NCT00853138

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2 chronic-pain

Timeline
Completed

Started May 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2009

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

February 26, 2009

Last Update Submit

May 26, 2015

Conditions

Chronic PainHeadacheAbdominal Pain

Keywords

cognitive-behavioral therapychronic painrandomized controlled trialpediatrics

Outcome Measures

Primary Outcomes (1)

  • activity limitations

    immediately post-treatment, 3 month follow-up

Secondary Outcomes (3)

  • parental response to pain behaviors

    immediately post-treatment, 3 month follow-up

  • depressive symptoms

    immediately post-treatment, 3 month follow-up

  • pain intensity

    immediately post-treatment, 3 month follow up

Study Arms (2)

CBT

EXPERIMENTAL

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).

Behavioral: cognitive-behavioral therapy

SMC

NO INTERVENTION

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

Interventions

cognitive-behavioral therapyBEHAVIORAL

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.

CBT

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • chronic headache, abdominal, and/or musculoskeletal pain present over the previous 3 months
  • interference from pain in at least one area of daily functioning.

You may not qualify if:

  • serious comorbid chronic condition in the patient (e.g., diabetes, cancer)
  • non-English speaking
  • previous participation in cognitive-behavioral therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 19695776RESULT

  • 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.

    PMID: 22511033RESULT

MeSH Terms

Conditions

Chronic PainHeadacheAbdominal Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tonya M Palermo, PhD

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Anesthesiology and Pain Medicine

Study Record Dates

First Submitted

February 26, 2009

First Posted

March 2, 2009

Study Start

May 1, 2007

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

May 28, 2015

Record last verified: 2015-05