DepressionNCT00145951
Reducing the Risk of Developing Major Depression in Adolescents/Young Adults With Minor Depression/Depression Symptoms
An observational study of Depression, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- motivational interviewing, brief advice in primary care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- (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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Depression
- Being tested
- motivational interviewing, brief advice in primary care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewing, brief advice in primary careBehavioural
motivational interviewing, brief advice in primary care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described | |
| 3 | Not described Receives: Behavioral: motivational interviewing, brief advice in primary care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startMay 2006
- Primary completionSep 2007
- Study completionDec 2011
Why it stopped: Lost funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Van Voorhees, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145951
- Sponsor's protocol ID
- 13798A
- Status last verified
- Mar 2014
- First submitted
- 1 Sep 2005
- Last updated
- 28 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00145951
- Acronym / sponsor ID
- 13798A
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lost funding
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
| 3 | – | Behavioral: motivational interviewing, brief advice in primary care |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- (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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motivational interviewing, brief advice in primary caremotivational interviewing, brief advice in primary care | Behavioural | 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lost funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Van Voorhees, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lost funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014.