<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/NCT03285828</url>
  </required_header>
  <id_info>
    <org_study_id>FEMEM</org_study_id>
    <nct_id>NCT03285828</nct_id>
  </id_info>
  <brief_title>Motivational Interviewing Training for Medical Students: a Pilot Pre-post Study</brief_title>
  <acronym>FEMEM</acronym>
  <official_title>Optimising the Relationship Between Medical Students and Patients Through a Motivational Interviewing Training Programme: a Pilot Pre-post Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bicetre Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>INSERM SC10-US19</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Paris 5 - Rene Descartes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bicetre Hospital</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>
      Objective is to evaluate the impact of a basic training programme in motivational&#xD;
      interviewing (MI) for medical students, by comparing the ability of students to promote&#xD;
      behavioural changes through relationship skills and to conduct a motivational interview&#xD;
      before and after training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: A pilot pre-post study in 20 students by comparing students' performance before and&#xD;
      after MI training session.&#xD;
&#xD;
      Setting: Bicêtre Hospital, Assistance Publique Hôpitaux de Paris, France.&#xD;
&#xD;
      Interventions: Students received three four-hour sessions of a basic MI training over a one&#xD;
      week period. The students interviewed for 15 minutes a caregiver playing the role of a&#xD;
      patient, six weeks before and three weeks after the training.&#xD;
&#xD;
      Main outcome measures: Global scores by two independent raters who used the Motivational&#xD;
      Interviewing Treatment Integrity (MITI) 3.1.1 code, perception of student's empathy by the&#xD;
      caregivers (CARE questionnaire), self-efficacy of students to engage in a patient-centred&#xD;
      relationship (SEPCQ score), and student's satisfaction with the odds of achieving the target&#xD;
      goal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2016</start_date>
  <completion_date type="Actual">June 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A pilot pre-post study investigating the effects of a training programme, by comparing performance before and after its implementation</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GLOBAL MITI scores (MITI = Motivational Interviewing Treatment Integrity version 3.1.1)</measure>
    <time_frame>15 mn</time_frame>
    <description>Global scores by two independent raters who used the Motivational Interviewing Treatment Integrity (MITI) 3.1.1 code</description>
  </primary_outcome>
  <primary_outcome>
    <measure>perception of student's empathy by the caregivers</measure>
    <time_frame>15 mn</time_frame>
    <description>CARE questionnaire (CARE = The Consultation And Relational Empathy questionnaire)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>self-efficacy of students to engage in a patient-centred relationship</measure>
    <time_frame>15 mn</time_frame>
    <description>SEPCQ score (SEPCQ = The self-efficacy in patient-centeredness score)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>student's satisfaction with the odds of achieving the target goal.</measure>
    <time_frame>15 mn</time_frame>
    <description>specific questionnary (Analog scale of satisfaction from 1 (not satisfied) to 10 (very statisfied))</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Change; Personality, Due to General Medical Condition</condition>
  <arm_group>
    <arm_group_label>First group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Students received three four-hour sessions of a basic motivationnal interviewing training over a one week period. The students interviewed for 15 minutes a caregiver playing the role of a patient, six weeks before and three weeks after the training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Second group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Students received three four-hour sessions of a basic motivationnal interviewing training over a one week period. The students interviewed for 15 minutes a caregiver playing the role of a patient, six weeks before and three weeks after the training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>motivationnal interviewing training</intervention_name>
    <description>The students received three four-hour sessions of basic motivationnal interviewing training :&#xD;
Viewing and commenting on video clips illustrating motivational and non-motivational doctor-patient interactions.&#xD;
Lectures and the distribution of memory aids.&#xD;
Practical exercises: making &quot;reflections&quot;, asking open questions; exploring ambivalence; dealing with resistance; expressing empathy, summarising.&#xD;
Role-playing, based on several situations, each involving two students. The investigators deliberately chose a non-medical situation (conflict between a mother and a student asking her for pocket money to go out for fun, the day before a university examination) for the first situation. All the other situations concerned changes to healthier behaviour in a medical setting, but with a goal different from that used for the first or the second simulated interview before motivationnal interviewing training.</description>
    <arm_group_label>First group</arm_group_label>
    <arm_group_label>Second group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students in clinical internships (fourth or fifth year of medical courses) in the&#xD;
             Immunology-Infection-Inflammation-Endocrinology Division of Bicêtre Hospital,&#xD;
             Assistance Publique Hôpitaux de Paris.&#xD;
&#xD;
          -  signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participation refused&#xD;
&#xD;
          -  prior training in motivational interviewing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ANTOINE CHERET</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bicetre Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Rollnick S, Butler CC, Kinnersley P, Gregory J, Mash B. Motivational interviewing. BMJ. 2010 Apr 27;340:c1900. doi: 10.1136/bmj.c1900. No abstract available.</citation>
    <PMID>20423957</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bicetre Hospital</investigator_affiliation>
    <investigator_full_name>DR ANTOINE CHERET</investigator_full_name>
    <investigator_title>Doctor ANTOINE CHERET</investigator_title>
  </responsible_party>
  <keyword>medical education, motivational interviewing, medical empathy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03285828
org study id: FEMEM
nct id: NCT03285828
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective is to evaluate the impact of a basic training programme in motivational
      interviewing (MI) for medical students, by comparing the ability of students to promote
      behavioural changes through relationship skills and to conduct a motivational interview
      before and after training.
Design: A pilot pre-post study in 20 students by comparing students' performance before and
      after MI training session.

      Setting: Bicêtre Hospital, Assistance Publique Hôpitaux de Paris, France.

      Interventions: Students received three four-hour sessions of a basic MI training over a one
      week period. The students interviewed for 15 minutes a caregiver playing the role of a
      patient, six weeks before and three weeks after the training.

      Main outcome measures: Global scores by two independent raters who used the Motivational
      Interviewing Treatment Integrity (MITI) 3.1.1 code, perception of student's empathy by the
      caregivers (CARE questionnaire), self-efficacy of students to engage in a patient-centred
      relationship (SEPCQ score), and student's satisfaction with the odds of achieving the target
      goal.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: A pilot pre-post study investigating the effects of a training programme, by comparing performance before and after its implementation
primary purpose: Other
masking: Single (Participant)
measure: GLOBAL MITI scores (MITI = Motivational Interviewing Treatment Integrity version 3.1.1)
time frame: 15 mn
description: Global scores by two independent raters who used the Motivational Interviewing Treatment Integrity (MITI) 3.1.1 code
measure: perception of student's empathy by the caregivers
time frame: 15 mn
description: CARE questionnaire (CARE = The Consultation And Relational Empathy questionnaire)
measure: self-efficacy of students to engage in a patient-centred relationship
time frame: 15 mn
description: SEPCQ score (SEPCQ = The self-efficacy in patient-centeredness score)
measure: student's satisfaction with the odds of achieving the target goal.
time frame: 15 mn
description: specific questionnary (Analog scale of satisfaction from 1 (not satisfied) to 10 (very statisfied))
arm group label: First group
arm group type: Other
description: Students received three four-hour sessions of a basic motivationnal interviewing training over a one week period. The students interviewed for 15 minutes a caregiver playing the role of a patient, six weeks before and three weeks after the training.
arm group label: Second group
arm group type: Other
description: Students received three four-hour sessions of a basic motivationnal interviewing training over a one week period. The students interviewed for 15 minutes a caregiver playing the role of a patient, six weeks before and three weeks after the training.
intervention type: Behavioral
intervention name: motivationnal interviewing training
description: The students received three four-hour sessions of basic motivationnal interviewing training :
Viewing and commenting on video clips illustrating motivational and non-motivational doctor-patient interactions.
Lectures and the distribution of memory aids.
Practical exercises: making "reflections", asking open questions; exploring ambivalence; dealing with resistance; expressing empathy, summarising.
Role-playing, based on several situations, each involving two students. The investigators deliberately chose a non-medical situation (conflict between a mother and a student asking her for pocket money to go out for fun, the day before a university examination) for the first situation. All the other situations concerned changes to healthier behaviour in a medical setting, but with a goal different from that used for the first or the second simulated interview before motivationnal interviewing training.
arm group label: First group
arm group label: Second group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: ANTOINE CHERET
role: Principal Investigator
affiliation: Bicetre Hospital
citation: Rollnick S, Butler CC, Kinnersley P, Gregory J, Mash B. Motivational interviewing. BMJ. 2010 Apr 27;340:c1900. doi: 10.1136/bmj.c1900. No abstract available.
PMID: 20423957
responsible party type: Principal Investigator
investigator affiliation: Bicetre Hospital
investigator full name: DR ANTOINE CHERET
investigator title: Doctor ANTOINE CHERET
sharing ipd: No