DepressionNCT00183417
Depression Prevention Program for Adolescents
A study testing Cognitive behavior therapy (CBT), Supportive/expressive (S/E) therapy and Bibliotherapy in people with Depression, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study will compare the effectiveness of two programs designed to prevent depression in adolescents. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive behavior therapy (CBT), Supportive/expressive (S/E) therapy and Bibliotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to May 2009
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Beck Depression Inventory score higher than 10
- Parent or guardian willing to provide informed consent
Who cannot join
- Diagnosis of depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Depression Prevention Program for High-Risk Adolescents
This study will compare the effectiveness of two programs designed to prevent depression in adolescents.
Read the detailed description
Major depression is one of the most common psychiatric disorders in adolescents. In many cases, the condition is recurrent and can result in serious psychological impairment. A high number of depressed adolescents never receive treatment; therefore, it is crucial to develop prevention programs for this disorder that are effective and can be easily disseminated. This study will evaluate and compare the effectiveness of cognitive behavior therapy (CBT) and supportive/expressive (S/E) therapy in preventing depressive symptoms in adolescents.
This study will last 2 years. Participants will be randomly assigned to receive six sessions of CBT, S/E therapy, or standard depression education over 2 years. The CBT intervention will focus on reducing negative thoughts and increasing engagement in pleasant activities. S/E therapy is designed to allow adolescents to express their negative emotions and talk about recent stressful events in a supportive environment of their peers. Surveys and psychiatric interviews will be completed by all participants and their parents at the beginning and the end of the study. The surveys and interviews will assess depressive symptoms.
- Conditions
- Depression
- Being tested
- Cognitive behavior therapy (CBT), Supportive/expressive (S/E) therapy, Bibliotherapy
- Keywords
- Adolescent, CBT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapy (CBT)Behavioural
Participants will complete worksheets and group discussion on how to increase positive mood and activity.
Supportive/expressive (S/E) therapyBehavioural
Participants will be encouraged to express feelings and emotions without advice giving.
BibliotherapyBehavioural
Participants will be given a book on how to increase their mood.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive cognitive behavioral therapy Receives: Behavioral: Cognitive behavior therapy (CBT) |
| 2 | Active comparator | Participants will receive supportive/expressive therapy Receives: Behavioral: Supportive/expressive (S/E) therapy |
| 3 | Active comparator | Participants will receive bibliotherapy Receives: Behavioral: Bibliotherapy |
| 4 | No intervention | Participants in the control condition will receive no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Eric M. Stice, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183417
- Sponsor's protocol ID
- R01MH067183
- Other IDs
- R01MH067183, DSIR 84-CTP
- Status last verified
- Apr 2012
- First submitted
- 13 Sep 2005
- Last updated
- 25 Apr 2012
- Results posted
- No
Publications
Gau JM, Stice E, Rohde P, Seeley JR. Negative life events and substance use moderate cognitive behavioral adolescent depression prevention intervention. Cogn Behav Ther. 2012;41(3):241-50. doi: 10.1080/16506073.2011.649781. Epub 2012 Mar 13.
PubMed 22414236
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Prevention Program for High-Risk Adolescents
- ClinicalTrials.gov ID
- NCT00183417
- Acronym / sponsor ID
- R01MH067183
- Conditions
- Depression
- Keywords
- Adolescent, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 16 Sep 2005 (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.
This study will compare the effectiveness of two programs designed to prevent depression in adolescents.
Detailed description
Major depression is one of the most common psychiatric disorders in adolescents. In many cases, the condition is recurrent and can result in serious psychological impairment. A high number of depressed adolescents never receive treatment; therefore, it is crucial to develop prevention programs for this disorder that are effective and can be easily disseminated. This study will evaluate and compare the effectiveness of cognitive behavior therapy (CBT) and supportive/expressive (S/E) therapy in preventing depressive symptoms in adolescents.
This study will last 2 years. Participants will be randomly assigned to receive six sessions of CBT, S/E therapy, or standard depression education over 2 years. The CBT intervention will focus on reducing negative thoughts and increasing engagement in pleasant activities. S/E therapy is designed to allow adolescents to express their negative emotions and talk about recent stressful events in a supportive environment of their peers. Surveys and psychiatric interviews will be completed by all participants and their parents at the beginning and the end of the study. The surveys and interviews will assess depressive symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive behavior therapy (CBT)Participants will receive cognitive behavioral therapy |
| 2 | Active comparator | Behavioral: Supportive/expressive (S/E) therapyParticipants will receive supportive/expressive therapy |
| 3 | Active comparator | Behavioral: BibliotherapyParticipants will receive bibliotherapy |
| 4 | No intervention | –Participants in the control condition will receive no treatment |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Beck Depression Inventory score higher than 10
- Parent or guardian willing to provide informed consent
Key exclusion criteria (1 listed)
- Diagnosis of depression
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 behavior therapy (CBT)Participants will complete worksheets and group discussion on how to increase positive mood and activity. | Behavioural | 1 |
| Supportive/expressive (S/E) therapyParticipants will be encouraged to express feelings and emotions without advice giving. | Behavioural | 2 |
| BibliotherapyParticipants will be given a book on how to increase their mood. | Behavioural | 3 |
Primary outcome
Depressive symptoms
Time frame: Measured at Year 1
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 25 Apr 2012.
- Derived from this study: PubMed 22414236Gau JM, Stice E, Rohde P, Seeley JR. Negative life events and substance use moderate cognitive behavioral adolescent depression prevention intervention. Cogn Behav Ther. 2012;41(3):241-50. doi: 10.1080/16506073.2011.649781. Epub 2012 Mar 13.
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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.
Eric M. Stice, PhD principal investigator
University of Texas at Austin
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 behavior therapy (CBT), Supportive/expressive (S/E) therapy and Bibliotherapy in people with Depression, run by University of Texas at Austin 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 2 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 25 Apr 2012. 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?
Depressive symptoms (time frame: Measured at Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00183417, which also lists 1 linked publication.
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 25 Apr 2012; AzTrials last refreshed its copy on 5 Nov 2026.