Promoting Health in People With Fibromyalgia

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University of Pittsburgh

Status

Completed

Conditions

Fibromyalgia

Treatments

Behavioral: Cognitive Behavior Therapy

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00167271
020771

Details and patient eligibility

About

Body worn sensors and the Internet can be used to self-monitor daily behavior and promote a healthier lifestyle in women with fibromyalgia.

Full description

Fibromyalgia is among the most common diffuse pain syndromes, affecting about 1 of every 10 rheumatology patients. People with fibromyalgia experience widespread chronic pain and fatigue that negatively influences their activity participation (causes disability) and overall quality of life. 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."

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • be at least 18 years of age
  • 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

live beyond a 40 mile radius of Pittsburgh

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Experimental
Experimental group
Description:
Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
Treatment:
Behavioral: Cognitive Behavior Therapy
Control
Active Comparator group
Description:
Subjects given pamphlets from the Arthritis Foundation
Treatment:
Behavioral: Cognitive Behavior Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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