NCT03949556

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,544

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
2.1 years until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

4.3 years

First QC Date

May 13, 2019

Last Update Submit

June 17, 2024

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

  • 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): 1. Have you wish you were dead? 2. 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 Outcomes (1)

  • Suicidal behaviour identified at least once after the intervention.

    18 months

Study Arms (3)

Intervention program - stress management program

EXPERIMENTAL

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

Other: Videos and/or SMS

Intervention program - health promotion program

ACTIVE COMPARATOR

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

Other: Videos and/or SMS

Control condition - general information

PLACEBO COMPARATOR

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

Interventions

Videos and/or SMSOTHER

Participants assigned to one of the intervention programmes will watch videos on a website for two months then will receive SMSs for four months.

Control condition - general informationIntervention program - health promotion programIntervention program - stress management program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Refusing to participate
  • Protective supervision: curatorship, guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Charles PERRENS

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • MARIE TOURNIER, MD, Prof

    Centre Hospitalier CHARLES PERRENS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MARIE TOURNIER, MD, Prof

CONTACT

05 56 56 17 71mtournier@ch-perrens.fr

HELEN SAVARIEAU

CONTACT

05 56 56 35 56hsavarieau@ch-perrens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 14, 2019

Study Start

July 1, 2021

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)