Web-based CBT for Children With Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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: CBT
Cognitive-behavioral therapy delivered via the internet in eight treatment modules for children (education, stress and negative emotions, deep breathing and relaxation, distraction, cognitive skills, sleep hygiene and lifestyle, staying active, relapse prevention) and eight treatment modules for parents (education, stress and negative emotions, operant strategies I, operant strategies II, modeling, sleep hygiene and lifestyle, communication, relapse prevention).
|
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
The standard medical care wait-list control group continued with the treatment recommendations proscribed by their pain care team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
activity limitations
Time Frame: immediately post-treatment, 3 month follow-up
|
immediately post-treatment, 3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
parental response to pain behaviors
Time Frame: immediately post-treatment, 3 month follow-up
|
immediately post-treatment, 3 month follow-up
|
|
depressive symptoms
Time Frame: immediately post-treatment, 3 month follow-up
|
immediately post-treatment, 3 month follow-up
|
|
pain intensity
Time Frame: immediately post-treatment, 3 month follow up
|
immediately post-treatment, 3 month follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tonya M Palermo, PhD, Seattle Children's Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21HD050674 (U.S. NIH Grant/Contract)
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