The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343924
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : January 12, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Other: Scuba diving activities Other: Virtual reality activities Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : February 7, 2023
Actual Primary Completion Date : September 27, 2023
Actual Study Completion Date : October 20, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The main objective is to study the physiological effects of pressure regulator immersion [ Time Frame: 6 months ]
    Measure of parterial pressure

  2. The main objective is to study the physiological effects of regulator ventilation on the activation of the parasympathetic autonomic nervous system [ Time Frame: 6 months ]
    Measure of O2 saturation


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343924


Locations
Layout table for location information
France
CHU de Nice
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Layout table for investigator information
Principal Investigator: Carl WILLEM Centre Hospitalier Universitaire de Nice
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04343924    
Other Study ID Numbers: 19-PP-12
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: January 12, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders