Status:
COMPLETED
Treatment of Depressed Adolescents With Physical Illness
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Harvard University
Boston Children's Hospital
Conditions:
Inflammatory Bowel Disease
Depression
Eligibility:
All Genders
11-17 years
Phase:
NA
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 di...
Detailed Description
This study is a pilot study, which will serve to determine the feasibility of a larger research initiative. The broader research is aimed at the prevention of depressive disorders in adolescents with ...
Eligibility Criteria
Inclusion
- 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
- 1\) 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00446238
Start Date
September 1 2002
End Date
August 1 2007
Last Update
May 20 2014
Active Locations (2)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
2
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213