NCT06035770

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

June 23, 2023

Last Update Submit

September 6, 2023

Conditions

Keywords

mental health first aid;undergraduate students;RCTinterventioneducation program

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    3 months; 12 months

Secondary Outcomes (4)

  • mental health-quality of life (changes were assessed assessed at 3 and 12 months)

    3 months; 12 months

  • mental health-depression (changes were assessed at 3 and 12 months)

    3 months; 12 months

  • change of mental health-anxiety

    3 months; 12 months

  • change of mental health-ADHD symptoms

    3 months; 12 months

Study Arms (2)

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.

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.

Interventions

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.

Mental Health First Aid training program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nd year undergraduate students from universities of applied science in Lausanne and Yverdon-les-Bains.
  • ≥18 years old.

You may not qualify if:

  • Working and part-time students.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Source, School of Nursing Sciences, HES-SO University of Applied Sciences Western Switzerland.

Lausanne, Canton of Vaud, 1004, Switzerland

Location

Related Publications (1)

  • 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.

Study Officials

  • Meichun Mohler-Kuo, Sc.D.

    La Source, School of Nursing Sciences, HES-SO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Control trial with educational intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sc.D. Professeur Ordinaire HES-SO

Study Record Dates

First Submitted

June 23, 2023

First Posted

September 13, 2023

Study Start

September 20, 2019

Primary Completion

March 1, 2020

Study Completion

December 31, 2020

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations