Coping Skills Training for Adolescents With Fibromyalgia

August 23, 2017 updated by: Children's Hospital Medical Center, Cincinnati

Randomized Clinical Trial in Juvenile Fibromyalgia

Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and difficulty in an adolescent's day-to-day activities. The purpose of this study is to determine whether coping skills training, when combined with usual medical care, can reduce pain and disability in adolescents with fibromyalgia.

Study hypotheses: 1) Adolescents who receive coping skills training combined with their usual medical care will show significantly greater reductions in functional disability, pain, and depressive symptoms at the end of the acute treatment phase than adolescents who receive fibromyalgia education with their usual medical care. 2) Adolescents who receive coping skills training with their usual medical care will show significantly lower levels of functional disability, pain, and depressive symptoms at the end of a six-month maintenance phase than adolescents who receive fibromyalgia education with their usual medical care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Juvenile Primary Fibromyalgia Syndrome (JPFS) is a debilitating chronic pain condition that occurs in adolescence and is characterized by persistent pain, multiple tender points, sleep difficulty, and fatigue. The cause of JPFS is unknown and there is no known cure. Children and adolescents with JPFS have difficulty with daily functioning, miss a great deal of school, and experience increased emotional distress compared to their peers. Fibromyalgia syndrome appears to be resistant to treatment in adulthood, so early behavioral treatment for JPFS with long-term beneficial effects would be useful. This study will evaluate the efficacy of coping skills training (CST) when combined with usual medical care in reducing functional disability, pain intensity, and depressive symptoms in adolescents with JPFS. This study will also determine whether improvements can be sustained long-term.

This study will last 34 weeks. Participants will be recruited from three pediatric rheumatology clinics. Patients will be randomly assigned to one of two groups: CST plus usual medical care or education plus usual medical care. There will be 6 medical visits, spaced 4 to 5 weeks apart. In addition, patients will attend 8 individual sessions of CST or education over the first 8 weeks of the study. CST sessions will include training in cognitive-behavioral techniques of pain management for the adolescent and behavioral management techniques for their parents. Education sessions will include education on fibromyalgia and discussion about lifestyle issues, but no training in pain management procedures.

Patients will be evaluated at Week 9 and will be followed for an additional 6-month maintenance phase. During this maintenance phase, adolescents will continue to receive their usual medical care and will attend 2 additional sessions of CST or education. There will be one final evaluation at the end of the maintenance phase.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kosair Charities Pediatric Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation, Division of Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of JPFS based upon widespread pain for over 3 months, at least 5 tender points, and associated features such as sleep difficulty, fatigue, and abdominal discomfort
  • Average pain intensity greater than 4 on the Visual Analog Scale
  • Functional disability score greater than 7
  • Stable medications for 8 weeks prior to study entry

Exclusion Criteria:

  • Other chronic rheumatic diseases, such as juvenile rheumatoid arthritis or lupus
  • Significant developmental delay or impairments, such as autism, cerebral palsy, or mental retardation
  • Present or lifetime psychiatric diagnosis that meets DSM-IV criteria for panic disorder, bipolar disorder, major depressive disorder, or psychosis
  • Opioid medications are disallowed when used on an ongoing basis for treatment of fibromyalgia pain

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coping Skills
Patients will receive 8 weeks of behavioral training in pain coping strategies
Behavioral: Coping Skills Training
8 weekly sessions of behavioral treatment
Other Names:
  • cognitive-behavioral therapy
Active Comparator: Education
Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
Behavioral: Education
8 weekly sessions of fibromyalgia education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FDI (Functional Disability Inventory) Scores at End of Study
Time Frame: Baseline and 6 months (end of study)
Functional disability score is measured by the Functional Disability Inventory (FDI)which assesses ability to engage in usual physical, social and recreational activities. Scores range from 0=no disability to 60 = extreme disability and and are interpreted as No/Mild disability (0-12); Moderate Disability (13-29) and Severe Disability (30-60)
Baseline and 6 months (end of study)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain Intensity
Time Frame: 9 weeks and 6 months
9 weeks and 6 months
Depressive Symptoms
Time Frame: 9 weeks and 6 months
9 weeks and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 22, 2004

First Submitted That Met QC Criteria

June 22, 2004

First Posted (Estimate)

June 23, 2004

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AR050028 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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