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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Other: cardiac coherence

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie TECHER; Phone Number: +262 262 90 62 89; Email: emilie.techer@chu-reunion.fr

Study Locations

• Réunion
  • Saint-Paul, Réunion, 97460
    • Recruiting
    • Etablissement Public de Santé Mentale de La Réunion
    • Contact: Erick GOKALSING
    • Principal Investigator: Erick GOKALSING, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Coherence Training; 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; standard care associated to cardiac coherence training during 3 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Erick GOKALSING, Etablissement Public de Santé Mentale de La Réunion

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2019/CHU/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No