NCT00679003

Brief Summary

Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in significant life disruption, hospitalization and surgery. While psychosocial factors are not believed to cause IBD, such factors can contribute to the ability of individuals with IBD to cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms. The goal of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with IBD. The primary outcomes of interest are IBD symptoms, medical visits, quality of life, and overall disability.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

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

September 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

6.5 years

First QC Date

May 14, 2008

Last Update Submit

April 14, 2015

Conditions

Inflammatory Bowel DiseaseCrohn's DiseaseUlcerative Colitis

Keywords

Crohn's diseaseUlcerative colitisInflammatory bowel diseaseIllness behaviorCognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • Functional Disability Inventory

    Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment

Secondary Outcomes (3)

  • School absences

    Baseline, 3 months, 6 months and 12 months post-treatment

  • Health care utilization for IBD

    Baseline, 3 months, 6 months and 12 months post-treatment

  • Pediatric Quality of Life

    Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment

Study Arms (2)

1

EXPERIMENTAL

Social learning and cognitive behavioral therapy (SLCBT)

Behavioral: SLCBT

2

ACTIVE COMPARATOR

Education and support (ES)

Behavioral: ES

Interventions

SLCBTBEHAVIORAL

Social learning and cognitive behavioral therapy

1
ESBEHAVIORAL

Education and support (information about nutrition and gastrointestinal system)

2

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child has been diagnosed for at least 3 months
  • Child age is 8-17
  • Child has lived with primary caregiver full-time for at least the past 5 years and for at least half of his/ her lifetime
  • Child is medically approved to engage in normal daily activities

You may not qualify if:

  • Chronic disease other than IBD (e.g., pancreatitis, diabetes, epilepsy)
  • Major surgery in past year unrelated to IBD
  • Developmental disabilities that require full-time special education or that impair ability to respond to treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

    PMID: 40243391DERIVED

  • van Tilburg MAL, Claar RL, Romano JM, Langer SL, Drossman DA, Whitehead WE, Abdullah B, Levy RL. Psychological Factors May Play an Important Role in Pediatric Crohn's Disease Symptoms and Disability. J Pediatr. 2017 May;184:94-100.e1. doi: 10.1016/j.jpeds.2017.01.058. Epub 2017 Feb 24.

    PMID: 28238483DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, UlcerativeIllness Behavior

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesBehavior

Study Officials

  • Rona L Levy, MSW, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Tasha B Murphy, PhD

    University of Washington

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 16, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 15, 2015

Record last verified: 2015-04