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NCT Number: NCT06366191

Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study

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.

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Key information

Conditions

Psychological Trauma Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prevention algorithm

Other

a health watch adapted to stress and dissociative symptoms

Standard care

Other

Standard care for post traumatic stress disorder

Primary outcomes

  1. study acceptability rate

    Time frame: 6 months after inclusion

    Number of included patient divided by number of patients to whom the study was offered.

    Study acceptability rate of 50% is expected.

Secondary outcomes

  1. Adherence of patient to the watch

    Time frame: 1 month after inclusion

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

  2. Adherence of patient to the health watch

    Time frame: 3 months after inclusion

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

  3. Patient satisfaction (quantitatif)

    Time frame: 3 months after inclusion

    A questionnaire will be completed by the patient

  4. Patient satisfaction (qualitatif)

    Time frame: 3 months after inclusion

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

  5. Strong points of the health watch

    Time frame: 3 months after inclusion

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

  6. Evolution of the patient journey in experimental arm

    Time frame: 3 months after inclusion

    number an percentage of patient who have changed watch

  7. Occurrence of post-traumatic stress disorder

    Time frame: 3 months after inclusion

    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

  8. Complications associated with post-traumatic stress disorder

    Time frame: at inclusion

    assessed by C-SSRS (Columbia-Suicide Severity Rating Scale). Assessment of suicide risk in patient. No score for this scale.

  9. Complications associated with post-traumatic stress disorder

    Time frame: 3 months after inclusion

    assessed by C-SSRS (Columbia-Suicide Severity Rating Scale). Assessment of suicide risk in patient. No score for this scale.

  10. Complications associated with post-traumatic stress disorder

    Time frame: 3 months after inclusion

    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

  11. Complications associated with post-traumatic stress disorder

    Time frame: 3 months after inclusion

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: A2P

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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