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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Suicidal Ideation

Intervention / Treatment
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* Other: Videos and/or SMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention program - stress management program<br>This intervention program on stress management is developed to prevent suicidal ideation in medical students and residents. | Other: Videos and/or SMS<br>* Participants assigned to one of the intervention programmes will watch videos on a website for two months then will receive SMSs for four months.<br>|
| Active Comparator: Intervention program - health promotion program<br>This intervention program on health promotion is developed to prevent suicidal ideation in medical students and residents. | Other: Videos and/or SMS<br>* Participants assigned to one of the intervention programmes will watch videos on a website for two months then will receive SMSs for four months.<br>|
| Placebo Comparator: Control condition - general information<br>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<br>* Participants assigned to one of the intervention programmes will watch videos on a website for two months then will receive SMSs for four months.<br>|

What is the study measuring?
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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 |