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

Internet-based Programmes for the Prevention of Suicidal Ideation in Medical Students

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.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation
• Intervention / Treatment: Other: Videos and/or SMS

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 Type: Interventional
• Enrollment (Anticipated): 2544
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MARIE TOURNIER, MD, Prof; Phone Number: 05 56 56 17 71; Email: mtournier@ch-perrens.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Recruiting
    • Centre Hospitalier Charles Perrens
    • Contact: Helen SAVARIEAU, MSc; Phone Number: 003356563556; Email: hsavarieau@ch-perrens.fr
    • Contact: Marie TOURNIER, Prof, MD; Phone Number: 003356561771; Email: mtournier@ch-perrens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 care….	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Charles Perrens, Bordeaux
• Investigators: Principal Investigator: MARIE TOURNIER, MD, Prof, Centre Hospitalier Charles Perrens

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: InforMed

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