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NCT Number: NCT04701723

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Etablissement Public de Santé Mentale de La Réunion

Saint-Paul, 97460, Reunion

Location status: Recruiting

Location contact

Erick GOKALSING

CONTACT

Erick GOKALSING, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac coherence

Other

standard care associated to cardiac coherence training during 3 months

Primary outcomes

  1. 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)

Secondary outcomes

  1. Complications associated to Post-traumatic stress disorder

    Time frame: at inclusion

    number of suicide attempt

  2. Complications associated to Post-traumatic stress disorder

    Time frame: 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

  3. Variation in heart rate variability

    Time frame: at inclusion

    measured by time and frequency indices obtained on the tachogram

  4. Variation in heart rate variability

    Time frame: at month 3

    measured by time and frequency indices obtained on the tachogram

  5. Duration of scale completion

    Time frame: at inclusion

    timed

  6. Duration of scale completion

    Time frame: at month 3

    timed

  7. Compliance to Cardiac coherence

    Time frame: at inclusion

    percentage of time spent in cardiac coherence

  8. Compliance to Cardiac coherence

    Time frame: at month 1

    percentage of time spent in cardiac coherence

  9. Compliance to Cardiac coherence

    Time frame: at month 2

    percentage of time spent in cardiac coherence

  10. Compliance to Cardiac coherence

    Time frame: at month 3

    percentage of time spent in cardiac coherence

  11. Proportion of patients who refuse to participate

    Time frame: up to month 3

    all screened patient will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie TECHER

CONTACT

[email protected]

+262 262 90 62 89

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: COHEPS-P

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2021
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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