- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374439
Cognitive Behavioral vs. Interpersonal Therapy (IPT) Prevention of Depression in Adolescents
April 7, 2017 updated by: Judith Garber, Vanderbilt University
Promoting Well-being in Teens
The purpose of this study is to evaluate the efficacy of a cognitive-behavioral vs. an interpersonal therapy program for preventing depressive symptoms in adolescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hypothesis -- The cognitive-behavioral and interpersonal therapy prevention programs will be significantly better than the no-intervention control group in preventing depressive symptoms measured at post-intervention and at the 6-month follow-up.
Gender differences also will be explored.
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203-5721
- Vanderbilt University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All students in 9th grade Wellness classes who have parental consent
Exclusion Criteria:
- Students without parental consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive-behavioral
Participants in this arm received a cognitive-behavioral program
|
Cognitive-behavioral approach
|
Experimental: Interpersonal Therapy
Participants in this arm received a prevention program based on interpersonal therapy for depression
|
Interpersonal therapy approach
|
No Intervention: No intervention
Participants in this arm did not receive an intervention, but complete assessments only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's Depression Inventory
Time Frame: 9 weeks
|
Change in depressive symptoms from baseline to post-intervention at 9 weeks
|
9 weeks
|
Center for Epidemiological Studies - Depression scale
Time Frame: 9 weeks
|
Change in depressive symptoms from baseline to post-intervention at 9 weeks
|
9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2004
Primary Completion (Actual)
January 1, 2006
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
September 8, 2006
First Submitted That Met QC Criteria
September 8, 2006
First Posted (Estimate)
September 11, 2006
Study Record Updates
Last Update Posted (Actual)
April 10, 2017
Last Update Submitted That Met QC Criteria
April 7, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Horowitz Dis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depressive Symptoms
-
Julia EderNot yet recruitingDepressive Disorder | Depression | Depressive Symptoms | Major Depressive Disorder | Depressive EpisodeGermany
-
Medical Research CouncilKU LeuvenCompletedDepressive Symptoms | Major Depressive DisorderAustralia
-
Massachusetts General HospitalCompletedMajor Depressive DisorderUnited States, China
-
Dr. Nazanin AlaviCompletedDepression | Depressive Symptoms | Major Depressive DisorderCanada
-
Linkoeping UniversityCompletedMajor Depressive DisorderSweden
-
The University of Texas Health Science Center at...TerminatedDepression | Major Depressive DisorderUnited States
-
Santa Casa Medical SchoolFaculdade de Ciências Médicas da Santa Casa de São PauloUnknownDepressive SymptomsBrazil
-
State University of New York at BuffaloCompletedDepressive Symptoms | Major Depressive Disorder, Recurrent, in RemissionUnited States
-
University of TorontoKaiser Permanente; University of Colorado, BoulderCompletedDepressive Symptoms | Major Depressive Disorder, Recurrent, in RemissionUnited States
-
University of PittsburghCompleted
Clinical Trials on Cognitive-behavioral
-
Oregon Research InstituteNational Institute of Mental Health (NIMH)CompletedDepressionUnited States
-
UConn HealthCompletedObsessive-Compulsive DisorderUnited States
-
Far Eastern Memorial HospitalUnknownDepression | Inflammation | InsomniaTaiwan
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted