Menu
Not yet recruiting NCT06366191

Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study

No phase Interventional Psychological Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: prevention algorithm, Standard care.
Who it may be relevant to
Registry conditions: Psychological Trauma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other prevention algorithm
    a health watch adapted to stress and dissociative symptoms
  • Other Standard care
    Standard care for post traumatic stress disorder

Primary outcome measures

  • study acceptability rate [Time frame: 6 months after inclusion]
Secondary outcome measures (11)
  • Adherence of patient to the watch [Time frame: 1 month after inclusion]
  • Adherence of patient to the health watch [Time frame: 3 months after inclusion]
  • Patient satisfaction (quantitatif) [Time frame: 3 months after inclusion]
  • Patient satisfaction (qualitatif) [Time frame: 3 months after inclusion]
  • Strong points of the health watch [Time frame: 3 months after inclusion]
  • Evolution of the patient journey in experimental arm [Time frame: 3 months after inclusion]
  • Occurrence of post-traumatic stress disorder [Time frame: 3 months after inclusion]
  • Complications associated with post-traumatic stress disorder [Time frame: at inclusion]
  • Complications associated with post-traumatic stress disorder [Time frame: 3 months after inclusion]
  • Complications associated with post-traumatic stress disorder [Time frame: 3 months after inclusion]
  • Complications associated with post-traumatic stress disorder [Time frame: 3 months after inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06366191 · 2023/CHU/08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗