Clinical trial NCT00853138: Web-based CBT for Children With Chronic Pain
Official title: Web-based CBT for Children With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pain
Headache
Abdominal Pain
Keywords: cognitive-behavioral therapy
chronic pain
randomized controlled trial
pediatrics
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2009-03-02
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: activity limitations
timeFrame: immediately post-treatment, 3 month follow-up
Secondary outcomes:
measure: parental response to pain behaviors
timeFrame: immediately post-treatment, 3 month follow-up
measure: depressive symptoms
timeFrame: immediately post-treatment, 3 month follow-up
measure: pain intensity
timeFrame: immediately post-treatment, 3 month follow up
Other outcomes:
Locations:
Study officials:
affiliation: Seattle Children's Hospital
name: Tonya M Palermo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palermo TM, Wilson AC, Peters M, Lewandowski A, Somhegyi H. Randomized controlled trial of an Internet-delivered family cognitive-behavioral therapy intervention for children and adolescents with chronic pain. Pain. 2009 Nov;146(1-2):205-13. doi: 10.1016/j.pain.2009.07.034. Epub 2009 Aug 19.
citation: Law EF, Murphy LK, Palermo TM. Evaluating treatment participation in an internet-based behavioral intervention for pediatric chronic pain. J Pediatr Psychol. 2012 Sep;37(8):893-903. doi: 10.1093/jpepsy/jss057. Epub 2012 Apr 17.