Internet Intervention for Adolescents With Chronic Pain

Seattle Children's Healthcare System

Status and phase: Completed; Phase 2

Conditions: Chronic Pain; Headache; Abdominal Pain

Treatments: Behavioral: Online Behavioral Intervention; Other: Education: Online Patient Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01316471

R01HD062538-01A1

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of a web-based (i.e., internet) behavioral program to reduce pain and improve functioning in children and adolescents with chronic pain. We hypothesize that children and adolescents in families that receive the web-based behavioral program will report reduced pain levels and improved daily functioning compared to children and their parents who receive online patient education.

Full description

An estimated 15% to 30% of otherwise healthy children and adolescents suffer from recurrent or chronic pain such as headache, abdominal pain, and musculoskeletal pain. Chronic pain has a significant impact on children's mood, daily functioning, and overall quality of life. Effective behavioral interventions have been developed to increase positive coping behaviors. However, most children do not have access to these interventions due to a variety of barriers such as distance from pediatric pain treatment centers. We have developed an online behavioral intervention called Web-based Management of Adolescent Pain (Web-MAP), and our preliminary findings indicated that children in families that received this intervention experienced significant improvements in their pain level and daily functioning compared to children who did not receive the intervention (Palermo et al., 2009). The purpose of this study is to extend these findings by: 1) recruiting families from other medical centers, 2) determining whether the benefits of online behavioral intervention are maintained 6- and 12-months after the intervention has been completed, 3) evaluating additional outcomes such as parent responses to pain and child sleep quality, anxiety, depression, and health service use, 4) comparing results from online behavioral intervention to online patient education.

Enrollment: 273 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Literate in English
• Age 11-17 years
• Pain present for at least 3 months duration
• Pain occurs at least 1 time per week and interferes with daily functioning
• Pain is not related to a chronic disease
• Receiving evaluation or treatment in a pediatric pain clinic
• Has access to a computer, the Internet, and a phone

Exclusion criteria

• A serious comorbid chronic condition in the patient (e.g., diabetes, arthritis, cancer).
• Non-English speaking
• More than 4 sessions of CBT for pain management in the 6 months prior to the time of screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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273 participants in 2 patient groups

Online Behavioral Intervention

Experimental group

Description:

In addition to standard medical care, children and parents in the online behavioral intervention will receive access to the full web-based program including education about chronic pain, training in behavioral and cognitive coping skills, instruction in increasing activity participation, and education about pain behaviors and parental operant strategies using an engaging, interactive format on the Internet.

Treatment:

Behavioral: Online Behavioral Intervention

Online Patient Education

Active Comparator group

Description:

The Online Patient Education group will serve as an attention control condition. In addition to standard medical care, children and parents will be provided with access to a modified version of the study website that will provide information from publicly available educational websites about pediatric chronic pain management.

Treatment:

Other: Education: Online Patient Education