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

Post-traumatic Stress Disorder Clinical Trial

— COHEPS-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04701723
• Other study ID #: 2019/CHU/02
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Emilie TECHER
• Phone: +262 262 90 62 89
• Email: emilie.techer[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• cardiac coherence
standard care associated to cardiac coherence training during 3 months

Locations

Country	Name	City	State
Réunion	Etablissement Public de Santé Mentale de La Réunion	Saint-Paul

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications associated to Post-traumatic stress disorder	number of suicide attempt	at inclusion
Secondary	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
Secondary	Variation in heart rate variability	measured by time and frequency indices obtained on the tachogram	at inclusion
Secondary	Variation in heart rate variability	measured by time and frequency indices obtained on the tachogram	at month 3
Secondary	Duration of scale completion	timed	at inclusion
Secondary	Duration of scale completion	timed	at month 3
Secondary	Compliance to Cardiac coherence	percentage of time spent in cardiac coherence	at inclusion
Secondary	Compliance to Cardiac coherence	percentage of time spent in cardiac coherence	at month 1
Secondary	Compliance to Cardiac coherence	percentage of time spent in cardiac coherence	at month 2
Secondary	Compliance to Cardiac coherence	percentage of time spent in cardiac coherence	at month 3
Secondary	Proportion of patients who refuse to participate	all screened patient will be recorded	up to month 3