Post-traumatic Stress DisorderDIVE4NICENCT04343924
Clinical Study About the Effects of Scuba Diving on Post Traumatic Stress Disorder (PTSD)
A study testing Scuba diving activities and Virtual reality activities in people with Post-traumatic Stress Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Scuba diving activities and Virtual reality activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2023to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- PCL-S score strictly greater than 44
- CGI greater than or equal to 4
- Chronicity (duration greater than 3 months)
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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
- Being tested
- Scuba diving activities, Virtual reality activities
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scuba diving activitiesOther
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.
Virtual reality activitiesOther
The subjects of this group will follow virtual reality sessions recreating the environment in which the submarine diver of the GP+ group operates
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to study the physiological effects of pressure regulator immersion
Measure of parterial pressure
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start7 Feb 2023
- Primary completion27 Sep 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl WILLEM, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343924
- Sponsor's protocol ID
- 19-PP-12
- Acronym
- DIVE4NICE
- Status last verified
- Jan 2024
- First submitted
- 3 Apr 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04343924
- Acronym / sponsor ID
- DIVE4NICE / 19-PP-12
- Conditions
- Post-traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diving Group | Experimental | Other: Scuba diving activitiesThe 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. |
| Virtual reality Group | Active comparator | Other: Virtual reality activitiesThe subjects of this group will follow virtual reality sessions recreating the environment in which the submarine diver of the GP+ group operates. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scuba diving activitiesThe 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 | Diving Group |
| Virtual reality activitiesThe 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 Group |
Primary outcome
The main objective is to study the physiological effects of pressure regulator immersion
Time frame: 6 months
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
Time frame: 6 months
Measure of O2 saturation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl WILLEM principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scuba diving activities and Virtual reality activities in people with Post-traumatic Stress Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main objective is to study the physiological effects of pressure regulator immersion (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.