Clinical trial NCT04701723: Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study
Official title: Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients without Post-traumatic stress disorder
timeFrame: at month 3
Secondary outcomes:
measure: Complications associated to Post-traumatic stress disorder
timeFrame: at inclusion
measure: Complications associated to Post-traumatic stress disorder
timeFrame: at month 3
measure: Variation in heart rate variability
timeFrame: at inclusion
measure: Variation in heart rate variability
timeFrame: at month 3
measure: Duration of scale completion
timeFrame: at inclusion
measure: Duration of scale completion
timeFrame: at month 3
measure: Compliance to Cardiac coherence
timeFrame: at inclusion
measure: Compliance to Cardiac coherence
timeFrame: at month 1
measure: Compliance to Cardiac coherence
timeFrame: at month 2
measure: Compliance to Cardiac coherence
timeFrame: at month 3
measure: Proportion of patients who refuse to participate
timeFrame: up to month 3
Other outcomes:
Locations:
city: Saint-Paul
country: Réunion
facility: Etablissement Public de Santé Mentale de La Réunion
Study officials:
affiliation: Etablissement Public de Santé Mentale de La Réunion
name: Erick GOKALSING
role: PRINCIPAL_INVESTIGATOR
References: