ClinicalTrials.gg
RecruitingNCT04701723COHEPS-PUpdated Mar 12, 2026

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

An interventional study of cardiac coherence in Post-traumatic Stress Disorder, sponsored by Centre Hospitalier Universitaire de la Réunion. Recruiting at 1 site in Reunion. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Post-traumatic Stress Disorder
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's planned enrollment of 44 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients seen at medico-psychological emergency cell
  • patients with an acute stress disorder, diagnosed by
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • 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

Interventions

  • Othercardiac coherence

    standard care associated to cardiac coherence training during 3 months

06

What researchers measure

Primary outcomes

  1. Proportion of patients without Post-traumatic stress disorder

    Measured by the Post Traumatic Stress Disorder CheckList for DSM-5 (PCL-5)

    Time frame: at month 3

Secondary outcomes

  1. Complications associated to Post-traumatic stress disorder

    number of suicide attempt

    Time frame: at inclusion

  2. 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

    Time frame: at month 3

  3. Variation in heart rate variability

    measured by time and frequency indices obtained on the tachogram

    Time frame: at inclusion

  4. Variation in heart rate variability

    measured by time and frequency indices obtained on the tachogram

    Time frame: at month 3

  5. Duration of scale completion

    timed

    Time frame: at inclusion

  6. Duration of scale completion

    timed

    Time frame: at month 3

  7. Compliance to Cardiac coherence

    percentage of time spent in cardiac coherence

    Time frame: at inclusion

  8. Compliance to Cardiac coherence

    percentage of time spent in cardiac coherence

    Time frame: at month 1

  9. Compliance to Cardiac coherence

    percentage of time spent in cardiac coherence

    Time frame: at month 2

  10. Compliance to Cardiac coherence

    percentage of time spent in cardiac coherence

    Time frame: at month 3

  11. Proportion of patients who refuse to participate

    all screened patient will be recorded

    Time frame: up to month 3

07

Study locations

1 of 1 sites recruiting
  • Etablissement Public de Santé Mentale de La Réunion
    Saint-Paul, 97460, Reunion
    Recruiting
    • Erick GOKALSING · Contact
    • Erick GOKALSING, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for May 2027, 70 months after the start.

Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 70 months is above that.

Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 23, 2020
First posted
Jan 8, 2021
StartActual
Jul 19, 2021
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Mar 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04701723
Responsible party
Sponsor
First posted
Jan 8, 2021
Start date
Jul 19, 2021
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Mar 12, 2026

Study contacts

Emilie TECHER
Contact
emilie.techer@chu-reunion.fr
+262 262 90 62 89
Erick GOKALSING
principal investigator · Etablissement Public de Santé Mentale de La Réunion

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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