet the American College of Rheumatology criteria for fibromyalgia
* diagnosed with fibromyalgia at least 1 year prior to admission to the study
* have sufficient vision to operate a computer
* be English speaking
* have a private telephone line
Exclusion Criteria
18 Years
ALL
No
Sponsors
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U.S. Department of Education
FED
University of Pittsburgh
OTHER
Responsible Party
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University of Pittsburgh
Principal Investigators
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Joan C. Rogers, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Subjects' homes
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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020771
Identifier Type: -
Identifier Source: org_study_id
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