NCT04343924

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

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

Conditions

• Post-traumatic Stress Disorder

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2023-02-07
• Primary completion: 2023-09-27
• Completion: 2023-10-20
• First posted: 2020-04-14
• Last updated: 2024-01-12

Locations

1 site across 1 country: France