Clinical Study About the Effects of Scuba Diving on Post Traumatic Stress Disorder (PTSD) (DIVE4NICE)

Clinical Study: Physiological Effects of Scuba Diving on PTSD by Activating the Parasympathetic System and Restoring the Optimal and Sustainable State of Balance Between the Sympathetic and Parasympathetic Autonomous Nervous System (Sympatho-vagale Scale)

Post-traumatic stress disorder (PTSD) is a set of symptoms that can be developed as a result of exposure to a traumatic event or events that can range in prevalence from 25% to 75%. While therapeutic management combines psychotherapy, drug therapy and social support, some PTSD remain resistant after early and appropriate initial treatment. In terms of physiopathology, several studies have shown that parasympathetic activity is significantly decreased in patients with PTSD. In scuba diving, the cardio-vascular stresses associated with submersion of the subject and the lungs due to breathing in a regulator are at the origin of a reflex activation of the parasympathetic nervous system. The objective is to study the effects of the scuba diving activities-induced autonomic parasympathetic nervous system activation on the symptomatic progression of patients with PTSD.

The study population will consist of patients monitored and treated for PTSD following the attacks of 14/07/2016 in Nice (France).

Study Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Other: Scuba diving activities; Other: Virtual reality activities

Detailed Description

A group will be composed of patients (n=12) who will complete a Scuba Diving Discovery Course (GP+ Diving Group). This course, lasting 2 weeks, will consist of a daily dive, 5 days per week, for a total of 10 dives. These will be supervised by a graduate instructor according to the rules of supervision defined by the sport code. The dives will be conducted in open air, at a maximum depth of 6 meters for a maximum duration of 20 minutes.

A matched group (gender, age, height, weight and BMI) will be composed of patients (n=12) who will not complete the Scuba Diving Discovery Course (GP- Virtual reality group). The subjects of this group will follow virtual reality sessions recreating the environment in which the scuba divers of the GP+ group operate. A control group (GT) will be composed of patients (n=12) who are monitored and treated for PTSD and who will not attend the dive discovery course or virtual reality sessions.

• The main evaluation criterion will be the NON-INVASIVE determination of salivary alpha amylase.
• Secondary evaluation criteria will be heart rate variation, CGI, HAD and BECK Anxiety, EGF, PCL-S and IES questionary.

The main objective is to study the effects of immersion and pressure relief ventilation on the activation of the autonomic parasympathetic nervous system.

Secondary objectives are to assess the symptomatic impact of parasympathetic autonomic nervous system activation on overall improvement, anxiety and depressive symptoms, functioning, and the 3 subtypes of PTSD symptoms as vegetative neuro hyperactivity, invasive syndrome and avoiding

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients
• Patients who understand and read French
• Patients who have signed the informed consent form
• Patients who have never practiced scuba diving
• Patients medically fit for scuba diving
• Patients with the DSM-5 criteria for Post-traumatic Stress Disorder
• PCL-S score strictly greater than 44
• CGI greater than or equal to 4
• Chronicity (duration greater than 3 months)

Exclusion Criteria:

• Women of reproductive age without contraception
• Pregnant or nursing women
• Patients under guardianship or curatorship and detainees of justice
• Patients who previously practised scuba diving or hold a diving certificate
• Patients whose medical condition medically contraindicated the practice of scuba diving,
• Patients having a water phobia, bipolar or psychotic disorder
• Patients with a severe and proven suicidal risk (MINI-S and medical examination)
• Patients treated for less than 2 months with antidepressants;
• Patients treated for less than 2 months with specific psychotherapy (Cognitive and Behavioural Therapy, EMDR)
• Patients with response to treatment (50% decrease in symptoms)
• Contraindications to the practice of virtual reality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diving Group; The subjects of this group daily dive, 5 days per week, for a total of 10 dives at a maximum depth of 6 meters for a maximum duration of 20 minutes in a swimming pool.	Other: Scuba diving activities; The subjects of this group daily dive, 5 days per week, for a total of 10 dives at a maximum depth of 6 meters for a maximum duration of 20 minutes in a swimming pool.
Active Comparator: Virtual reality Group; The subjects of this group will follow virtual reality sessions recreating the environment in which the submarine diver of the GP+ group operates.	Other: Virtual reality activities; The subjects of this group will follow virtual reality sessions recreating the environment in which the submarine diver of the GP+ group operates
No Intervention: Control Group; The subjects of this group will be monitored and treated for PTSD and will not attend the dive discovery course or virtual reality sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The main objective is to study the physiological effects of pressure regulator immersion	Measure of parterial pressure	6 months
The main objective is to study the physiological effects of regulator ventilation on the activation of the parasympathetic autonomic nervous system	Measure of O2 saturation	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Carl WILLEM, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 19-PP-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No