NCT00145951

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

September 1, 2005

Last Update Submit

March 27, 2014

Conditions

Study Arms (3)

1

2

3

Behavioral: motivational interviewing, brief advice in primary care

Interventions

motivational interviewing, brief advice in primary care

3

Eligibility Criteria

Age14 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • (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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Motivational InterviewingCrisis InterventionPrimary Health Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesPsychotherapyComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Benjamin Van Voorhees, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

May 1, 2006

Primary Completion

September 1, 2007

Study Completion

December 1, 2011

Last Updated

March 28, 2014

Record last verified: 2014-03

Locations