Coping Skills Training for Adolescents With Fibromyalgia

NCT00086047 | Completed Phase 3 Results DMC

• 1 other identifier: R01AR050028
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Juvenile Fibromyalgia Syndrome; JPFS; Fibromyalgia; Chronic Pain; Pediatric Pain; Juvenile Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change in FDI (Functional Disability Inventory) Scores at 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 Outcomes (2)

• Pain Intensity

  9 weeks and 6 months

• Depressive Symptoms

  9 weeks and 6 months

Study Arms (2)

Coping Skills

EXPERIMENTAL

Patients will receive 8 weeks of behavioral training in pain coping strategies

Behavioral: Coping Skills Training

Education

ACTIVE COMPARATOR

Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.

Behavioral: Education

Interventions

Coping Skills Training BEHAVIORAL

8 weekly sessions of behavioral treatment

Also known as: cognitive-behavioral therapy

Coping Skills

Education BEHAVIORAL

8 weekly sessions of fibromyalgia education

Education

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (3)

Kosair Charities Pediatric Center

Louisville, Kentucky, 40202, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Cleveland Clinic Foundation, Division of Pediatrics

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• Kashikar-Zuck S, Ting TV, Arnold LM, Bean J, Powers SW, Graham TB, Passo MH, Schikler KN, Hashkes PJ, Spalding S, Lynch-Jordan AM, Banez G, Richards MM, Lovell DJ. Cognitive behavioral therapy for the treatment of juvenile fibromyalgia: a multisite, single-blind, randomized, controlled clinical trial. Arthritis Rheum. 2012 Jan;64(1):297-305. doi: 10.1002/art.30644.

  PMID: 22108765 RESULT

• Joffe NE, Lynch-Jordan A, Ting TV, Arnold LM, Hashkes PJ, Lovell DJ, Passo MH, Powers SW, Schikler KN, Kashikar-Zuck S. Utility of the PedsQL rheumatology module as an outcome measure in juvenile fibromyalgia. Arthritis Care Res (Hoboken). 2013 Nov;65(11):1820-7. doi: 10.1002/acr.22045.

  PMID: 23686969 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Cognitive Behavioral Therapy; Educational Status

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Susmita Kashikar-Zuck, PhD
• Organization: Cincinnati Children's Hospital Medical Center

Susmita.Kashikar-Zuck@cchmc.org

513 636 6337

Study Officials

• Susmita Kashikar-Zuck, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2004
• First Posted: June 23, 2004
• Study Start: July 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 20, 2017
• Results First Posted: November 6, 2013

Record last verified: 2017-08

Locations

US (3)