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

Primary Purpose

Post-traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
cardiac coherence
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Etablissement Public de Santé Mentale de La RéunionRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac Coherence Training

Arm Description

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)

Outcomes

Primary Outcome Measures

Proportion of patients without Post-traumatic stress disorder
Measured by the Post Traumatic Stress Disorder CheckList for DSM-5 (PCL-5)

Secondary Outcome Measures

Complications associated to Post-traumatic stress disorder
number of suicide attempt
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
Variation in heart rate variability
measured by time and frequency indices obtained on the tachogram
Variation in heart rate variability
measured by time and frequency indices obtained on the tachogram
Duration of scale completion
timed
Duration of scale completion
timed
Compliance to Cardiac coherence
percentage of time spent in cardiac coherence
Compliance to Cardiac coherence
percentage of time spent in cardiac coherence
Compliance to Cardiac coherence
percentage of time spent in cardiac coherence
Compliance to Cardiac coherence
percentage of time spent in cardiac coherence
Proportion of patients who refuse to participate
all screened patient will be recorded

Full Information

First Posted
December 23, 2020
Last Updated
September 28, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT04701723
Brief Title
Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study
Acronym
COHEPS-P
Official Title
Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Coherence Training
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
cardiac coherence
Intervention Description
standard care associated to cardiac coherence training during 3 months
Primary Outcome Measure Information:
Title
Proportion of patients without Post-traumatic stress disorder
Description
Measured by the Post Traumatic Stress Disorder CheckList for DSM-5 (PCL-5)
Time Frame
at month 3
Secondary Outcome Measure Information:
Title
Complications associated to Post-traumatic stress disorder
Description
number of suicide attempt
Time Frame
at inclusion
Title
Complications associated to Post-traumatic stress disorder
Description
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
Title
Variation in heart rate variability
Description
measured by time and frequency indices obtained on the tachogram
Time Frame
at inclusion
Title
Variation in heart rate variability
Description
measured by time and frequency indices obtained on the tachogram
Time Frame
at month 3
Title
Duration of scale completion
Description
timed
Time Frame
at inclusion
Title
Duration of scale completion
Description
timed
Time Frame
at month 3
Title
Compliance to Cardiac coherence
Description
percentage of time spent in cardiac coherence
Time Frame
at inclusion
Title
Compliance to Cardiac coherence
Description
percentage of time spent in cardiac coherence
Time Frame
at month 1
Title
Compliance to Cardiac coherence
Description
percentage of time spent in cardiac coherence
Time Frame
at month 2
Title
Compliance to Cardiac coherence
Description
percentage of time spent in cardiac coherence
Time Frame
at month 3
Title
Proportion of patients who refuse to participate
Description
all screened patient will be recorded
Time Frame
up to month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie TECHER
Phone
+262 262 90 62 89
Email
emilie.techer@chu-reunion.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erick GOKALSING
Organizational Affiliation
Etablissement Public de Santé Mentale de La Réunion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Etablissement Public de Santé Mentale de La Réunion
City
Saint-Paul
ZIP/Postal Code
97460
Country
Réunion
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erick GOKALSING
First Name & Middle Initial & Last Name & Degree
Erick GOKALSING, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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