Suicidal IdeationInforMedNCT03949556
INternet-based Programmes FOR the Prevention of Suicidal Ideation in MEDical Students
A study testing Videos and/or SMS in people with Suicidal Ideation, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Videos and/or SMS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,544 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Agreement for online clinical assessment
- Having a mobile phone number and an e-mail address
- To be beneficiary of a health insurance programme
Who cannot join
- Refusing to participate
- Protective supervision: curatorship, guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Charles PERRENS
Bordeaux, 33076
Marie TOURNIER, Prof, MD, 003356561771, mtournier@ch-perrens.fr
Helen SAVARIEAU, MSc, 003356563556, hsavarieau@ch-perrens.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicidal Ideation
- Being tested
- Videos and/or SMS
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention program - stress management program | Experimental | This intervention program on stress management is developed to prevent suicidal ideation in medical students and residents. Receives: 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. Receives: 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…. Receives: Other: Videos and/or SMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Jul 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2,544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- MARIE TOURNIER, MD, Prof, Principal investigator, Centre Hospitalier CHARLES PERRENS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949556
- Sponsor's protocol ID
- InforMed
- Acronym
- InforMed
- Status last verified
- Jun 2024
- First submitted
- 13 May 2019
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Programmes for the Prevention of Suicidal Ideation in Medical Students
- ClinicalTrials.gov ID
- NCT03949556
- Acronym / sponsor ID
- InforMed / InforMed
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,544 participants (estimated)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention program - stress management program | Experimental | Other: Videos and/or SMSThis intervention program on stress management is developed to prevent suicidal ideation in medical students and residents. |
| Intervention program - health promotion program | Active comparator | Other: Videos and/or SMSThis intervention program on health promotion is developed to prevent suicidal ideation in medical students and residents. |
| Control condition - general information | Placebo comparator | Other: Videos and/or SMSParticipants 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…. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Refusing to participate
- Protective supervision: curatorship, guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videos and/or SMSParticipants assigned to one of the intervention programmes will watch videos on a website for two months then will receive SMSs for four months. | Other | Control condition - general information, Intervention program - health promotion program, Intervention program - stress management program |
Primary outcome
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.
1 secondary outcome
Suicidal behaviour identified at least once after the intervention.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Suicidal Ideation
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Recruiting
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Depression and Suicide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARIE TOURNIER, MD, Prof principal investigator
Centre Hospitalier CHARLES PERRENS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videos and/or SMS in people with Suicidal Ideation, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARIE TOURNIER, MD, Prof (05 56 56 17 71, mtournier@ch-perrens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal ideation observed at least at one of the three assessment contacts (6, 12, 18 months). (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.