Internet Intervention for Adolescents With Chronic Pain

Web-MAP 2: Internet Intervention for Adolescents With Chronic Pain

Sponsors

Lead Sponsor: Seattle Children's Hospital

Source Seattle Children's Hospital
Brief Summary

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.

Detailed 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.

Overall Status Completed
Start Date May 2011
Completion Date November 2015
Primary Completion Date November 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Activity limitations pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Pain intensity pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Secondary Outcome
Measure Time Frame
Depression and pain-specific anxiety pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Treatment Satisfaction Immediately Post-Treatment, 6-month follow-up, 12-month follow-up
Parental Response to Pain Behavior pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Sleep Quality pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Health service Use pre-treatment, 12-month follow-up
Miscarried Helping pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Enrollment 273
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Online Behavioral Intervention

Description: The online behavioral intervention is travel-themed and participants visit 8 destinations (1 per week) designed to take 30 min each to complete. The destinations serve as an online analog for the weekly sessions used when delivering behavioral interventions face-to-face. The 8 child destinations include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) relaxation and distraction skills, 4) school, 5) cognitive skills, 6) sleep hygiene and lifestyle, 7) staying active, and 8) relapse prevention. The eight parent destinations include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I, 4) operant strategies II, 5) modeling, 6) sleep hygiene and lifestyle, 7) communication, and 8) relapse prevention.

Arm Group Label: Online Behavioral Intervention

Other Name: Internet Intervention

Intervention Type: Other

Intervention Name: Education: Online Patient Education

Description: The purpose of the online patient education group is to control for time, attention, and computer usage. Children and parents will be provided with access to a modified version of the study website that will provide links to information from publicly available educational websites about pediatric chronic pain management. Children and parents will log onto the web program weekly at the same interval as the Online Behavioral Intervention group. Children and parents will be asked to view 3 links each week and then report a few details pertaining to the content of what they viewed.

Arm Group Label: Online Patient Education

Other Name: Online Attention Control

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 11 Years

Maximum Age: 17 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Tonya M. Palermo, Ph.D. Principal Investigator University of Washington Medical School
Location
Facility: Seattle Children's Hospital
Location Countries

United States

Verification Date

October 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seattle Children's Hospital

Investigator Full Name: Tonya Palermo

Investigator Title: Professor, Anesthesiology and Pain Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Online Behavioral Intervention

Type: Experimental

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.

Label: Online Patient Education

Type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov