Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study

Study Overview
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Brief Summary
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ThThe aim of this study is to determinate the potential benefits of a respiratory training program (cardiac coherence, CC) in patients suffering from acute stress disorder, after a potentially traumatic event. Using this method is supposed to prevent the onset of chronic post traumatic stress disorder after 3 months. This pilot study will help to determinate the need of developing this kind of complementary and alternative program, and will also provide knowledge about the feasibiility and acceptability of this program for the patients.

Detailed Description
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Each patient will be teached how to use cardiac coherence with a trained practitioner at the inclusion visit. A respiratory guide on smartphone will be given to the patient aswell as a diary in order to keep tracks of the patient's compliance to this program.

Official Title
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Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Other: cardiac coherence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients seen at medico-psychological emergency cell patients with an acute stress disorder, diagnosed by DSM-5 patients who have experienced a potentially traumatic event for the last 3-15 days (vctim or witness) patients able to read and write in French language person affiliated or beneficiary of a social security scheme. person who agrees to participate in the study Exclusion Criteria: patients with respiratory pathology not allowing cardiac coherence training patients currently practicing a regular respiratory control technique or within the last 6 months patients taking beta-blocker, betamimetic, anti-arrhythmic, opioid, antidepressant patients with a pacemaker or suffering from severe cardiac illness patients with non-stabilized psychiatric disorder at inclusion patient taking benzodiazepine unable to wean off in the week following the inclusion patients with addiction patients with a cognitive deficit patients under guardianship or curatorship, under judicial supervision

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Coherence Training<br>The cardiac coherence training will consist in the realization during 3 months by the patient, at home : of 6 respiratory cycles by minute (inspiration : 4,5 seconds/expiration : 5,5 seconds), during 5 minutes, 3 times a day (morning, late morning and late afternoon) | Other: cardiac coherence<br>* standard care associated to cardiac coherence training during 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients without Post-traumatic stress disorder | Measured by the Post Traumatic Stress Disorder CheckList for DSM-5 (PCL-5) | at month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications associated to Post-traumatic stress disorder | number of suicide attempt | at inclusion | 
| Complications associated to Post-traumatic stress disorder | Variation of suicidal risk (Columbia-Suicide Severity Rating Scale or C-SSRS). This scale measure the risk of suicide et will be measured by un external evaluator | at month 3 | 
| Variation in heart rate variability | measured by time and frequency indices obtained on the tachogram | at inclusion | 
| Variation in heart rate variability | measured by time and frequency indices obtained on the tachogram | at month 3 | 
| Duration of scale completion | timed | at inclusion | 
| Duration of scale completion | timed | at month 3 | 
| Compliance to Cardiac coherence | percentage of time spent in cardiac coherence | at inclusion | 
| Compliance to Cardiac coherence | percentage of time spent in cardiac coherence | at month 1 | 
| Compliance to Cardiac coherence | percentage of time spent in cardiac coherence | at month 2 | 
| Compliance to Cardiac coherence | percentage of time spent in cardiac coherence | at month 3 | 
| Proportion of patients who refuse to participate | all screened patient will be recorded | up to month 3 |