Treatment of Depressed Adolescents With Physical Illness
NCT00446238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2014-05-20
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
Interventions
- BEHAVIORAL
-
Cognitive Behavioral Therapy
CBT enhanced with physical illness narrative, family education, and social skills components.
- BEHAVIORAL
-
Standard of Community Care Treatment
Treatment as usual for depression and related symptoms provided within the community.
Sponsors & Collaborators
- collaborator OTHER
- collaborator OTHER
-
National Institutes of Health (NIH)
collaborator NIH -
University of Pittsburgh
lead OTHER
Principal Investigators
-
Eva Szigethy, MD, PhD · University of Pittsburgh / Children's Hospital of Pittsburgh
-
David DeMaso, MD · Harvard University / Children's Hospital Boston
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 11 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-09-30
- Primary Completion
- 2007-08-31
- Completion
- 2007-08-31
Countries
- United States
Study Locations
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