PtsdDive-HopeNCT03332290
Diving for Post Traumatic Stress Disorder (PTSD)
A study testing sport practice in people with Ptsd, run by Marion Trousselard at 1 site in France.
Trial summary
within the components of Scuba diving there are similarities with meditation and mindfulness techniques. PTSD and emotion dysregulation are known to be involved by meditation training This study evaluates the benefits of scuba diving on quality of life and mindful functioning comparing the benefits of diving training… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ptsd
- What is being tested?
- sport practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2017to 26 Feb 2019
- 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
- ptsd
Who cannot join
- mindfulness practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Traumatic Stress Disorder (PTSD): Benefits of Diving Practice on Patient Quality of Life
within the components of Scuba diving there are similarities with meditation and mindfulness techniques. PTSD and emotion dysregulation are known to be involved by meditation training This study evaluates the benefits of scuba diving on quality of life and mindful functioning comparing the benefits of diving training using a clinical trial protocol
- Conditions
- Ptsd
- Being tested
- sport practice
- 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.
sport practiceBehavioural
the intervention was a training course lasting 10 days. It included 10 days of sports practice. For divers, diving was carried out using air at a maximum depth of 40-meters, with a maximum of one dives a day. For the multisport group (the non-divers), the course included kayaking, mountain climbing or hiking with a maximum of two activities a day.
| Study group | Role | What they receive |
|---|---|---|
| sport training | Active comparator | training course lasting 10 days. It included 10 days of multisports practice once (2h) per day. Receives: Behavioral: sport practice |
| diving | Experimental | diving course lasting 10 days. It included 10 days of diving once (2h) per day. Diving will be carried out using air at a maximum depth of 30-meters Receives: Behavioral: sport practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life (Mental Health Continuum-Short Form (MHC-SF))
four times (baseline, after the course, 1month after the course and 3months after the course)
Measured: changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline)
Secondary outcomes (2)
post-traumatic checklist scale; a 20-item self-report scale assessing the 20 DSM-5 symptoms of PTSD with a symptom severity from 0 to 80 and a cut-point score of 33.
four times (baseline, after the course, 1month after the course and 3months after the course)
Measured: changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline
heart rate variability on morning
four times (baseline, after the course, one month after the course and 3 months after the course)
Measured: changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start10 Oct 2017
- Primary completion30 Dec 2017
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PtsdStudies of the same condition, open and under way.
- 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
- Model description
- randomized opened clinical trial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marion Trousselard
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Marion Trousselard, Institut de Recherche Biomedicale des Armees
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332290
- Sponsor's protocol ID
- 2017-002436-16
- Other IDs
- 2017
- Acronym
- Dive-Hope
- Status last verified
- Jan 2019
- First submitted
- 25 Oct 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Traumatic Stress Disorder (PTSD): Benefits of Diving Practice on Patient Quality of Life
- ClinicalTrials.gov ID
- NCT03332290
- Acronym / sponsor ID
- Dive-Hope / 2017-002436-16
- Conditions
- Ptsd
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Marion TrousselardOther government
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 6 Nov 2017 (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.
within the components of Scuba diving there are similarities with meditation and mindfulness techniques. PTSD and emotion dysregulation are known to be involved by meditation training This study evaluates the benefits of scuba diving on quality of life and mindful functioning comparing the benefits of diving training using a clinical trial protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized opened clinical trial
| Arm | Type | Receives |
|---|---|---|
| sport training | Active comparator | Behavioral: sport practicetraining course lasting 10 days. It included 10 days of multisports practice once (2h) per day. |
| diving | Experimental | Behavioral: sport practicediving course lasting 10 days. It included 10 days of diving once (2h) per day. Diving will be carried out using air at a maximum depth of 30-meters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ptsd
Key exclusion criteria (1 listed)
- mindfulness practice
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 |
|---|---|---|
| sport practicethe intervention was a training course lasting 10 days. It included 10 days of sports practice. For divers, diving was carried out using air at a maximum depth of 40-meters, with a maximum of one dives a day. For the multisport group (the non-divers), the course included kayaking, mountain climbing or hiking with a maximum of two activities a day. | Behavioural | diving, sport training |
Primary outcome
quality of life (Mental Health Continuum-Short Form (MHC-SF))
Time frame: changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline)
four times (baseline, after the course, 1month after the course and 3months after the course)
2 secondary outcomes
post-traumatic checklist scale; a 20-item self-report scale assessing the 20 DSM-5 symptoms of PTSD with a symptom severity from 0 to 80 and a cut-point score of 33.
Time frame: changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline
heart rate variability on morning
Time frame: changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline
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 27 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sport practice in people with Ptsd, run by Marion Trousselard 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 1 inclusion and 1 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 27 Feb 2019. 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?
quality of life (Mental Health Continuum-Short Form (MHC-SF)) (time frame: changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline)). 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 27 Feb 2019; AzTrials last refreshed its copy on 29 Oct 2026.