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

NCT04343924 | Completed

• 1 other identifier: 19-PP-12
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Diving Group

EXPERIMENTAL

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

Virtual reality Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

The subjects of this group will be monitored and treated for PTSD and will not attend the dive discovery course or virtual reality sessions.

Interventions

Scuba diving activities OTHER

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.

Diving Group

Virtual reality activities OTHER

The subjects of this group will follow virtual reality sessions recreating the environment in which the submarine diver of the GP+ group operates

Virtual reality Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Carl WILLEM

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 14, 2020
• Study Start: February 7, 2023
• Primary Completion: September 27, 2023
• Study Completion: October 20, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)