Depressive SymptomsNCT00374439
Cognitive Behavioral vs. Interpersonal Therapy (IPT) Prevention of Depression in Adolescents
A study testing Cognitive-behavioral and Interpersonal Therapy in people with Depressive Symptoms, run by Vanderbilt University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Cognitive-behavioral and Interpersonal Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All students in 9th grade Wellness classes who have parental consent
Who cannot join
- Students without parental consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University
Nashville, Tennessee, 37203-5721
About this study
Official title: 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.
Read the 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.
- Conditions
- Depressive Symptoms
- Being tested
- Cognitive-behavioral, Interpersonal Therapy
- Keywords
- depression, adolescents, prevention, schools
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioralBehavioural
Cognitive-behavioral approach
Interpersonal TherapyBehavioural
Interpersonal therapy approach
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral | Experimental | Participants in this arm received a cognitive-behavioral program Receives: Behavioral: Cognitive-behavioral |
| Interpersonal Therapy | Experimental | Participants in this arm received a prevention program based on interpersonal therapy for depression Receives: Behavioral: Interpersonal Therapy |
| No intervention | No intervention | Participants in this arm did not receive an intervention, but complete assessments only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Depression Inventory
Change in depressive symptoms from baseline to post-intervention at 9 weeks
Measured: 9 weeks
Center for Epidemiological Studies - Depression scale
Change in depressive symptoms from baseline to post-intervention at 9 weeks
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startJan 2004
- Primary completionJan 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Garber, Vanderbilt University Medical Center
- Investigators
- Judy Garber, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374439
- Sponsor's protocol ID
- Horowitz Dis
- Status last verified
- Apr 2017
- First submitted
- 8 Sep 2006
- Last updated
- 10 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Well-being in Teens
- ClinicalTrials.gov ID
- NCT00374439
- Acronym / sponsor ID
- Horowitz Dis
- Conditions
- Depressive Symptoms
- Keywords
- depression, adolescents, prevention, schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2004 (actual)
- Primary completion
- Jan 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral | Experimental | Behavioral: Cognitive-behavioralParticipants in this arm received a cognitive-behavioral program |
| Interpersonal Therapy | Experimental | Behavioral: Interpersonal TherapyParticipants in this arm received a prevention program based on interpersonal therapy for depression |
| No intervention | No intervention | –Participants in this arm did not receive an intervention, but complete assessments only |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All students in 9th grade Wellness classes who have parental consent
Key exclusion criteria (1 listed)
- Students without parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioralCognitive-behavioral approach | Behavioural | Cognitive-behavioral |
| Interpersonal TherapyInterpersonal therapy approach | Behavioural | Interpersonal Therapy |
Primary outcome
Children's Depression Inventory
Time frame: 9 weeks
Change in depressive symptoms from baseline to post-intervention at 9 weeks
Center for Epidemiological Studies - Depression scale
Time frame: 9 weeks
Change in depressive symptoms from baseline to post-intervention at 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Garber, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral and Interpersonal Therapy in people with Depressive Symptoms, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Depression Inventory (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.