Coping Skills Training for Adolescents With Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00086047
First received: June 22, 2004
Last updated: November 1, 2013
Last verified: October 2013
Results First Received: August 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Behavioral: Coping Skills Training
Behavioral: Education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients diagnosed with juvenile fibromyalgia (ages 11-18 years)were recruited from four pediatric rheumatology clinics in the Midwestern United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened to determine eligibility for the study. if they met eligibility criteria, they were enrolled in the study and immediately randomized to one of the treatment arms.

Reporting Groups
  Description
Coping Skills Patients will receive 8 weeks of behavioral training in pain coping strategies
Education Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.

Participant Flow:   Overall Study
    Coping Skills     Education  
STARTED     57     57  
COMPLETED     50     50  
NOT COMPLETED     7     7  
Lost to Follow-up                 7                 6  
Physician Decision                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Coping Skills Patients will receive 8 weeks of behavioral training in pain coping strategies
Education Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
Total Total of all reporting groups

Baseline Measures
    Coping Skills     Education     Total  
Number of Participants  
[units: participants]
  57     57     114  
Age  
[units: participants]
     
<=18 years     57     57     114  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  15.2  ± 1.8     14.9  ± 1.7     15.0  ± 1.8  
Gender  
[units: participants]
     
Female     54     51     105  
Male     3     6     9  
Region of Enrollment  
[units: participants]
     
United States     57     57     114  



  Outcome Measures

1.  Primary:   Change in FDI (Functional Disability Inventory) Scores at End of Study   [ Time Frame: Baseline and 6 months (end of study) ]

2.  Secondary:   Pain Intensity   [ Time Frame: 9 weeks and 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Depressive Symptoms   [ Time Frame: 9 weeks and 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Susmita Kashikar-Zuck, PhD
Organization: Cincinnati Children's Hospital Medical Center
phone: 513 636 6337
e-mail: Susmita.Kashikar-Zuck@cchmc.org


No publications provided by Children's Hospital Medical Center, Cincinnati

Publications automatically indexed to this study:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00086047     History of Changes
Other Study ID Numbers: R01 AR050028, R01AR050028
Study First Received: June 22, 2004
Results First Received: August 12, 2011
Last Updated: November 1, 2013
Health Authority: United States: Federal Government