Stress Disorder, CombatcognidiveNCT03995992
Benefits of Diving Training on Recovery for Veterans Suffering of Chronic PTSD: an Exploratory Study
A study testing sport in people with Stress Disorder, Combat, run by Institut de Recherche Biomedicale des Armees at 2 sites in France.
Trial summary
Patients suffering from Chronic Posttraumatic Stress Disorder (PTSD) have difficulties in executive cognition that hinder their quality of life and make it difficult to recovery and to reintegrate them socially and professionally. These difficulties are particularly important for soldiers suffering from chronic PTSD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress Disorder, Combat
- What is being tested?
- sport
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Feb 2020to 30 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- veterans
- having a chronic PTSD evaluated by a psychiatrist All soldiers included in this study were on sick leave for at least 6 months due to chronic PTSD and were waiting for a military invalidity committee pension. They were all engaged in the first step of the Omega project and had a nine-day HRT training session planned
Who cannot join
- the psychiatrist did not consider the clinical state appropriate enough to take part in the omega project
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Marion
Brétigny-sur-Orge, Not in US/Canada, 91223
Lionel Gibert, +33637391518, elgib@free.fr
- Recruiting
anne-sophie Pellen
Paris, Not in US/Canada, 75005
Marion Trousselard, 603771727, marion.trousselard@gmail.com
About this study
Official title: Evaluation of the Impact of Diving Training on Recovery in a Cohort of Veterans Suffering of PTSD: an Exploratory Clinical Control Trial
Patients suffering from Chronic Posttraumatic Stress Disorder (PTSD) have difficulties in executive cognition that hinder their quality of life and make it difficult to recovery and to reintegrate them socially and professionally. These difficulties are particularly important for soldiers suffering from chronic PTSD.
The literature suggests that diving may be a complementary approach to improving cognition, in addition to its benefits on the quality of life of patients with chronic PTSD. It appears to be an intervention of interest to improve the successful recovery for veterans with PTSD compared to a multi-sport practice.
Read the detailed description
A French military rehabilitation program proposes the broadening of the relationships between recovery and reintegration by incorporating approaches in the field of positive psychology for soldiers with chronic PTSD. This program was organized for a group of 10 veterans for 10 days. Each morning, from 9 am to 12 pm, participants had sporting activities: mountain walking, mountain biking, climbing, canyoning and collective orienteering running. From 3 pm, they had individual and collective practical workshops based on PTSD psychoeducation, human resources competences and coaching, including a curriculum vitae workshop.
The investigators aims to compare this program included multisport practice with the same praogram included diving instead of multi-sport to evaluate the impact to recovery at one year
- Conditions
- Stress Disorder, Combat
- Being tested
- sport
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sportBehavioural
10 days of sport (diving or multisport), once training per day
| Study group | Role | What they receive |
|---|---|---|
| multi sport | Active comparator | During 10 days, each morning, from 9 am to 12 pm, participants had sporting activities: mountain walking, mountain biking, climbing, canyoning and collective orienteering running. From 3 pm, they had individual and collective practical workshops based on PTSD psychoeducation, human resources competences and coaching, including a curriculum vitae workshop. During their free time, they could take part in collective activities like table football, pool, party games or have a rest. Relaxation exercises were proposed every day after the sporting activity and before dinner. Receives: Behavioral: sport |
| diving | Experimental | During 10 days, each morning, from 9 am to 12 pm, participants had diving activities. From 3 pm, they had individual and collective practical workshops based on PTSD psychoeducation, human resources competences and coaching, including a curriculum vitae workshop. During their free time, they could take part in collective activities like table football, pool, party games or have a rest. Relaxation exercises were proposed every day after the sporting activity and before dinner. Receives: Behavioral: sport |
What is being measured
The primary outcome is the main question the study is designed to answer.
status of professional reinsertion (having a job or not)
Rate of professional reinsertion
Measured: one year after the intervention (sport training)
Secondary outcomes (2)
PTSD symptoms
self-report scale: the post-traumatic checklist 5 (PCL5) threshold=33
Measured: two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
cognitive symptoms
self report scale: the Montreal Cognive Assessment (MOCA) threshold=27
Measured: two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start8 Feb 2020
- Primary completion28 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorder, CombatStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two groups whih differ by the type of sport training: multisport versus diving
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche Biomedicale des Armees
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- marion trousselard, Principal investigator, Institut de Recherche Biomedicale des Armees
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995992
- Sponsor's protocol ID
- IRBA
- Acronym
- cognidive
- Status last verified
- Aug 2022
- First submitted
- 18 May 2019
- Last updated
- 5 Aug 2022
- 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 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Diving Training on Recovery in a Cohort of Veterans Suffering of PTSD: an Exploratory Clinical Control Trial
- ClinicalTrials.gov ID
- NCT03995992
- Acronym / sponsor ID
- cognidive / IRBA
- Conditions
- Stress Disorder, Combat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institut de Recherche Biomedicale des ArmeesOther government
- Study start
- 8 Feb 2020 (actual)
- Primary completion
- 28 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 24 Jun 2019 (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.
Patients suffering from Chronic Posttraumatic Stress Disorder (PTSD) have difficulties in executive cognition that hinder their quality of life and make it difficult to recovery and to reintegrate them socially and professionally. These difficulties are particularly important for soldiers suffering from chronic PTSD.
The literature suggests that diving may be a complementary approach to improving cognition, in addition to its benefits on the quality of life of patients with chronic PTSD. It appears to be an intervention of interest to improve the successful recovery for veterans with PTSD compared to a multi-sport practice.
Detailed description
A French military rehabilitation program proposes the broadening of the relationships between recovery and reintegration by incorporating approaches in the field of positive psychology for soldiers with chronic PTSD. This program was organized for a group of 10 veterans for 10 days. Each morning, from 9 am to 12 pm, participants had sporting activities: mountain walking, mountain biking, climbing, canyoning and collective orienteering running. From 3 pm, they had individual and collective practical workshops based on PTSD psychoeducation, human resources competences and coaching, including a curriculum vitae workshop.
The investigators aims to compare this program included multisport practice with the same praogram included diving instead of multi-sport to evaluate the impact to recovery at one year
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups whih differ by the type of sport training: multisport versus diving
| Arm | Type | Receives |
|---|---|---|
| multi sport | Active comparator | Behavioral: sportDuring 10 days, each morning, from 9 am to 12 pm, participants had sporting activities: mountain walking, mountain biking, climbing, canyoning and collective orienteering running. From 3 pm, they had individual and collective practical workshops based on PTSD psychoeducation, human resources competences and coaching, including a curriculum vitae workshop. During their free time, they could take part in collective activities like table football, pool, party games or have a rest. Relaxation exercises were proposed every day after the sporting activity and before dinner. |
| diving | Experimental | Behavioral: sportDuring 10 days, each morning, from 9 am to 12 pm, participants had diving activities. From 3 pm, they had individual and collective practical workshops based on PTSD psychoeducation, human resources competences and coaching, including a curriculum vitae workshop. During their free time, they could take part in collective activities like table football, pool, party games or have a rest. Relaxation exercises were proposed every day after the sporting activity and before dinner. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- veterans
- having a chronic PTSD evaluated by a psychiatrist All soldiers included in this study were on sick leave for at least 6 months due to chronic PTSD and were waiting for a military invalidity committee pension. They were all engaged in the first step of the Omega project and had a nine-day HRT training session planned
Key exclusion criteria (1 listed)
- the psychiatrist did not consider the clinical state appropriate enough to take part in the omega project
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 |
|---|---|---|
| sport10 days of sport (diving or multisport), once training per day | Behavioural | diving, multi sport |
Primary outcome
status of professional reinsertion (having a job or not)
Time frame: one year after the intervention (sport training)
Rate of professional reinsertion
2 secondary outcomes
PTSD symptoms
Time frame: two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
cognitive symptoms
Time frame: two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- 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.
marion trousselard principal investigator
Institut de Recherche Biomedicale des Armees
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sport in people with Stress Disorder, Combat, run by Institut de Recherche Biomedicale des Armees at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marion Trousselard (+33644066637, marion.trousselard@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
status of professional reinsertion (having a job or not) (time frame: one year after the intervention (sport training)). 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 5 Aug 2022.