DepressionNCT02021344
Mental Health First Aid for College Students
A study testing Mental Health First Aid in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.
Trial summary
Most college students with mental disorders do not receive treatment, and over 80% of those who die by suicide have never made contact with campus mental health services. Knowledge, stigma, and other health beliefs represent significant barriers to help-seeking for many of these students. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Suicidal Ideation
- What is being tested?
- Mental Health First Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,543 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Student enrolled in a participating campus as a full-time, residential undergraduate during the 2009-2010 or 2010-2011 academic years. Student must have been living in a participating residence hall.
Who cannot join
- Students under 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health First Aid for College Students: A Multi-campus Randomized Control Trial of a Community Health Intervention
Most college students with mental disorders do not receive treatment, and over 80% of those who die by suicide have never made contact with campus mental health services. Knowledge, stigma, and other health beliefs represent significant barriers to help-seeking for many of these students. However, there have been no large-scale intervention studies for reducing these barriers to mental health treatment on college campuses. This project will fill this gap by determining whether a community mental health education program, Mental Health First Aid (MHFA), is an effective method to increase number of students who seek mental health services on college campuses. MHFA is an international, 12-hour training program that has been shown to increase knowledge of mental illnesses and their treatments, decrease stigma, and increase helping behaviors in community members. However, it has not been tested in a college setting in the United States. To determine the effectiveness of MHFA in US colleges, the proposed project will involve a randomized control trial of the MHFA training program on 32 campuses representing a range of higher education institutions, from community colleges in rural areas to research universities in large, urban areas. The MHFA training program will be administered to peer supports such as residential advisors. Administrative data from campus mental health services and pre- and post-intervention surveys will be used to collect outcome data on service utilization, knowledge, attitudes, and other measures. Data analyses will focus on identifying changes in students' behaviors, knowledge, and attitudes toward mental illnesses that can be attributed to the MHFA training. In addition to testing a novel and timely mental health intervention for college students, this project will result in improved data collection measures for college populations, and will lay the foundation for stronger connections and future collaborations between diverse campus communities. If the MHFA program is successful in reducing stigma and increasing general on-campus awareness and early treatment of emerging mental health problems, then it may provide a cost-effective means for enabling more students to seek early treatments for developing mental health problems.
- Conditions
- Depression, Anxiety, Suicidal Ideation, Eating Disorders
- Being tested
- Mental Health First Aid
- Medical subject headings
- Depression, Anxiety Disorders, Suicidal Ideation, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health First AidBehavioural
Originally developed in 2001, MHFA is a 12-hour course comprised of six modules, covering depression, anxiety, psychosis, substance abuse, eating disorders, and self-harm. Each module includes information about the mental health-related problems (e.g., signs and symptoms), advice on how to respond appropriately, and interactive activities to enhance the learning process. Some modules include videos with perspectives of individuals recovering from mental disorders and examples of how to effectively use the MHFA intervention. Program participants learn how to help individuals in crisis and also how to recognize early warning signs and intervene before mental health problems progress to crises.
| Study group | Role | What they receive |
|---|---|---|
| Pure control | No intervention | Practice as usual (no MHFA) in all residences on these campuses. |
| Intervention residence on mixed campus | Experimental | Mental Health First Aid delivered to these residences, but not all other residences at the same campus. Receives: Behavioral: Mental Health First Aid |
| Pure intervention residence | Experimental | Mental Health First Aid delivered to this residence and all other residences at the same campus Receives: Behavioral: Mental Health First Aid |
| Control at mixed campus | No intervention | Practice as usual (no MHFA) at this residence, but some other residences at same campus are in experimental condition (MHFA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mental health service utilization
Measured: baseline, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,543 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Daniel Eisenberg, University of Michigan
- Investigators
- Daniel Eisenberg, PhD, Principal investigator, University of MichiganNicole L Speer, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021344
- Sponsor's protocol ID
- NIMH 1RC1MH089757-01
- Other IDs
- 1RC1MH089757-01
- Status last verified
- Dec 2013
- First submitted
- 14 Dec 2013
- Last updated
- 27 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Richardson R, Dale HE, Robertson L, Meader N, Wellby G, McMillan D, Churchill R. Mental Health First Aid as a tool for improving mental health and well-being. Cochrane Database Syst Rev. 2023 Aug 22;8(8):CD013127. doi: 10.1002/14651858.CD013127.pub2.
PubMed 37606172
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health First Aid for College Students: A Multi-campus Randomized Control Trial of a Community Health Intervention
- ClinicalTrials.gov ID
- NCT02021344
- Acronym / sponsor ID
- NIMH 1RC1MH089757-01
- Conditions
- Depression, Anxiety, Suicidal Ideation, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,543 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Dec 2013 (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.
Most college students with mental disorders do not receive treatment, and over 80% of those who die by suicide have never made contact with campus mental health services. Knowledge, stigma, and other health beliefs represent significant barriers to help-seeking for many of these students. However, there have been no large-scale intervention studies for reducing these barriers to mental health treatment on college campuses. This project will fill this gap by determining whether a community mental health education program, Mental Health First Aid (MHFA), is an effective method to increase number of students who seek mental health services on college campuses. MHFA is an international, 12-hour training program that has been shown to increase knowledge of mental illnesses and their treatments, decrease stigma, and increase helping behaviors in community members. However, it has not been tested in a college setting in the United States. To determine the effectiveness of MHFA in US colleges, the proposed project will involve a randomized control trial of the MHFA training program on 32 campuses representing a range of higher education institutions, from community colleges in rural areas to research universities in large, urban areas. The MHFA training program will be administered to peer supports such as residential advisors. Administrative data from campus mental health services and pre- and post-intervention surveys will be used to collect outcome data on service utilization, knowledge, attitudes, and other measures. Data analyses will focus on identifying changes in students' behaviors, knowledge, and attitudes toward mental illnesses that can be attributed to the MHFA training. In addition to testing a novel and timely mental health intervention for college students, this project will result in improved data collection measures for college populations, and will lay the foundation for stronger connections and future collaborations between diverse campus communities. If the MHFA program is successful in reducing stigma and increasing general on-campus awareness and early treatment of emerging mental health problems, then it may provide a cost-effective means for enabling more students to seek early treatments for developing mental health problems.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pure control | No intervention | –Practice as usual (no MHFA) in all residences on these campuses. |
| Intervention residence on mixed campus | Experimental | Behavioral: Mental Health First AidMental Health First Aid delivered to these residences, but not all other residences at the same campus. |
| Pure intervention residence | Experimental | Behavioral: Mental Health First AidMental Health First Aid delivered to this residence and all other residences at the same campus |
| Control at mixed campus | No intervention | –Practice as usual (no MHFA) at this residence, but some other residences at same campus are in experimental condition (MHFA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Student enrolled in a participating campus as a full-time, residential undergraduate during the 2009-2010 or 2010-2011 academic years. Student must have been living in a participating residence hall.
Key exclusion criteria (1 listed)
- Students under 18 years of age.
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 |
|---|---|---|
| Mental Health First AidOriginally developed in 2001, MHFA is a 12-hour course comprised of six modules, covering depression, anxiety, psychosis, substance abuse, eating disorders, and self-harm. Each module includes information about the mental health-related problems (e.g., signs and symptoms), advice on how to respond appropriately, and interactive activities to enhance the learning process. Some modules include videos with perspectives of individuals recovering from mental disorders and examples of how to effectively use the MHFA intervention. Program participants learn how to help individuals in crisis and also how to recognize early warning signs and intervene before mental health problems progress to crises. | Behavioural | Intervention residence on mixed campus, Pure intervention residence |
Primary outcome
Changes in mental health service utilization
Time frame: baseline, 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2013.
- Derived from this study: PubMed 37606172Richardson R, Dale HE, Robertson L, Meader N, Wellby G, McMillan D, Churchill R. Mental Health First Aid as a tool for improving mental health and well-being. Cochrane Database Syst Rev. 2023 Aug 22;8(8):CD013127. doi: 10.1002/14651858.CD013127.pub2.
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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.
Daniel Eisenberg, PhD principal investigator
University of Michigan
Nicole L Speer, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health First Aid in people with Depression and Anxiety, run by University of Michigan 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Dec 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Changes in mental health service utilization (time frame: baseline, 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02021344, which also lists 1 linked publication.
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 27 Dec 2013.