Web-based CBT for Children With Chronic Pain
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|ClinicalTrials.gov Identifier: NCT00853138|
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : May 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Headache Abdominal Pain||Behavioral: cognitive-behavioral therapy||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Web-based CBT for Children With Chronic Pain|
|Study Start Date :||May 2007|
|Primary Completion Date :||March 2009|
|Study Completion Date :||May 2009|
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
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.
- activity limitations [ Time Frame: immediately post-treatment, 3 month follow-up ]
- parental response to pain behaviors [ Time Frame: immediately post-treatment, 3 month follow-up ]
- depressive symptoms [ Time Frame: immediately post-treatment, 3 month follow-up ]
- pain intensity [ Time Frame: immediately post-treatment, 3 month follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853138
|Principal Investigator:||Tonya M Palermo, PhD||Seattle Children's Hospital|