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Treatment of Depressed Adolescents With Physical Illness
NCT00446238 · View on ClinicalTrials.gov ↗
Study 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. 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.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy
- BEHAVIORAL Standard of Community Care Treatment
Study Locations (2)
Massachusetts
- Children's Hospital Boston — Boston
Pennsylvania
- Children's Hospital of Pittsburgh — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2002-09 |
| Est. Completion | 2007-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00446238
The ClinicalTrials.gov registry entry for NCT00446238 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,082 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions — of which Cognitive Behavioral Therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00446238 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00446238 about?
NCT00446238 is a clinical study titled "Treatment of Depressed Adolescents With Physical Illness". 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 s...
What is the current status of trial NCT00446238?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2002-09. Estimated completion is 2007-08.
What conditions does trial NCT00446238 study?
This clinical trial studies the following conditions: Depression, Inflammatory Bowel Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00446238?
The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), Standard of Community Care Treatment (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00446238?
This trial is sponsored by University of Pittsburgh, which has 1,082 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00446238 being conducted?
This trial has 2 study locations across Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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