Reducing the Risk of Developing Major Depression in Adolescents/Young Adults With Minor Depression/Depression Symptoms

This study has been terminated.
(Lost funding)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00145951
First received: September 1, 2005
Last updated: March 27, 2014
Last verified: March 2014

September 1, 2005
March 27, 2014
May 2006
September 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00145951 on ClinicalTrials.gov Archive Site
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Reducing the Risk of Developing Major Depression in Adolescents/Young Adults With Minor Depression/Depression Symptoms
Randomized Trial of a Motivational Interview Versus Brief Advice in Primary Care to Engage Mid-Late Adolescents With a Web-based Depression Prevention Intervention

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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample
  • Subjects are between the ages of 14-18 years and
  • have 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
Depression
Behavioral: motivational interviewing, brief advice in primary care
motivational interviewing, brief advice in primary care
  • 1
  • 2
  • 3
    Intervention: Behavioral: motivational interviewing, brief advice in primary care
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
93
December 2011
September 2007   (final data collection date for primary outcome measure)

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).
Both
14 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00145951
13798A
Not Provided
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Benjamin Van Voorhees, MD University of Chicago
University of Chicago
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP