xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06035770</url>
    </required_header>
    <id_info>
      <org_study_id>2019-01296</org_study_id>
      <nct_id>NCT06035770</nct_id>
    </id_info>
    <brief_title>The Effectiveness of Mental Health First Aid Intervention Among Undergraduate Students in Switzerland</brief_title>
    <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.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut et Haute Ecole de la Santé la Source</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>HEIG-VD- Haute Ecole d'Ingénierie et de Gestion du Canton de Vaud</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Institut et Haute Ecole de la Santé la Source</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Mental Health First Aid (MHFA) is an educational training program which has been proven&#xD;
        effective at increasing knowledge, improving attitudes and reducing the stigma of mental&#xD;
        illness among individuals/the general population. Although MHFA has proven effective&#xD;
        world-wide, no study has examined the effectiveness of MHFA in Switzerland and very few&#xD;
        studies have examined the long-term effects of MHFA and how they might be influenced by&#xD;
        cultural differences. This study is a randomized control trial (RCT) that examines the&#xD;
        effectiveness of a 12-hour MHFA training program that aims to improve undergraduate students'&#xD;
        knowledge of, behaviours towards mental illness and to reduce stigmatization towards mental&#xD;
        illness. All participants were 2nd-year students and they were randomly assigned either to an&#xD;
        intervention group that would receive the MHFA training course or to a control group without&#xD;
        any intervention during the study period. However, the control group had the option to&#xD;
        receive the MHFA course after the 12 months of study follow-up was completed. Both groups&#xD;
        were assessed at three time points: T0: Baseline survey from mid-September to October 2019,&#xD;
        completed by both groups.&#xD;
  &#xD;
        Intervention: MHFA training program from October 2019-December 2019. T1: Post-intervention&#xD;
        with first follow-up survey three months after the MHFA training intervention completed by&#xD;
        both groups (from March to May 2020). T2: Follow-up 12 months after the MHFA/ensa training&#xD;
        intervention in December 2020 and completed by both groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 20, 2019</start_date>
    <completion_date type="Actual">December 31, 2020</completion_date>
    <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized Control trial with educational intervention</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Level of knowledge-(changes were assessed at 3 and 12 months)</measure>
      <time_frame>3 months; 12 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Level of attitudes pertaining to mental illness (changes were assessed at 3 and 12 months)</measure>
      <time_frame>3 months; 12 months</time_frame>
      <description>to measure changes of participants' level of stigmatization and social distance toward mental illness. Changes of before and after the intervention are also assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>behaviors toward mental illness (changes are assessed at 3 and 12 months))</measure>
      <time_frame>3 months; 12 months</time_frame>
      <description>to measure participants' confidence and intention to provide help and the changes before and after the MHFA are also assessed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>mental health-quality of life (changes were assessed assessed at 3 and 12 months)</measure>
      <time_frame>3 months; 12 months</time_frame>
      <description>Quality of life using Short-Form Health Survey (SF-12) and change of quality of life were assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mental health-depression (changes were assessed at 3 and 12 months)</measure>
      <time_frame>3 months; 12 months</time_frame>
      <description>Depression symptoms ( using Patient Health Questionnaire (Brief PHQ-9) and change of depression symptoms were assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of mental health-anxiety</measure>
      <time_frame>3 months; 12 months</time_frame>
      <description>Anxiety symptom (using Generalized Anxiety Disorder 7) and changes of anxiety symptoms were assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of mental health-ADHD symptoms</measure>
      <time_frame>3 months; 12 months</time_frame>
      <description>ADHD symptoms were assessed using 'ADHD Self-Report Scale (ASRS)' Screener and the change of ADHD symptoms was also assessed.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">107</enrollment>
    <condition>Preventative Medicine</condition>
    <arm_group>
      <arm_group_label>Mental Health First Aid training program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mental Health First Aid (educational training program)</intervention_name>
      <description>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 &quot;role playing&quot; 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.&#xD;
  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.</description>
      <arm_group_label>Mental Health First Aid training program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  2nd year undergraduate students from universities of applied science in Lausanne and&#xD;
               Yverdon-les-Bains.&#xD;
  &#xD;
            -  ≥18 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Working and part-time students.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Meichun Mohler-Kuo, Sc.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>La Source, School of Nursing Sciences, HES-SO</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>La Source, School of Nursing Sciences, HES-SO University of Applied Sciences Western Switzerland.</name>
        <address>
          <city>Lausanne</city>
          <state>Vaud</state>
          <zip>1004</zip>
          <country>Switzerland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <results_reference>
      <citation>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.</citation>
      <PMID>36674060</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Institut et Haute Ecole de la Santé la Source</investigator_affiliation>
      <investigator_full_name>Meichun Mohler-Kuo, Sc.D</investigator_full_name>
      <investigator_title>Sc.D. Professeur Ordinaire HES-SO</investigator_title>
    </responsible_party>
    <keyword>mental health first aid;</keyword>
    <keyword>undergraduate students;</keyword>
    <keyword>RCT</keyword>
    <keyword>intervention</keyword>
    <keyword>education program</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06035770
  org study id: 2019-01296
  nct id: NCT06035770
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Control trial with educational intervention
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Level of knowledge-(changes were assessed at 3 and 12 months)
  time frame: 3 months; 12 months
  description: 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.
  measure: Level of attitudes pertaining to mental illness (changes were assessed at 3 and 12 months)
  time frame: 3 months; 12 months
  description: to measure changes of participants' level of stigmatization and social distance toward mental illness. Changes of before and after the intervention are also assessed.
  measure: behaviors toward mental illness (changes are assessed at 3 and 12 months))
  time frame: 3 months; 12 months
  description: to measure participants' confidence and intention to provide help and the changes before and after the MHFA are also assessed.
  measure: mental health-quality of life (changes were assessed assessed at 3 and 12 months)
  time frame: 3 months; 12 months
  description: Quality of life using Short-Form Health Survey (SF-12) and change of quality of life were assessed.
  measure: mental health-depression (changes were assessed at 3 and 12 months)
  time frame: 3 months; 12 months
  description: Depression symptoms ( using Patient Health Questionnaire (Brief PHQ-9) and change of depression symptoms were assessed.
  measure: change of mental health-anxiety
  time frame: 3 months; 12 months
  description: Anxiety symptom (using Generalized Anxiety Disorder 7) and changes of anxiety symptoms were assessed.
  measure: change of mental health-ADHD symptoms
  time frame: 3 months; 12 months
  description: ADHD symptoms were assessed using 'ADHD Self-Report Scale (ASRS)' Screener and the change of ADHD symptoms was also assessed.
  arm group label: Mental Health First Aid training program
  arm group type: Experimental
  description: 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.
  arm group label: control group
  arm group type: No Intervention
  description: 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.
  intervention type: Other
  intervention name: Mental Health First Aid (educational training program)
  description: 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.
  arm group label: Mental Health First Aid training program
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Meichun Mohler-Kuo, Sc.D.
  role: Principal Investigator
  affiliation: La Source, School of Nursing Sciences, HES-SO
  facility: 
  country: Switzerland
  citation: 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.
  PMID: 36674060
  responsible party type: Principal Investigator
  investigator affiliation: Institut et Haute Ecole de la Santé la Source
  investigator full name: Meichun Mohler-Kuo, Sc.D
  investigator title: Sc.D. Professeur Ordinaire HES-SO
  sharing ipd: No