Motivational Interviewing Training for Medical Students: a Pilot Pre-post Study (FEMEM)

September 15, 2017 updated by: DR ANTOINE CHERET, Bicetre Hospital

Optimising the Relationship Between Medical Students and Patients Through a Motivational Interviewing Training Programme: a Pilot Pre-post Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Students in clinical internships (fourth or fifth year of medical courses) in the Immunology-Infection-Inflammation-Endocrinology Division of Bicêtre Hospital, Assistance Publique Hôpitaux de Paris.
  • signed consent

Exclusion Criteria:

  • participation refused
  • prior training in motivational interviewing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: First group
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.
Behavioral: motivationnal interviewing training

The students received three four-hour sessions of basic motivationnal interviewing training :

  1. Viewing and commenting on video clips illustrating motivational and non-motivational doctor-patient interactions.
  2. Lectures and the distribution of memory aids.
  3. Practical exercises: making "reflections", asking open questions; exploring ambivalence; dealing with resistance; expressing empathy, summarising.
  4. 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.
Other: Second group
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.
Behavioral: motivationnal interviewing training

The students received three four-hour sessions of basic motivationnal interviewing training :

  1. Viewing and commenting on video clips illustrating motivational and non-motivational doctor-patient interactions.
  2. Lectures and the distribution of memory aids.
  3. Practical exercises: making "reflections", asking open questions; exploring ambivalence; dealing with resistance; expressing empathy, summarising.
  4. 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
GLOBAL MITI scores (MITI = Motivational Interviewing Treatment Integrity version 3.1.1)
Time Frame: 15 mn
Global scores by two independent raters who used the Motivational Interviewing Treatment Integrity (MITI) 3.1.1 code
15 mn
perception of student's empathy by the caregivers
Time Frame: 15 mn
CARE questionnaire (CARE = The Consultation And Relational Empathy questionnaire)
15 mn
self-efficacy of students to engage in a patient-centred relationship
Time Frame: 15 mn
SEPCQ score (SEPCQ = The self-efficacy in patient-centeredness score)
15 mn
student's satisfaction with the odds of achieving the target goal.
Time Frame: 15 mn
specific questionnary (Analog scale of satisfaction from 1 (not satisfied) to 10 (very statisfied))
15 mn

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bicetre Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Paris 5 - Rene Descartes
INSERM SC10-US19

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ANTOINE CHERET, Bicetre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FEMEM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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