Clinical trial NCT00145951: Reducing the Risk of Developing Major Depression in Adolescents/Young Adults With Minor Depression/Depression Symptoms
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Depression
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 93
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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

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.

Eligibility 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Benjamin Van Voorhees, MD
role: PRINCIPAL_INVESTIGATOR
References: