Preventative MedicineNCT06035770
The Effectiveness of Mental Health First Aid Intervention Among Undergraduate Students in Switzerland
A study testing Mental Health First Aid (educational training program) in people with Preventative Medicine, run by Institut et Haute Ecole de la Santé la Source at 1 site in Switzerland.
Trial summary
Mental Health First Aid (MHFA) is an educational training program which has been proven effective at increasing knowledge, improving attitudes and reducing the stigma of mental illness among individuals/the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preventative Medicine
- What is being tested?
- Mental Health First Aid (educational training program)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Sep 2019to 31 Dec 2020
- 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
- 2nd year undergraduate students from universities of applied science in Lausanne and Yverdon-les-Bains.
- ≥18 years old.
Who cannot join
- Working and part-time students.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
La Source, School of Nursing Sciences, HES-SO University of Applied Sciences Western Switzerland.
Lausanne, Canton of Vaud, 1004
About this study
Official title: The Effectiveness of Ensa - Mental Health First Aid Training on Knowledge and Mental Health of Undergraduate Students in Switzerland: a Randomised Control Trial.
Mental Health First Aid (MHFA) is an educational training program which has been proven effective at increasing knowledge, improving attitudes and reducing the stigma of mental illness among individuals/the general population. Although MHFA has proven effective world-wide, no study has examined the effectiveness of MHFA in Switzerland and very few studies have examined the long-term effects of MHFA and how they might be influenced by cultural differences. This study is a randomized control trial (RCT) that examines the effectiveness of a 12-hour MHFA training program that aims to improve undergraduate students' knowledge of, behaviours towards mental illness and to reduce stigmatization towards mental illness. All participants were 2nd-year students and they were randomly assigned either to an intervention group that would receive the MHFA training course or to a control group without any intervention during the study period. However, the control group had the option to receive the MHFA course after the 12 months of study follow-up was completed. Both groups were assessed at three time points: T0: Baseline survey from mid-September to October 2019, completed by both groups.
Intervention: MHFA training program from October 2019-December 2019. T1: Post-intervention with first follow-up survey three months after the MHFA training intervention completed by both groups (from March to May 2020). T2: Follow-up 12 months after the MHFA/ensa training intervention in December 2020 and completed by both groups.
- Conditions
- Preventative Medicine
- Being tested
- Mental Health First Aid (educational training program)
- Keywords
- mental health first aid;, undergraduate students;, RCT, intervention, education program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health First Aid (educational training program)Other
The MHFA program is a 12-hour face-to-face training program delivered in four sessions of three hours each across four consecutive weeks by two accredited MHFA instructors. The class was administered in small groups with a maximum of 10-15 students.The program included didactic lectures and "role playing" to teach students how to recognize and react to the signs and symptoms of mental health illness. Participants enrolled in the intervention group received an accompanying manual with content that covered helping people in mental health crises and/or the early stages of mental health problems.
The mental health problems addressed during the training session included depressive symptoms, anxiety, psychotic disorders, and substance use disorders. The mental health crisis situations included suicidal thoughts/attempts and behaviors, acute stress reactions,panic attacks, and acute psychotic behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Mental Health First Aid training program | Experimental | The intervention is a 12-hour face-to-face training course given in small groups. It was delivered as four 3-hour sessions over 4 consecutive weeks. Receives: Other: Mental Health First Aid (educational training program) |
| control group | No intervention | The control group received no intervention during the intervention period. However, they will participate in surveys at three time points (before the intervention, 3 months after the intervention and one year after the intervention). Once their final assessment is completed, controls will be offered the opportunity to take the MHFA training course, if they wish. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of knowledge-(changes were assessed at 3 and 12 months)
to measure participants' ability to identify a mental health problem and answer questions based on the content of the MHFA course. Changes of knowledge level before and after the MHFA intervention are also assessed.
Measured: 3 months; 12 months
Level of attitudes pertaining to mental illness (changes were assessed at 3 and 12 months)
to measure changes of participants' level of stigmatization and social distance toward mental illness. Changes of before and after the intervention are also assessed.
Measured: 3 months; 12 months
behaviors toward mental illness (changes are assessed at 3 and 12 months))
to measure participants' confidence and intention to provide help and the changes before and after the MHFA are also assessed.
Measured: 3 months; 12 months
Secondary outcomes (4)
mental health-quality of life (changes were assessed assessed at 3 and 12 months)
Quality of life using Short-Form Health Survey (SF-12) and change of quality of life were assessed.
Measured: 3 months; 12 months
mental health-depression (changes were assessed at 3 and 12 months)
Depression symptoms ( using Patient Health Questionnaire (Brief PHQ-9) and change of depression symptoms were assessed.
Measured: 3 months; 12 months
change of mental health-anxiety
Anxiety symptom (using Generalized Anxiety Disorder 7) and changes of anxiety symptoms were assessed.
Measured: 3 months; 12 months
change of mental health-ADHD symptoms
ADHD symptoms were assessed using 'ADHD Self-Report Scale (ASRS)' Screener and the change of ADHD symptoms was also assessed.
Measured: 3 months; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start20 Sep 2019
- Primary completion1 Mar 2020
- Study completion31 Dec 2020
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 Preventative MedicineStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control trial with educational intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut et Haute Ecole de la Santé la Source
- Sponsor type
- University, hospital or other
- Collaborators
- HEIG-VD- Haute Ecole d'Ingénierie et de Gestion du Canton de Vaud
- Responsible party
- Principal investigator, Meichun Mohler-Kuo, Sc.D, Institut et Haute Ecole de la Santé la Source
- Investigators
- Meichun Mohler-Kuo, Sc.D., Principal investigator, La Source, School of Nursing Sciences, HES-SO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035770
- Sponsor's protocol ID
- 2019-01296
- Other IDs
- 2019
- Status last verified
- Sep 2023
- First submitted
- 23 Jun 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dzemaili S, Pasquier J, Oulevey Bachmann A, Mohler-Kuo M. The Effectiveness of Mental Health First Aid Training among Undergraduate Students in Switzerland: A Randomized Control Trial. Int J Environ Res Public Health. 2023 Jan 11;20(2):1303. doi: 10.3390/ijerph20021303.
PubMed 36674060
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Ensa - Mental Health First Aid Training on Knowledge and Mental Health of Undergraduate Students in Switzerland: a Randomised Control Trial.
- ClinicalTrials.gov ID
- NCT06035770
- Acronym / sponsor ID
- 2019-01296
- Conditions
- Preventative Medicine
- Keywords
- mental health first aid;, undergraduate students;, RCT, intervention, education program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Institut et Haute Ecole de la Santé la SourceUniversity, hospital or other
- Collaborators
- HEIG-VD- Haute Ecole d'Ingénierie et de Gestion du Canton de Vaud
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Sep 2023 (actual)
- 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.
Mental Health First Aid (MHFA) is an educational training program which has been proven effective at increasing knowledge, improving attitudes and reducing the stigma of mental illness among individuals/the general population. Although MHFA has proven effective world-wide, no study has examined the effectiveness of MHFA in Switzerland and very few studies have examined the long-term effects of MHFA and how they might be influenced by cultural differences. This study is a randomized control trial (RCT) that examines the effectiveness of a 12-hour MHFA training program that aims to improve undergraduate students' knowledge of, behaviours towards mental illness and to reduce stigmatization towards mental illness. All participants were 2nd-year students and they were randomly assigned either to an intervention group that would receive the MHFA training course or to a control group without any intervention during the study period. However, the control group had the option to receive the MHFA course after the 12 months of study follow-up was completed. Both groups were assessed at three time points: T0: Baseline survey from mid-September to October 2019, completed by both groups.
Intervention: MHFA training program from October 2019-December 2019. T1: Post-intervention with first follow-up survey three months after the MHFA training intervention completed by both groups (from March to May 2020). T2: Follow-up 12 months after the MHFA/ensa training intervention in December 2020 and completed by both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control trial with educational intervention
| Arm | Type | Receives |
|---|---|---|
| Mental Health First Aid training program | Experimental | Other: Mental Health First Aid (educational training program)The intervention is a 12-hour face-to-face training course given in small groups. It was delivered as four 3-hour sessions over 4 consecutive weeks. |
| control group | No intervention | –The control group received no intervention during the intervention period. However, they will participate in surveys at three time points (before the intervention, 3 months after the intervention and one year after the intervention). Once their final assessment is completed, controls will be offered the opportunity to take the MHFA training course, if they wish. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 2nd year undergraduate students from universities of applied science in Lausanne and Yverdon-les-Bains.
- ≥18 years old.
Key exclusion criteria (1 listed)
- Working and part-time students.
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 Aid (educational training program)The MHFA program is a 12-hour face-to-face training program delivered in four sessions of three hours each across four consecutive weeks by two accredited MHFA instructors. The class was administered in small groups with a maximum of 10-15 students.The program included didactic lectures and "role playing" to teach students how to recognize and react to the signs and symptoms of mental health illness. Participants enrolled in the intervention group received an accompanying manual with content that covered helping people in mental health crises and/or the early stages of mental health problems. The mental health problems addressed during the training session included depressive symptoms, anxiety, psychotic disorders, and substance use disorders. The mental health crisis situations included suicidal thoughts/attempts and behaviors, acute stress reactions,panic attacks, and acute psychotic behaviors. | Other | Mental Health First Aid training program |
Primary outcome
Level of knowledge-(changes were assessed at 3 and 12 months)
Time frame: 3 months; 12 months
to measure participants' ability to identify a mental health problem and answer questions based on the content of the MHFA course. Changes of knowledge level before and after the MHFA intervention are also assessed.
Level of attitudes pertaining to mental illness (changes were assessed at 3 and 12 months)
Time frame: 3 months; 12 months
to measure changes of participants' level of stigmatization and social distance toward mental illness. Changes of before and after the intervention are also assessed.
behaviors toward mental illness (changes are assessed at 3 and 12 months))
Time frame: 3 months; 12 months
to measure participants' confidence and intention to provide help and the changes before and after the MHFA are also assessed.
4 secondary outcomes
mental health-quality of life (changes were assessed assessed at 3 and 12 months)
Time frame: 3 months; 12 months
mental health-depression (changes were assessed at 3 and 12 months)
Time frame: 3 months; 12 months
change of mental health-anxiety
Time frame: 3 months; 12 months
change of mental health-ADHD symptoms
Time frame: 3 months; 12 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 13 Sep 2023.
- Results publication: PubMed 36674060Dzemaili S, Pasquier J, Oulevey Bachmann A, Mohler-Kuo M. The Effectiveness of Mental Health First Aid Training among Undergraduate Students in Switzerland: A Randomized Control Trial. Int J Environ Res Public Health. 2023 Jan 11;20(2):1303. doi: 10.3390/ijerph20021303.
- Individual participant dataSharing planned: No
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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.
Meichun Mohler-Kuo, Sc.D. principal investigator
La Source, School of Nursing Sciences, HES-SO
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 (educational training program) in people with Preventative Medicine, run by Institut et Haute Ecole de la Santé la Source at 1 site in Switzerland.
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 2 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 13 Sep 2023. 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 Switzerland. 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?
Level of knowledge-(changes were assessed at 3 and 12 months) (time frame: 3 months; 12 months). The study lists 3 primary outcomes in all. 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 NCT06035770, 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 13 Sep 2023.