Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study (A2P)

March 17, 2026 updated by: Centre Hospitalier Universitaire de la Réunion
A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Person who the vital prognosis has or could have been committed or having felt a threat to his physical and/or psychological integrity
  • After a potentially traumatic event dating from a minimum of 72 hours to a maximum of 1 week
  • for which the CUMP or the psychotrauma regulation platform has been requested
  • having lived or being a direct witness of the event
  • knowing how to read and write
  • affiliate or beneficiary of a social security scheme
  • having signed a consent

Non-inclusion Criteria:

  • guardianship or curatorship
  • unable to receive phone calls
  • unable to go to a place for consultation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prevention algorithm
Patient will have the current support for psychotrauma and psychotrauma prevention algorithm.
Other: prevention algorithm
a health watch adapted to stress and dissociative symptoms
Active Comparator: Current support for psychotrauma
Patient will have the current support for psychotrauma.
Other: Standard care
Standard care for post traumatic stress disorder

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
study acceptability rate
Time Frame: 6 months after inclusion

Number of included patient divided by number of patients to whom the study was offered.

Study acceptability rate of 50% is expected.
6 months after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence of patient to the watch
Time Frame: 1 month after inclusion
Number of patient contacted by phone having completed the scales divided by number of patient contacted.
1 month after inclusion
Adherence of patient to the health watch
Time Frame: 3 months after inclusion
Number of patient contacted by phone having completed the scales divided by number of patient contacted
3 months after inclusion
Patient satisfaction (quantitatif)
Time Frame: 3 months after inclusion
A questionnaire will be completed by the patient
3 months after inclusion
Patient satisfaction (qualitatif)
Time Frame: 3 months after inclusion
semi-structured interview carried-out in 3 patients volunteers (45 minutes)
3 months after inclusion
Strong points of the health watch
Time Frame: 3 months after inclusion
semi-structured interview carried-out in volunteer caregivers (doctor, nurse, psychologist)
3 months after inclusion
Evolution of the patient journey in experimental arm
Time Frame: 3 months after inclusion
number an percentage of patient who have changed watch
3 months after inclusion
Occurrence of post-traumatic stress disorder
Time Frame: 3 months after inclusion
Evaluation by Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). Score between 0 and 80. Score < 38 : no post-traumatic stress disorder Score = or > 38 : post-traumatic stress disorder
3 months after inclusion
Complications associated with post-traumatic stress disorder
Time Frame: at inclusion
assessed by C-SSRS (Columbia-Suicide Severity Rating Scale). Assessment of suicide risk in patient. No score for this scale.
at inclusion
Complications associated with post-traumatic stress disorder
Time Frame: 3 months after inclusion
assessed by C-SSRS (Columbia-Suicide Severity Rating Scale). Assessment of suicide risk in patient. No score for this scale.
3 months after inclusion
Complications associated with post-traumatic stress disorder
Time Frame: 3 months after inclusion

assessed by the Hospital Anxiety and Depression Scale (HADS). 1 subscore for anxiety scale (HADS-A) between 0 and 21

1 subscore for depression scale (HADS-D) between 0 and 21 Overall score between 0 and 42 HADS-A + HADS-D scores). Score < or = 7 : no symptom Score = or > 8 : symptom the higher the score, the more severe the symptoms
3 months after inclusion
Complications associated with post-traumatic stress disorder
Time Frame: 3 months after inclusion

assessed by WHO Quality of life - Bref (WHOQOL Bref). This scale assessed 4 domains : physical health, mental health, social relations and the environment.

Overall Score is between 26 and 130. the higher the score, the better the quality of life
3 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de la Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/CHU/08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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