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Clinical Trial NCT04701723 (COHEPS-P) for Post-traumatic Stress Disorder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study (COHEPS-P) 44 Prevention

Recruiting
Clinical Trial NCT04701723 (COHEPS-P) is an interventional study for Post-traumatic Stress Disorder that is recruiting. It started on July 19, 2021 with plans to enroll 44 participants. Led by Centre Hospitalier Universitaire de la Réunion, it is expected to complete by May 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 12, 2026.
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 alte...

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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.
Official Title

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

Conditions
Post-traumatic Stress Disorder
Other Study IDs
  • COHEPS-P
  • 2019/CHU/02
NCT ID Number
NCT04701723
Start Date (Actual)
2021-07-19
Last Update Posted
2026-03-12
Completion Date (Estimated)
2027-05
Enrollment (Estimated)
44
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCardiac 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)
cardiac coherence
standard care associated to cardiac coherence training during 3 months
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Centre Hospitalier Universitaire de la Réunion logoCentre Hospitalier Universitaire de la Réunion
Study Central Contact
Contact: Emilie TECHER, +262 262 90 62 89, [email protected]
1 Study Locations in 1 Countries
Etablissement Public de Santé Mentale de La Réunion, Saint-Paul, 97460, Reunion
Erick GOKALSING, Contact
Erick GOKALSING, MD, Principal Investigator
Recruiting