Internet Intervention for Adolescents With Chronic Pain

NCT01316471 | Completed Phase 2 DMC

• 1 other identifier: R01HD062538-01A1
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Abdominal Pain; Headache

Keywords

Chronic Pain; Abdominal Pain; Headache; Adolescents; Internet Interventions; Behavioral Interventions

Outcome Measures

Primary Outcomes (2)

• Activity limitations

  Child report of activity limitations will be assessed using the prospective version of the Child Activity Limitations Interview (Palermo, Witherspoon, Valenzuela, \& Drotar, 2004), which includes 8 activities that children identify as important in their day-to-day lives that are impacted by pain. Responses are rated on a 5-point scale (0-4) with higher scores indicating greater perceived difficulty with activities. Children will provide ratings daily for 7 days on their online diaries at each assessment period. Mean activity limitations across the reporting period is used in analyses.

  pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up

• Pain intensity

  Children will report on presence and intensity of pain daily for 7 days at each assessment period. Pain intensity will be assessed using an 11-point numerical rating scale (NRS) with anchors of 0= no pain to 10= worst pain (McGrath et al., 2008). Mean average intensity of the pain reported will serve as primary pain measure.

  pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up

Secondary Outcomes (6)

• 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

Study Arms (2)

Online Behavioral Intervention

EXPERIMENTAL

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.

Behavioral: Online Behavioral Intervention

Online Patient Education

ACTIVE COMPARATOR

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.

Other: Education: Online Patient Education

Interventions

Online Behavioral Intervention BEHAVIORAL

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.

Also known as: Internet Intervention

Online Behavioral Intervention

Education: Online Patient Education OTHER

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.

Also known as: Online Attention Control

Online Patient Education

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• 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.

  PMID: 25775441 RESULT

• 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.

  PMID: 29578090 DERIVED

MeSH Terms

Conditions

Chronic Pain; Abdominal Pain; Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Tonya M. Palermo, Ph.D.

  University of Washington Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 16, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

US (1)