Web-based CBT for Children With Chronic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Web-based CBT for Children With Chronic Pain

Conditions
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Chronic Pain, Headache, Abdominal Pain

Intervention / Treatment
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* Behavioral: cognitive-behavioral therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br>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). | Behavioral: cognitive-behavioral therapy<br>* 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.<br>|
| No Intervention: SMC<br>The standard medical care wait-list control group continued with the treatment recommendations proscribed by their pain care team. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activity limitations |  | immediately post-treatment, 3 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parental response to pain behaviors |  | immediately post-treatment, 3 month follow-up | 
| depressive symptoms |  | immediately post-treatment, 3 month follow-up | 
| pain intensity |  | immediately post-treatment, 3 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive-behavioral therapy, chronic pain, randomized controlled trial, pediatrics