Benefits of Diving Training on Recovery for Veterans Suffering of Chronic PTSD: an Exploratory Study (cognidive)

August 4, 2022 updated by: Institut de Recherche Biomedicale des Armees

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: lionel Gibert
  • Phone Number: 33637391518
  • Email: elgib@free.fr

Study Locations

  • France
    • Not In US/Canada
      • Brétigny-sur-Orge, Not In US/Canada, France, 91223
        • Recruiting
        • Marion
        • Contact:
      • Paris, Not In US/Canada, France, 75005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: multi sport
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.
Behavioral: sport
10 days of sport (diving or multisport), once training per day
Experimental: diving
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.
Behavioral: sport
10 days of sport (diving or multisport), once training per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
status of professional reinsertion (having a job or not)
Time Frame: one year after the intervention (sport training)
Rate of professional reinsertion
one year after the intervention (sport training)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD symptoms
Time Frame: two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
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)
cognitive symptoms
Time Frame: two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory level
Time Frame: two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
salivary cytokines
two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherche Biomedicale des Armees

Investigators

  • Principal Investigator: marion trousselard, Institut de Recherche Biomédicale des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2020

Primary Completion (Anticipated)

November 28, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

May 18, 2019

First Submitted That Met QC Criteria

June 20, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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