Treatment of Depressed Adolescents With Physical Illness

Completed · Not applicable

Conditions studied: Inflammatory Bowel Disease, Depression

In brief

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. This preliminary randomized trial will demonstrate the feasibility of a large-scale research initiative. 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.

Key facts

Study ID

NCT00446238

Run by

University of Pittsburgh

People needed

41

Starts

2002-09-01

Expected to finish

2007-08-01

Last updated by the study team

2014-05-20

Who can join

Age: 11 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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