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NCT01128764 · ClinicalTrials.gov registry record · Phase 1
Integrated Treatment for Comorbid Depression and Obesity in Adolescents
A Phase 1 study, sponsored by Brown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01128764 is a Phase 1 study that has completed, run by Brown University. The registered enrollment target is 36 participants.
The verdict
NCT01128764, a Phase 1 study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Lifetime prevalence of major depression is estimated at 28% by age 18 (Lewinsohn et al., 1999), with higher cumulative rates in females (35%) than males (19%). Approximately 17% of children and adolescents in the United States are obese as defined by a BMI above the 95th percentile, with more than 30% falling between the 85th and 95th percentiles (Ogden et al., 2008). Overweight children and adolescents are at increased risk for type 2 diabetes (Pinhas-Hamiel et al., 1996) and overwhelming risk for adult obesity (Guo et al., 1994). There is a substantial percentage of adolescents who are both overweight and depressed with estimates from clinical samples averaging 25%. Treatment of teens with comorbid medical and psychiatric conditions such as overweight/obesity and depression has received little to no attention in the psychosocial treatment research literature. Due to the large number of adolescents who are both depressed and overweight, developing a behavioral treatment that addresses both problems simultaneously has important public health significance. The purpose of this proposal is to combine treatments for depression and overweight to address these co-occurring conditions in one intervention. The long-term objectives of this research are to develop efficient and effective treatments for co-occurring physical and emotional disorders. The research program will be divided into 3 major phases: a development phase (Stage 1a), a pilot study phase (Stage 1b), and a revision phase. During the development phase (Stage 1a), a treatment for overweight teens and CBT treatment for depressed teens will be adapted into one integrated protocol that addresses depression using CBT techniques, an exercise component, and advice regarding healthy eating. As part of this phase, we will adapt existing intervention manuals and therapist training materials, and gain some initial clinical experience with the intervention via an open trial with 6 teens. During the randomized pilot study
Interventions
- BEHAVIORAL CBT for depression and healthy lifestyle plus exercise
- BEHAVIORAL CBT for depression
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01128764
The ClinicalTrials.gov registry entry for NCT01128764 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CBT for depression and healthy lifestyle plus exercise is the first listed.
NCT01128764 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01128764 about?
NCT01128764 is a clinical study titled "Integrated Treatment for Comorbid Depression and Obesity in Adolescents". Lifetime prevalence of major depression is estimated at 28% by age 18 (Lewinsohn et al., 1999), with higher cumulative rates in females (35%) than males (19%). Approximately 17% of children and adolescents in the United States are obese as defined by a BMI above the 95th percentile, with more than 3...
What is the current status of trial NCT01128764?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2009-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01128764?
The interventions under investigation include: CBT for depression and healthy lifestyle plus exercise (BEHAVIORAL), CBT for depression (BEHAVIORAL).
Who is sponsoring clinical trial NCT01128764?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
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