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

• Sponsor: Centre Hospitalier Universitaire de la Réunion (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04701723
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 2.4
• Patients Per Site Per Month: 18.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Stress Disorder	Other: cardiac coherence	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pilot studyPilot study
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study
• Actual Study Start Date: Jul 19, 2021
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; standard care associated to cardiac coherence training during 3 months

Outcome Measures

Primary Outcome Measures

1. Proportion of patients without Post-traumatic stress disorder [at month 3]

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

Secondary Outcome Measures

1. Complications associated to Post-traumatic stress disorder [at inclusion]

   number of suicide attempt

2. Complications associated to Post-traumatic stress disorder [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 [at inclusion]

   measured by time and frequency indices obtained on the tachogram

4. Variation in heart rate variability [at month 3]

   measured by time and frequency indices obtained on the tachogram

5. Duration of scale completion [at inclusion]

   timed

6. Duration of scale completion [at month 3]

   timed

7. Compliance to Cardiac coherence [at inclusion]

   percentage of time spent in cardiac coherence

8. Compliance to Cardiac coherence [at month 1]

   percentage of time spent in cardiac coherence

9. Compliance to Cardiac coherence [at month 2]

   percentage of time spent in cardiac coherence

10. Compliance to Cardiac coherence [at month 3]

    percentage of time spent in cardiac coherence

11. Proportion of patients who refuse to participate [up to month 3]

    all screened patient will be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Etablissement Public de Santé Mentale de La Réunion	Saint-Paul		Réunion	97460

Sponsors and Collaborators

• Centre Hospitalier Universitaire de la Réunion

Investigators

• Principal Investigator: Erick GOKALSING, Etablissement Public de Santé Mentale de La Réunion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de la Réunion
• ClinicalTrials.gov Identifier: NCT04701723
• Other Study ID Numbers: 2019/CHU/02
• First Posted: Jan 8, 2021
• Last Update Posted: Aug 3, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Aug 3, 2021