- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06035770
The Effectiveness of Mental Health First Aid Intervention Among Undergraduate Students in Switzerland
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1004
- La Source, School of Nursing Sciences, HES-SO University of Applied Sciences Western Switzerland.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 2nd year undergraduate students from universities of applied science in Lausanne and Yverdon-les-Bains.
- ≥18 years old.
Exclusion Criteria:
- Working and part-time students.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mental Health First Aid 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.
|
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. |
|
No Intervention: control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months; 12 months
|
|
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.
|
3 months; 12 months
|
|
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.
|
3 months; 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mental health-quality of life (changes were assessed assessed at 3 and 12 months)
Time Frame: 3 months; 12 months
|
Quality of life using Short-Form Health Survey (SF-12) and change of quality of life were assessed.
|
3 months; 12 months
|
|
mental health-depression (changes were assessed at 3 and 12 months)
Time Frame: 3 months; 12 months
|
Depression symptoms ( using Patient Health Questionnaire (Brief PHQ-9) and change of depression symptoms were assessed.
|
3 months; 12 months
|
|
change of mental health-anxiety
Time Frame: 3 months; 12 months
|
Anxiety symptom (using Generalized Anxiety Disorder 7) and changes of anxiety symptoms were assessed.
|
3 months; 12 months
|
|
change of mental health-ADHD symptoms
Time Frame: 3 months; 12 months
|
ADHD symptoms were assessed using 'ADHD Self-Report Scale (ASRS)' Screener and the change of ADHD symptoms was also assessed.
|
3 months; 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Meichun Mohler-Kuo, Sc.D., La Source, School of Nursing Sciences, HES-SO
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-01296
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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