Web-based CBT for Children With Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00853138
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
Tonya Palermo, 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Headache Abdominal Pain Behavioral: cognitive-behavioral therapy Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Web-based CBT for Children With Chronic Pain
Study Start Date : May 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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).
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.

Primary Outcome Measures :
  1. activity limitations [ Time Frame: immediately post-treatment, 3 month follow-up ]

Secondary Outcome Measures :
  1. parental response to pain behaviors [ Time Frame: immediately post-treatment, 3 month follow-up ]
  2. depressive symptoms [ Time Frame: immediately post-treatment, 3 month follow-up ]
  3. pain intensity [ Time Frame: immediately post-treatment, 3 month follow up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00853138

Sponsors and Collaborators
Seattle Children's Hospital
Principal Investigator: Tonya M Palermo, PhD Seattle Children's Hospital

Publications of Results:
Responsible Party: Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital Identifier: NCT00853138     History of Changes
Other Study ID Numbers: R21HD050674 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Tonya Palermo, Seattle Children's Hospital:
cognitive-behavioral therapy
chronic pain
randomized controlled trial

Additional relevant MeSH terms:
Chronic Pain
Abdominal Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive