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

Sponsor
University of Chicago (Other)
Overall Status
Terminated
CT.gov ID
NCT00145951
Collaborator
(none)
93
1
67
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: motivational interviewing, brief advice in primary care

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 Design

Study Type:
Observational
Actual Enrollment :
93 participants
Time Perspective:
Prospective
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
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
1

2

3

Behavioral: motivational interviewing, brief advice in primary care
motivational interviewing, brief advice in primary care

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT00145951
    Other Study ID Numbers:
    • 13798A
    First Posted:
    Sep 5, 2005
    Last Update Posted:
    Mar 28, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 28, 2014