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

Not Applicable

Recruiting

• Conditions: Post-traumatic Stress Disorder
• Interventions: Other: cardiac coherence

• Registration Number: NCT04701723
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Study Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Study Start: 2021-07-19
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29
• Primary Completion: 2024-05
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac Coherence Training	cardiac coherence	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)

Primary Outcome Measures

Name	Time	Method
Proportion of patients without Post-traumatic stress disorder	at month 3	Measured by the Post Traumatic Stress Disorder CheckList for DSM-5 (PCL-5)

Secondary Outcome Measures

Name	Time	Method
Complications associated to Post-traumatic stress disorder	at month 3	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
Variation in heart rate variability	at month 3	measured by time and frequency indices obtained on the tachogram
Proportion of patients who refuse to participate	up to month 3	all screened patient will be recorded
Duration of scale completion	at month 3	timed
Compliance to Cardiac coherence	at month 3	percentage of time spent in cardiac coherence

Trial Locations

Locations (1)

Etablissement Public de Santé Mentale de La Réunion; 🇷🇪 Saint-Paul, Réunion