Reducing the Risk of Developing Major Depression in Adolescents/Young Adults With Minor Depression/Depression Symptoms
Recruitment status was Recruiting
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 1, 2005 | ||||
| Last Updated Date | July 17, 2008 | ||||
| Start Date ICMJE | May 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00145951 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Reducing the Risk of Developing Major Depression in Adolescents/Young Adults With Minor Depression/Depression Symptoms | ||||
| Official Title ICMJE | Randomized Trial of a Motivational Interview Versus Brief Advice in Primary Care to Engage Mid-Late Adolescents With a Web-Based Depression Prevention Intervention | ||||
| Brief Summary | The purpose of this research study is to assess the feasibility of a combined primary care/web-based depression prevention intervention. Primary care physicians (PCP) currently lack an alternative behaviorally-based approach to antidepressant medications for individuals with depression symptoms or minor depression, but who have not yet developed Major Depression. The objective of this study is to compare the feasibility and efficacy of motivational interviewing (MI) versus brief advice in primary care to engage adolescents with a web-based depression prevention intervention. |
||||
| Detailed Description | There is no population-based approach to prevent the onset of major depression in adolescence. Adolescents with current sub-threshold depression symptoms (not meeting criteria for major depression, 5 < symptoms including depressed mood, irritability or loss of pleasure), a personal history of a depressive episode in the past or with a family history of depressive disorders are at increased risk. Because most adolescents have regular contact with primary care physicians, the primary care clinics could provide a setting to disseminate evidence-based preventive approaches. We have developed a combined primary care/Web-based preventive intervention to reduce the risk of developing depressive disorders in adolescents and young adults by adapting interventions of demonstrated benefit in study settings to a primary care/Web-based format in collaboration with leading investigators in the field. The goal of this research program is to evaluate the feasibility and possible efficacy of an alternative delivery mechanism for evidence-based behavioral approaches to depression treatment and prevention that have already demonstrated benefit with face-to-face delivery in study settings. Each component this intervention will need to be carefully evaluated for acceptability, safety, feasibility and efficacy. The focus of this study is the primary care component. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population |
|
||||
| Condition ICMJE | Depression | ||||
| Intervention ICMJE | Behavioral: motivational interviewing, brief advice in primary care
motivational interviewing, brief advice in primary care |
||||
| Study Group/Cohort (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 125 | ||||
| Estimated Completion Date | September 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion criteria include:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 14 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00145951 | ||||
| Other Study ID Numbers ICMJE | 13798A | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Dr. Benjamin VanVoorhees, University of Chicago | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Chicago | ||||
| Verification Date | July 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||