Clinical Trial: A Combined Primary Care/Web-Based Preventive Intervention to Reduce the Risk of Developing Major Depression in Adolescents and Young Adults with Minor Depression or Depression Symptoms.

This study is not yet open for patient recruitment.
Verified by University of Chicago September 2005

Sponsored by: University of Chicago
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00145951

Purpose

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.

Condition Intervention
Depression
 Behavior: motivational interviewing, brief advice in primary care

MedlinePlus related topics:  Depression

Study Type: Observational
Study Design: Psychosocial, Longitudinal, Case Control, Prospective Study

Official Title: Randomized Trial of a Motivational Interview Versus Brief Advice in Primary Care to Engage Mid-Late Adolescents with a Web-Based Depression Prevention Intervention

Further Study Details: 

Expected Total Enrollment:  125

Study start: September 2005;  Expected completion: September 2007
Last follow-up: September 2007;  Data entry closure: September 2007

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.

Eligibility

Ages Eligible for Study:  14 Years   -   75 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Inclusion criteria include: (1) age 14-18 years and (2) one risk factor for developing depression in the next two years: sub-clinical depressed mood (not meeting criteria of major depression), a family history of depression in a parent or sibling, or past personal history of depression or personal perception of risk depression and desire to participate

Exclusion Criteria:

  • criteria include meeting criteria or undergoing active treatment for major depression (5 or more symptoms nearly every day with functional impairment, minor depression), bipolar disorder, panic disorder, conduct disorder, substance abuse or having suicidal ideation. Active treatment for depression is defined as receiving anti-depressant medication or counseling within one year of remission of symptoms from the most recent episode. Those who meet DSM-IV criteria for minor depression (3-4 symptoms) or who report significant functional impairment (very difficult or above on the Prime MD functional impairment scale) will be notified and offered a referral for an evaluation by a mental health specialist (and will be strongly encouraged to attend). Those with 1-2 symptoms of depression will also be offered evaluation and treatment from a mental health specialist. In each case, the primary care physician will be notified and the parents (if under the age of 19).

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00145951

Benjamin Van Voorhees, MD      (773) 702-3835    bvanvoor@medicine.bsd.uchicago.edu

Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States
Benjamin Van Voorhees, MD  773-702-3835    bvanvoor@medicine.bsd.uchicago.edu 
Benjamin Van Voorhees, MD,  Principal Investigator

Study chairs or principal investigators

Benjamin Van Voorhees, MD,  Principal Investigator,  University of Chicago   

More Information

Study ID Numbers:  13798A
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145951
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06



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