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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03995992
Other study ID # IRBA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 8, 2020
Est. completion date December 30, 2022

Study information

Verified date August 2022
Source Institut de Recherche Biomedicale des Armees
Contact Marion Trousselard
Phone +33644066637
Email marion.trousselard@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 30, 2022
Est. primary completion date November 28, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - the psychiatrist did not consider the clinical state appropriate enough to take part in the omega project

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
sport
10 days of sport (diving or multisport), once training per day

Locations

Country Name City State
France Marion Brétigny-sur-Orge Not In US/Canada
France anne-sophie Pellen Paris Not In US/Canada

Sponsors (1)

Lead Sponsor Collaborator
Institut de Recherche Biomedicale des Armees

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other inflammatory level salivary cytokines two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
Primary status of professional reinsertion (having a job or not) Rate of professional reinsertion one year after the intervention (sport training)
Secondary PTSD symptoms self-report scale: the post-traumatic checklist 5 (PCL5) threshold=33 two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
Secondary cognitive symptoms self report scale: the Montreal Cognive Assessment (MOCA) threshold=27 two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)