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

Sponsor
Centre Hospitalier Charles Perrens, Bordeaux (Other)
Overall Status
Recruiting
CT.gov ID
NCT03949556
Collaborator
(none)
2,544
1
3
30
84.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Videos and/or SMS
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2544 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Prevention
Official Title:
Internet-based Programmes for the Prevention of Suicidal Ideation in Medical Students
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention program - stress management program

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

Other: Videos and/or SMS
Participants assigned to one of the intervention programmes will watch videos on a website for two months then will receive SMSs for four months.

Active Comparator: Intervention program - health promotion program

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

Other: Videos and/or SMS
Participants assigned to one of the intervention programmes will watch videos on a website for two months then will receive SMSs for four months.

Placebo Comparator: Control condition - general information

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 careā€¦.

Other: Videos and/or SMS
Participants assigned to one of the intervention programmes will watch videos on a website for two months then will receive SMSs for four months.

Outcome Measures

Primary Outcome Measures

  1. Suicidal ideation observed at least at one of the three assessment contacts (6, 12, 18 months). [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

  1. Suicidal behaviour identified at least once after the intervention. [18 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Charles PERRENS Bordeaux France 33076

Sponsors and Collaborators

  • Centre Hospitalier Charles Perrens, Bordeaux

Investigators

  • Principal Investigator: MARIE TOURNIER, MD, Prof, Centre Hospitalier CHARLES PERRENS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Charles Perrens, Bordeaux
ClinicalTrials.gov Identifier:
NCT03949556
Other Study ID Numbers:
  • InforMed
First Posted:
May 14, 2019
Last Update Posted:
Aug 23, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2021