Clinical trial NCT01316471: Internet Intervention for Adolescents With Chronic Pain
Official title: Web-MAP 2: Internet Intervention for Adolescents With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pain
Abdominal Pain
Headache
Keywords: Chronic Pain
Abdominal Pain
Headache
Adolescents
Internet Interventions
Behavioral Interventions
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 273
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Activity limitations
timeFrame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
measure: Pain intensity
timeFrame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Secondary outcomes:
measure: Depression and pain-specific anxiety
timeFrame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
measure: Treatment Satisfaction
timeFrame: Immediately Post-Treatment, 6-month follow-up, 12-month follow-up
measure: Parental Response to Pain Behavior
timeFrame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
measure: Sleep Quality
timeFrame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
measure: Health service Use
timeFrame: pre-treatment, 12-month follow-up
measure: Miscarried Helping
timeFrame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Washington Medical School
name: Tonya M. Palermo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palermo TM, Law EF, Zhou C, Holley AL, Logan D, Tai G. Trajectories of change during a randomized controlled trial of internet-delivered psychological treatment for adolescent chronic pain: how does change in pain and function relate? Pain. 2015 Apr;156(4):626-634. doi: 10.1097/01.j.pain.0000460355.17246.6c.
citation: Law EF, Groenewald CB, Zhou C, Palermo TM. Effect on Health Care Costs for Adolescents Receiving Adjunctive Internet-Delivered Cognitive-Behavioral Therapy: Results of a Randomized Controlled Trial. J Pain. 2018 Aug;19(8):910-919. doi: 10.1016/j.jpain.2018.03.004. Epub 2018 Mar 22.