NCT00446238

Brief Summary

The purpose of this study is a randomized trial of cognitive-behavioral intervention (CBI) for eligible adolescents who have Inflammatory Bowel Disease and subsyndromal depressive symptoms, but who did not meet diagnostic criteria for major depressive disorder at the time of randomization into the study. Hypotheses

  1. 1.This preliminary randomized trial will demonstrate the feasibility of a large-scale research initiative.
  2. 2.Subjects will experience no adverse events, and the CBI group will demonstrate improved negative cognitions, depressive symptomatology, and functioning at the post-intervention and 6- through 12-month follow-ups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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, 2002

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

4.9 years

First QC Date

March 8, 2007

Last Update Submit

May 19, 2014

Conditions

Inflammatory Bowel DiseaseDepression

Keywords

DepressionPhysical IllnessInflammatory Bowel DiseaseCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in CDI at 14 weeks

    Change in Childhood Depression Inventory (CDI) scores from week 0 to study endpoint, week 14

    Week 0, Week 14

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

CBT enhanced with physical illness narrative, family education, and social skills components.

Behavioral: Cognitive Behavioral Therapy

Standard of Community Care Treatment

ACTIVE COMPARATOR

Standard of Community Care Treatment

Behavioral: Standard of Community Care Treatment

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

CBT enhanced with physical illness narrative, family education, and social skills components.

Cognitive Behavioral Therapy
Standard of Community Care TreatmentBEHAVIORAL

Treatment as usual for depression and related symptoms provided within the community.

Standard of Community Care Treatment

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Step One
  • Ages 11 to 17 inclusive.
  • Capable of completing CDI
  • English-speaking.
  • Meeting diagnostic criteria for IBD (The date of diagnosis = date of the first diagnostic test confirming IBD)
  • Absence of mental retardation by history
  • Having at least one appointment at the gastroenterology clinic at CHP.
  • Step Two: Assessment
  • \) CDI and/or CDI-P equal to or more than 9 at Step 1
  • At Intervention Phase
  • CDI score equal to or more than 9 AND/OR CDI-P score equal to or more than 9 at T0.
  • Absence of recent suicide attempt (within one month of study enrollment) or depression severity requiring acute psychiatric hospitalization),
  • Age 11-17 years inclusive,
  • Presence of at least one biological parent.

You may not qualify if:

  • Current major depression or dysthymia by Diagnostic and Statistical Manual (DSM)-IV criteria
  • History or current episode of bipolar disorder, eating disorder, or psychotic disorder by DSM-IV criteria.
  • Mental retardation by history
  • Antidepressant or stimulant medications within one month of assessment
  • Suicidality with plan or of severity requiring immediate psychiatric hospitalization or significant act involving intentional self-harm, e.g. cutting or overdose, resulting in medical attention.
  • Unacceptable risk for dangerousness to others as indicated by homicidal (or other violent) ideation, intent or plan or action, or use of illegal weapons.
  • Current pregnancy by history.
  • Substance abuse within one month of enrollment other than nicotine dependence.
  • Current treatment with cognitive behavioral therapy (CBT) or failure of previous CBT trial for depression judged adequate by at least 12 treatment sessions over a period of less than 1 year conducted by an appropriately trained mental health provider.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

  • Szigethy E, Carpenter J, Baum E, Kenney E, Baptista-Neto L, Beardslee WR, Demaso DR. Case study: longitudinal treatment of adolescents with depression and inflammatory bowel disease. J Am Acad Child Adolesc Psychiatry. 2006 Apr;45(4):396-400. doi: 10.1097/01.chi.0000198591.45949.a4.

    PMID: 16601643RESULT

  • Szigethy E, Whitton SW, Levy-Warren A, DeMaso DR, Weisz J, Beardslee WR. Cognitive-behavioral therapy for depression in adolescents with inflammatory bowel disease: a pilot study. J Am Acad Child Adolesc Psychiatry. 2004 Dec;43(12):1469-77. doi: 10.1097/01.chi.0000142284.10574.1f.

    PMID: 15564816RESULT

  • 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

  • Szigethy E, Kenney E, Carpenter J, Hardy DM, Fairclough D, Bousvaros A, Keljo D, Weisz J, Beardslee WR, Noll R, DeMASO DR. Cognitive-behavioral therapy for adolescents with inflammatory bowel disease and subsyndromal depression. J Am Acad Child Adolesc Psychiatry. 2007 Oct;46(10):1290-1298. doi: 10.1097/chi.0b013e3180f6341f.

    PMID: 17885570DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eva Szigethy, MD, PhD

    University of Pittsburgh / Children's Hospital of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • David DeMaso, MD

    Harvard University / Children's Hospital Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry, Pediatrics, and Medicine

Study Record Dates

First Submitted

March 8, 2007

First Posted

March 12, 2007

Study Start

September 1, 2002

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

US(2)