Post-traumatic Stress DisorderCOHEPS-PNCT04701723
Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study
A study testing cardiac coherence in people with Post-traumatic Stress Disorder, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- cardiac coherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteReunion
- Study dates
- 19 Jul 2021to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- patients with addiction
- patients with a cognitive deficit
- patients under guardianship or curatorship, under judicial supervision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reunion1 site, 1 recruiting
- Recruiting
Etablissement Public de Santé Mentale de La Réunion
Saint-Paul, 97460
Erick GOKALSING
Erick GOKALSING, MD
About this study
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.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- cardiac coherence
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac coherenceOther
standard care associated to cardiac coherence training during 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: cardiac coherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients without Post-traumatic stress disorder
Measured by the Post Traumatic Stress Disorder CheckList for DSM-5 (PCL-5)
Measured: at month 3
Secondary outcomes (11)
Complications associated to Post-traumatic stress disorder
number of suicide attempt
Measured: 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
Measured: at month 3
Variation in heart rate variability
measured by time and frequency indices obtained on the tachogram
Measured: at inclusion
Variation in heart rate variability
measured by time and frequency indices obtained on the tachogram
Measured: at month 3
Duration of scale completion
timed
Measured: at inclusion
Duration of scale completion
timed
Measured: at month 3
Compliance to Cardiac coherence
percentage of time spent in cardiac coherence
Measured: at inclusion
Compliance to Cardiac coherence
percentage of time spent in cardiac coherence
Measured: at month 1
Compliance to Cardiac coherence
percentage of time spent in cardiac coherence
Measured: at month 2
Compliance to Cardiac coherence
percentage of time spent in cardiac coherence
Measured: at month 3
Proportion of patients who refuse to participate
all screened patient will be recorded
Measured: up to month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start19 Jul 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erick GOKALSING, Principal investigator, Etablissement Public de Santé Mentale de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701723
- Sponsor's protocol ID
- 2019/CHU/02
- Acronym
- COHEPS-P
- Status last verified
- Mar 2026
- First submitted
- 23 Dec 2020
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study
- ClinicalTrials.gov ID
- NCT04701723
- Acronym / sponsor ID
- COHEPS-P / 2019/CHU/02
- Conditions
- Post-traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Cardiac Coherence Training | Experimental | Other: cardiac coherenceThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac coherencestandard care associated to cardiac coherence training during 3 months | Other | Cardiac Coherence Training |
Primary outcome
Proportion of patients without Post-traumatic stress disorder
Time frame: at month 3
Measured by the Post Traumatic Stress Disorder CheckList for DSM-5 (PCL-5)
11 secondary outcomes
Complications associated to Post-traumatic stress disorder
Time frame: at inclusion
Complications associated to Post-traumatic stress disorder
Time frame: at month 3
Variation in heart rate variability
Time frame: at inclusion
Variation in heart rate variability
Time frame: at month 3
Duration of scale completion
Time frame: at inclusion
Duration of scale completion
Time frame: at month 3
Compliance to Cardiac coherence
Time frame: at inclusion
Compliance to Cardiac coherence
Time frame: at month 1
Compliance to Cardiac coherence
Time frame: at month 2
Compliance to Cardiac coherence
Time frame: at month 3
Proportion of patients who refuse to participate
Time frame: up to month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erick GOKALSING principal investigator
Etablissement Public de Santé Mentale de La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac coherence in people with Post-traumatic Stress Disorder, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie TECHER (+262 262 90 62 89, emilie.techer@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients without Post-traumatic stress disorder (time frame: at month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.