Completed

Behavioral Preparation for Treating Fibromyalgia

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What is being tested

Behavioral coping skills training plus physical therapy

+ Stress management education plus physical therapy

Behavioral
Who is being recruted

Fibromyalgia+4

+ Muscular Diseases

+ Musculoskeletal Diseases

From 21 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2005
See protocol details

Summary

Principal SponsorUniversity of Utah
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2005

Actual date on which the first participant was enrolled.

FM is a chronic pain condition causing discomfort and disability; there is no known cure. Research suggests that combination treatment of physical therapy, fibromyalgia education, and stress management education is helpful for many patients with this condition. However, how much benefit patients get from such therapies varies greatly. This study will evaluate the effectiveness of behavioral preparation, stress management education, and fibromyalgia and coping education each in combination with physical therapy and physical education, in relieving the symptoms of FM. The study will last approximately 15 months. Participants will undergo a comprehensive assessment including medical, physical, and psychological evaluations. Blood will be collected to measure participants' serotonin levels; participants will also be asked to complete several questionnaires to assess their FM symptoms and joint function. For a 7-day period prior to starting behavioral interventions, participants will be asked to carry a personal-size digit assistant (PDA) that will ask them questions about their quality of life three times a day . During this time, they will also continuously wear a wristwatch-like device to measure functional movement and quality of sleep. For 10 weeks, participants will undergo therapy sessions of one of the behavioral interventions (behavioral preparation, stress management education, or fibromyalgia and coping education) along with physical therapy and physical education. During Weeks 1 through 4, participants will receive 2 hours of their assigned intervention. During Weeks 5 and 6, they will receive 1 hour of their assigned intervention and 1 hour of physical therapy. During Weeks 7 through 9, they will receive 1 hour of physical therapy and 1 hour of physical education. During Week 10, they will receive 1 hour of their assigned intervention and 1 hour of physical therapy.

Official TitleBehavioral Preparation for Treating Fibromyalgia 
NCT00088777
Principal SponsorUniversity of Utah
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FibromyalgiaMuscular DiseasesMusculoskeletal DiseasesMyofascial Pain SyndromesNervous System DiseasesNeuromuscular DiseasesRheumatic Diseases

Criteria

Inclusion Criteria: * Diagnosis of fibromyalgia * Have not been actively exercising (e.g., aerobic activity such as cycling, jogging, climbing, rowing, and muscle strengthening activity) for more than 30 minutes per week Exclusion Criteria: * Other progressive disease * Plan to have surgery during the next year * Pregnancy or planning to become pregnant during the next year * Resting diastolic blood pressure greater than 115 mm Hg or resting systolic blood pressure greater than 200 mg Hg * Cardiovascular diseases * Serious psychopathology (e.g., diagnoses of psychosis, organic mental disorder, or dissociative disorder; active suicidal intent; inpatient admission to psychiatric ward or incidence of self-injurious behaviors in the past year) * Non-IV substance abuse within the last 2 years, or history of recreational IV drug use * Other rheumatologic disorder (e.g., rheumatoid arthritis) * Neuropathic pain * Pain associated with terminal illness, acute pain, or pain associated with specific organ damage (e.g., stomach ulcer)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Utah, Pain Research and Management Center

Salt Lake City, United StatesSee the location
CompletedOne Study Center