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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949556
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Charles Perrens, Bordeaux

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
Suicidal Ideation Other: Videos and/or SMS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Internet-based Programmes for the Prevention of Suicidal Ideation in Medical Students
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.




Primary Outcome Measures :
  1. Suicidal ideation observed at least at one of the three assessment contacts (6, 12, 18 months). [ Time Frame: 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.


Secondary Outcome Measures :
  1. Suicidal behaviour identified at least once after the intervention. [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949556


Contacts
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Contact: MARIE TOURNIER, MD, Prof 05 56 56 17 71 mtournier@ch-perrens.fr
Contact: HELEN SAVARIEAU 05 56 56 35 56 hsavarieau@ch-perrens.fr

Locations
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France
Centre Hospitalier Charles PERRENS
Bordeaux, France, 33076
Contact: Marie TOURNIER, Prof, MD    003356561771    mtournier@ch-perrens.fr   
Contact: Helen SAVARIEAU, MSc    003356563556    hsavarieau@ch-perrens.fr   
Sponsors and Collaborators
Centre Hospitalier Charles Perrens, Bordeaux
Investigators
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Principal Investigator: MARIE TOURNIER, MD, Prof Centre Hospitalier CHARLES PERRENS
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Responsible Party: Centre Hospitalier Charles Perrens, Bordeaux
ClinicalTrials.gov Identifier: NCT03949556    
Other Study ID Numbers: InforMed
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms