Psychological TraumaA2PNCT06366191
Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study
A study testing prevention algorithm in people with Psychological Trauma, run by Centre Hospitalier Universitaire de la Réunion.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Trauma
- What is being tested?
- prevention algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- having signed a consent
- Non-inclusion Criteria:
- guardianship or curatorship
- unable to receive phone calls
- unable to go to a place for consultation
Who cannot join
None listed.
About this 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.
- Conditions
- Psychological Trauma
- Being tested
- prevention algorithm, Standard care
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prevention algorithmOther
a health watch adapted to stress and dissociative symptoms
Standard careOther
Standard care for post traumatic stress disorder
| Study group | Role | What they receive |
|---|---|---|
| Prevention algorithm | Experimental | Patient will have the current support for psychotrauma and psychotrauma prevention algorithm. Receives: Other: prevention algorithm |
| Current support for psychotrauma | Active comparator | Patient will have the current support for psychotrauma. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after inclusion
Secondary outcomes (11)
Adherence of patient to the watch
Number of patient contacted by phone having completed the scales divided by number of patient contacted.
Measured: 1 month after inclusion
Adherence of patient to the health watch
Number of patient contacted by phone having completed the scales divided by number of patient contacted
Measured: 3 months after inclusion
Patient satisfaction (quantitatif)
A questionnaire will be completed by the patient
Measured: 3 months after inclusion
Patient satisfaction (qualitatif)
semi-structured interview carried-out in 3 patients volunteers (45 minutes)
Measured: 3 months after inclusion
Strong points of the health watch
semi-structured interview carried-out in volunteer caregivers (doctor, nurse, psychologist)
Measured: 3 months after inclusion
Evolution of the patient journey in experimental arm
number an percentage of patient who have changed watch
Measured: 3 months after inclusion
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
Measured: 3 months after inclusion
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.
Measured: at inclusion
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.
Measured: 3 months after inclusion
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
Measured: 3 months after inclusion
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
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366191
- Sponsor's protocol ID
- 2023/CHU/08
- Acronym
- A2P
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06366191
- Acronym / sponsor ID
- A2P / 2023/CHU/08
- Conditions
- Psychological Trauma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention algorithm | Experimental | Other: prevention algorithmPatient will have the current support for psychotrauma and psychotrauma prevention algorithm. |
| Current support for psychotrauma | Active comparator | Other: Standard carePatient will have the current support for psychotrauma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prevention algorithma health watch adapted to stress and dissociative symptoms | Other | Prevention algorithm |
| Standard careStandard care for post traumatic stress disorder | Other | Current support for psychotrauma |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing prevention algorithm in people with Psychological Trauma, run by Centre Hospitalier Universitaire de la Réunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study acceptability rate (time frame: 6 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.