Web-based CBT for Children With Chronic Pain

NCT ID: NCT00853138

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-05-31

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.

Conditions

Chronic Pain; Headache; Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

cognitive-behavioral therapy

Intervention Type: BEHAVIORAL

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.

SMC

The standard medical care wait-list control group continued with the treatment recommendations proscribed by their pain care team.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tonya Palermo

Professor, Anesthesiology and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tonya M Palermo, PhD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

References

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/j.pain.2009.07.034. Epub 2009 Aug 19.

Reference Type: RESULT

PMID: 19695776 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22511033 (View on PubMed)

Other Identifiers

R21HD050674

Identifier Type: NIH

Identifier Source: org_study_id

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