Web-based CBT for Children With Chronic Pain

Phase 2

Completed

• Conditions: Chronic Pain; Abdominal Pain; Headache
• Interventions: Behavioral: cognitive-behavioral therapy

• Registration Number: NCT00853138
• Lead Sponsor: Seattle Children's Hospital

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Primary Completion: 2009-03
• Study First Posted: 2009-03-02
• Study Completion: 2009-05
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT	cognitive-behavioral therapy	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).

Primary Outcome Measures

Name	Time	Method
activity limitations	immediately post-treatment, 3 month follow-up

Secondary Outcome Measures

Name	Time	Method
depressive symptoms	immediately post-treatment, 3 month follow-up
pain intensity	immediately post-treatment, 3 month follow up
parental response to pain behaviors	immediately post-treatment, 3 month follow-up