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INternet-based Programmes FOR the Prevention of Suicidal Ideation in MEDical Students (InforMed)

Primary Purpose

Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Videos and/or SMS
Sponsored by
Centre Hospitalier Charles Perrens, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being registered in the fourth year of medical studies or in the first year of residency (internship), as they appear as two critical periods over medical studies
  • Being registered in the i-Share cohort
  • 18 year-old and over
  • Speaking and reading French
  • Having given an informed consent
  • Ability to understand the type, the aims and the methodology of the study
  • Agreement for online clinical assessment
  • Having a mobile phone number and an e-mail address
  • To be beneficiary of a health insurance programme

Exclusion Criteria:

  • Refusing to participate
  • Protective supervision: curatorship, guardianship

Sites / Locations

  • Centre Hospitalier Charles PERRENSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Intervention program - stress management program

Intervention program - health promotion program

Control condition - general information

Arm Description

This intervention program on stress management is developed to prevent suicidal ideation in medical students and residents.

This intervention program on health promotion is developed to prevent suicidal ideation in medical students and residents.

Participants will receive weekly emails and SMSs, over the same periods of time, with general information about health except mental health, e.g. prevention of melanoma, dental care….

Outcomes

Primary Outcome Measures

Suicidal ideation observed at least at one of the three assessment contacts (6, 12, 18 months).
The electronic Columbia-Suicide Severity Rating Scale (e-CSSRS) will be used to investigate suicide ideation & behaviors. Questionnaire was developped with NIMH support to screen & quantify suicide risk using consecutive questions. No score is computed when using this scale. Questionnaire investigates suicide ideation using several questions (response yes/no): Have you wish you were dead? Have you actually had any thought of killing yourself? If 1 and/or 2 are answered "yes", 4 other questions are asked. For this study, suicide ideation will be considered as a "yes" answered to question 1 or 2.

Secondary Outcome Measures

Suicidal behaviour identified at least once after the intervention.
The electronic Columbia-Suicide Severity Rating Scale (e-CSSRS) will be used to investigate suicide ideation and behaviors. This questionnaire was developped with NIMH support to screen and quantify suicide risk using consecutive questions. No score is computed when using this scale. The questionnaire investigates also suicide behaviours using questions (response yes/no) on actual attempt (have you made a suicide attempt? Have you done anything to harm yourself? have you done anything dangerous where you could have died?) interrupted attempt aborted or self-interrupted attempt preparatory acts or behavior For the present study, suicide behavior will be considered as a "yes" to any of these 4 questions.

Full Information

First Posted
May 13, 2019
Last Updated
March 29, 2023
Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03949556
Brief Title
INternet-based Programmes FOR the Prevention of Suicidal Ideation in MEDical Students
Acronym
InforMed
Official Title
Internet-based Programmes for the Prevention of Suicidal Ideation in Medical Students
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Charles Perrens, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Two programmes have been built to prevent suicidal ideation; one focuses on stress management based on cognitive and behavioural principles and the other on health promotion.
Detailed Description
The main objective will be assessing their respective effectiveness on suicidal ideation (at least one occurrence over a 12-month period after the end of the intervention), through a randomized controlled trial, in medical students and interns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An open three-arm randomized controlled trial will be conducted to assess the effectiveness of two programmes of suicide prevention in fourth-year medical students and first-year interns; one based on stress management using cognitive and behavioural principles and the other on health promotion. Their respective effectiveness will be compared with a control condition. Participants will be assessed using validated questionnaires online at inclusion (before intervention) and at 6 (end of the intervention), 12, and 18 months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2544 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention program - stress management program
Arm Type
Experimental
Arm Description
This intervention program on stress management is developed to prevent suicidal ideation in medical students and residents.
Arm Title
Intervention program - health promotion program
Arm Type
Active Comparator
Arm Description
This intervention program on health promotion is developed to prevent suicidal ideation in medical students and residents.
Arm Title
Control condition - general information
Arm Type
Placebo Comparator
Arm Description
Participants will receive weekly emails and SMSs, over the same periods of time, with general information about health except mental health, e.g. prevention of melanoma, dental care….
Intervention Type
Other
Intervention Name(s)
Videos and/or SMS
Intervention Description
Participants assigned to one of the intervention programmes will watch videos on a website for two months then will receive SMSs for four months.
Primary Outcome Measure Information:
Title
Suicidal ideation observed at least at one of the three assessment contacts (6, 12, 18 months).
Description
The electronic Columbia-Suicide Severity Rating Scale (e-CSSRS) will be used to investigate suicide ideation & behaviors. Questionnaire was developped with NIMH support to screen & quantify suicide risk using consecutive questions. No score is computed when using this scale. Questionnaire investigates suicide ideation using several questions (response yes/no): Have you wish you were dead? Have you actually had any thought of killing yourself? If 1 and/or 2 are answered "yes", 4 other questions are asked. For this study, suicide ideation will be considered as a "yes" answered to question 1 or 2.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Suicidal behaviour identified at least once after the intervention.
Description
The electronic Columbia-Suicide Severity Rating Scale (e-CSSRS) will be used to investigate suicide ideation and behaviors. This questionnaire was developped with NIMH support to screen and quantify suicide risk using consecutive questions. No score is computed when using this scale. The questionnaire investigates also suicide behaviours using questions (response yes/no) on actual attempt (have you made a suicide attempt? Have you done anything to harm yourself? have you done anything dangerous where you could have died?) interrupted attempt aborted or self-interrupted attempt preparatory acts or behavior For the present study, suicide behavior will be considered as a "yes" to any of these 4 questions.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being registered in the fourth year of medical studies or in the first year of residency (internship), as they appear as two critical periods over medical studies Being registered in the i-Share cohort 18 year-old and over Speaking and reading French Having given an informed consent Ability to understand the type, the aims and the methodology of the study Agreement for online clinical assessment Having a mobile phone number and an e-mail address To be beneficiary of a health insurance programme Exclusion Criteria: Refusing to participate Protective supervision: curatorship, guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARIE TOURNIER, MD, Prof
Phone
05 56 56 17 71
Email
mtournier@ch-perrens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
HELEN SAVARIEAU
Phone
05 56 56 35 56
Email
hsavarieau@ch-perrens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIE TOURNIER, MD, Prof
Organizational Affiliation
Centre Hospitalier CHARLES PERRENS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Charles PERRENS
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie TOURNIER, Prof, MD
Phone
003356561771
Email
mtournier@ch-perrens.fr
First Name & Middle Initial & Last Name & Degree
Helen SAVARIEAU, MSc
Phone
003356563556
Email
hsavarieau@ch-perrens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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INternet-based Programmes FOR the Prevention of Suicidal Ideation in MEDical Students

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