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Web-Based CBT for Children With Chronic Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00853138
First received: February 26, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

The purpose of this study is to develop and evaluate the feasibility and effectiveness of a web-based (i.e., internet) treatment approach for providing psychological treatment to reduce pain and improve functioning in children and adolescents with chronic pain.


Condition Intervention Phase
Chronic Pain
Headache
Abdominal Pain
Behavioral: cognitive-behavioral therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Web-Based CBT for Children With Chronic Pain

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • activity limitations [ Time Frame: immediately post-treatment, 3 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • parental response to pain behaviors [ Time Frame: immediately post-treatment, 3 month follow-up ] [ Designated as safety issue: No ]
  • depressive symptoms [ Time Frame: immediately post-treatment, 3 month follow-up ] [ Designated as safety issue: No ]
  • pain intensity [ Time Frame: immediately post-treatment, 3 month follow up ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: May 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT
cognitive-behavioral therapy
Behavioral: cognitive-behavioral therapy

In addition to standard medical care, the children and parents in the family CBT condition will also receive education about chronic pain, pain behaviors and operant strategies as well as training in coping skills using an interactive, engaging format on the Internet.

The Internet site will consist of three main sections: child treatment modules, parent treatment modules, and diary tracking. All users will complete 8 treatment modules (one per week) over the 8-week treatment period. Each module will require approximately 30-40 minutes to complete. There is separate specific content of the intervention for child users and for parent users.

Assignments are incorporated into each module for the participant to work on during the treatment week.

No Intervention: SMC
standard medical care wait-list control group

Detailed Description:

Chronic pain is an important problem for children and adolescents owing to its high prevalence rate and significant impact on children's mood, daily functioning, and overall quality of life. Effective psychological treatments have been developed to change behaviors and thoughts important in the child's ability to cope with chronic pain. However, the majority of children do not have access to these treatments due to a variety of barriers such as geographical distance from pediatric pain treatment centers.

The purpose of this study is to develop a more accessible method of delivering effective psychological treatment to reduce pain and increase function in children. Children with chronic headache, abdominal, or musculoskeletal pain will be randomized to either receive the web-based treatment right away or to be in a wait-list control condition and receive the treatment 8 weeks later. Both groups of children will continue to receive clinical care through specialty medical clinics. Children's level of pain, their ability to perform, daily functional activities, and overall quality of life will be evaluated before treatment begins, immediately after treatment, and at a 3 month follow up.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic headache, abdominal, and/or musculoskeletal pain present over the previous 3 months
  • interference from pain in at least one area of daily functioning.

Exclusion Criteria:

  • serious comorbid chronic condition in the patient (e.g., diabetes, cancer)
  • non-English speaking
  • previous participation in cognitive-behavioral therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853138

Sponsors and Collaborators
Investigators
Principal Investigator: Tonya M Palermo, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Tonya Palermo, Ph.D., Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00853138     History of Changes
Other Study ID Numbers: R21HD050674
Study First Received: February 26, 2009
Last Updated: February 26, 2009
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
cognitive-behavioral therapy
chronic pain
randomized controlled trial
pediatrics

Additional relevant MeSH terms:
Abdominal Pain
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 24, 2014