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

NCT04701723 | Recruiting

• 1 other identifier: 2019/CHU/02
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Complications associated to Post-traumatic stress disorder

  at inclusion

• Complications associated to Post-traumatic stress disorder

  at month 3

• Variation in heart rate variability

  at inclusion

• Variation in heart rate variability

  at month 3

• Duration of scale completion

  at inclusion

Study Arms (1)

Cardiac Coherence Training

EXPERIMENTAL

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

Interventions

cardiac coherence OTHER

standard care associated to cardiac coherence training during 3 months

Cardiac Coherence Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 addiction
• patients with a cognitive deficit
• patients under guardianship or curatorship, under judicial supervision

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Etablissement Public de Santé Mentale de La Réunion

Saint-Paul, 97460, Reunion

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Erick GOKALSING

  Etablissement Public de Santé Mentale de La Réunion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie TECHER

CONTACT

+262 262 90 62 89; emilie.techer@chu-reunion.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 8, 2021
• Study Start: July 19, 2021
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)