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Recruiting NCT04701723

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

No phase Interventional Post-traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cardiac coherence.
Who it may be relevant to
Registry conditions: Post-traumatic Stress Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Reunion
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other cardiac coherence
    standard care associated to cardiac coherence training during 3 months

Primary outcome measures

  • Proportion of patients without Post-traumatic stress disorder [Time frame: at month 3]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Reunion · 1 center
  • Etablissement Public de Santé Mentale de La Réunion — Saint-Paul

Identifiers

NCT: NCT04701723 · 2019/CHU/02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗