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Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study

Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06366191
Acronym
A2P
Enrollment
40
Registered
2024-04-15
Start date
2026-10-01
Completion date
2026-11-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Trauma

Brief summary

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.

Interventions

a health watch adapted to stress and dissociative symptoms

OTHERStandard care

Standard care for post traumatic stress disorder

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
study acceptability rate6 months after inclusionNumber of included patient divided by number of patients to whom the study was offered. Study acceptability rate of 50% is expected.

Secondary

MeasureTime frameDescription
Adherence of patient to the watch1 month after inclusionNumber of patient contacted by phone having completed the scales divided by number of patient contacted.
Adherence of patient to the health watch3 months after inclusionNumber of patient contacted by phone having completed the scales divided by number of patient contacted
Patient satisfaction (quantitatif)3 months after inclusionA questionnaire will be completed by the patient
Patient satisfaction (qualitatif)3 months after inclusionsemi-structured interview carried-out in 3 patients volunteers (45 minutes)
Strong points of the health watch3 months after inclusionsemi-structured interview carried-out in volunteer caregivers (doctor, nurse, psychologist)
Evolution of the patient journey in experimental arm3 months after inclusionnumber an percentage of patient who have changed watch
Occurrence of post-traumatic stress disorder3 months after inclusionEvaluation 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
Complications associated with post-traumatic stress disorderat inclusionassessed by C-SSRS (Columbia-Suicide Severity Rating Scale). Assessment of suicide risk in patient. No score for this scale.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026