Promoting Health in People With Fibromyalgia

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