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Not yet recruitingNCT06366191A2PUpdated Sep 14, 2026

Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study

An interventional study of prevention algorithm and Standard care in Psychological Trauma, sponsored by Centre Hospitalier Universitaire de la Réunion. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psychological Trauma

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03

In context

Psychological Trauma

140 studies on the registry are indexed under Psychological Trauma; 43 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 108 interventional studies indexed under Psychological Trauma.

Browse Psychological Trauma studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Prevention algorithm

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

    Other: prevention algorithm

  • Active comparator
    Current support for psychotrauma

    Patient will have the current support for psychotrauma.

    Other: Standard care

Interventions

  • Otherprevention algorithm

    a health watch adapted to stress and dissociative symptoms

  • OtherStandard care

    Standard care for post traumatic stress disorder

06

What researchers measure

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.

    Time frame: 6 months after inclusion

Secondary outcomes

  1. Adherence of patient to the watch

    Number of patient contacted by phone having completed the scales divided by number of patient contacted.

    Time frame: 1 month after inclusion

  2. Adherence of patient to the health watch

    Number of patient contacted by phone having completed the scales divided by number of patient contacted

    Time frame: 3 months after inclusion

  3. Patient satisfaction (quantitatif)

    A questionnaire will be completed by the patient

    Time frame: 3 months after inclusion

  4. Patient satisfaction (qualitatif)

    semi-structured interview carried-out in 3 patients volunteers (45 minutes)

    Time frame: 3 months after inclusion

  5. Strong points of the health watch

    semi-structured interview carried-out in volunteer caregivers (doctor, nurse, psychologist)

    Time frame: 3 months after inclusion

  6. Evolution of the patient journey in experimental arm

    number an percentage of patient who have changed watch

    Time frame: 3 months after inclusion

  7. 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

    Time frame: 3 months after inclusion

  8. 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.

    Time frame: at inclusion

  9. 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.

    Time frame: 3 months after inclusion

  10. 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

    Time frame: 3 months after inclusion

  11. 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

    Time frame: 3 months after inclusion

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.

Of 82 non-industry interventional studies with no phase under Psychological Trauma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 1 month is below that.

Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 12 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2024
First posted
Apr 15, 2024
StartEst.
Oct 2026
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06366191
Responsible party
Sponsor
First posted
Apr 15, 2024
Start date
Oct 2026 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Sep 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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