NCT06366191

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

April 2, 2024

Last Update Submit

March 17, 2026

Conditions

Psychological Trauma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Adherence of patient to the watch

    1 month after inclusion

  • Adherence of patient to the health watch

    3 months after inclusion

  • Patient satisfaction (quantitatif)

    3 months after inclusion

  • Patient satisfaction (qualitatif)

    3 months after inclusion

  • Strong points of the health watch

    3 months after inclusion

  • +6 more secondary outcomes

Study Arms (2)

Prevention algorithm

EXPERIMENTAL

Patient will have the current support for psychotrauma and psychotrauma prevention algorithm.

Other: prevention algorithm

Current support for psychotrauma

ACTIVE COMPARATOR

Patient will have the current support for psychotrauma.

Other: Standard care

Interventions

prevention algorithmOTHER

a health watch adapted to stress and dissociative symptoms

Prevention algorithm
Standard careOTHER

Standard care for post traumatic stress disorder

Current support for psychotrauma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Trauma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 15, 2024

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03