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

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: Not yet recruiting
• Conditions: Psychological Trauma
• Intervention / Treatment: Other: prevention algorithm; Other: Standard care

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
study acceptability rate	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

Outcome Measure	Measure Description	Time Frame
Adherence of patient to the watch	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	Number of patient contacted by phone having completed the scales divided by number of patient contacted	3 months after inclusion
Patient satisfaction (quantitatif)	A questionnaire will be completed by the patient	3 months after inclusion
Patient satisfaction (qualitatif)	semi-structured interview carried-out in 3 patients volunteers (45 minutes)	3 months after inclusion
Strong points of the health watch	semi-structured interview carried-out in volunteer caregivers (doctor, nurse, psychologist)	3 months after inclusion
Evolution of the patient journey in experimental arm	number an percentage of patient who have changed watch	3 months after inclusion
Occurrence of post-traumatic stress disorder	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	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	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	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	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

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Psychological Trauma; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID 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