Web-based CBT for Children With Chronic Pain

Chronic Pain Clinical Trial

Official title:

Web-based CBT for Children With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853138
• Other study ID #: R21HD050674
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2009
• Last updated: May 26, 2015
• Start date: May 2007
• Est. completion date: May 2009

Study information

• Verified date: May 2015
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Chronic Pain
• Headache

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

References & Publications (2)

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. — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	activity limitations		immediately post-treatment, 3 month follow-up	No
Secondary	parental response to pain behaviors		immediately post-treatment, 3 month follow-up	No
Secondary	depressive symptoms		immediately post-treatment, 3 month follow-up	No
Secondary	pain intensity		immediately post-treatment, 3 month follow up	No