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

Primary Purpose

Post-traumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scuba diving activities
Virtual reality activities
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Diving Group

    Virtual reality Group

    Control Group

    Arm Description

    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.

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

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

    Outcomes

    Primary Outcome Measures

    The main objective is to study the physiological effects of pressure regulator immersion
    Measure of parterial pressure
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 3, 2020
    Last Updated
    April 13, 2020
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04343924
    Brief Title
    Clinical Study About the Effects of Scuba Diving on Post Traumatic Stress Disorder (PTSD)
    Acronym
    DIVE4NICE
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2020 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-traumatic Stress Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Diving Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Virtual reality Group
    Arm Type
    Active Comparator
    Arm Description
    The subjects of this group will follow virtual reality sessions recreating the environment in which the submarine diver of the GP+ group operates.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    The subjects of this group will be monitored and treated for PTSD and will not attend the dive discovery course or virtual reality sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Scuba diving activities
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Virtual reality activities
    Intervention Description
    The subjects of this group will follow virtual reality sessions recreating the environment in which the submarine diver of the GP+ group operates
    Primary Outcome Measure Information:
    Title
    The main objective is to study the physiological effects of pressure regulator immersion
    Description
    Measure of parterial pressure
    Time Frame
    6 months
    Title
    The main objective is to study the physiological effects of regulator ventilation on the activation of the parasympathetic autonomic nervous system
    Description
    Measure of O2 saturation
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marion Causeret
    Phone
    00033492034702
    Email
    causeret.m@chu-nice.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vanina Oliveri
    Phone
    00033492034254
    Email
    oliveri.v@chu-nice.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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