Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study

Psychological Trauma Clinical Trial

— A2P  

Official title:

Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366191
• Other study ID #: 2023/CHU/08
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychological Trauma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence of patient to the watch	Number of patient contacted by phone having completed the scales divided by number of patient contacted.	1 month after inclusion
Secondary	Adherence of patient to the health watch	Number of patient contacted by phone having completed the scales divided by number of patient contacted	3 months after inclusion
Secondary	Patient satisfaction (quantitatif)	A questionnaire will be completed by the patient	3 months after inclusion
Secondary	Patient satisfaction (qualitatif)	semi-structured interview carried-out in 3 patients volunteers (45 minutes)	3 months after inclusion
Secondary	Strong points of the health watch	semi-structured interview carried-out in volunteer caregivers (doctor, nurse, psychologist)	3 months after inclusion
Secondary	Evolution of the patient journey in experimental arm	number an percentage of patient who have changed watch	3 months after inclusion
Secondary	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	3 months after inclusion
Secondary	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.	at inclusion
Secondary	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.	3 months after inclusion
Secondary	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	3 months after inclusion
Secondary	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	3 months after inclusion