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

Suicidal Ideation Clinical Trial

— InforMed  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03949556
• Other study ID #: InforMed
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Charles Perrens, Bordeaux
• Contact: MARIE TOURNIER, MD, Prof
• Phone: 05 56 56 17 71
• Email: mtournier[@]ch-perrens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2544
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Charles PERRENS	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Charles Perrens, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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