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

Primary Purpose

Stress Disorder, Combat

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sport
Sponsored by
Institut de Recherche Biomedicale des Armees
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress Disorder, Combat

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MarionRecruiting
  • anne-sophie PellenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

multi sport

diving

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

status of professional reinsertion (having a job or not)
Rate of professional reinsertion

Secondary Outcome Measures

PTSD symptoms
self-report scale: the post-traumatic checklist 5 (PCL5) threshold=33
cognitive symptoms
self report scale: the Montreal Cognive Assessment (MOCA) threshold=27

Full Information

First Posted
May 18, 2019
Last Updated
August 4, 2022
Sponsor
Institut de Recherche Biomedicale des Armees
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1. Study Identification

Unique Protocol Identification Number
NCT03995992
Brief Title
Benefits of Diving Training on Recovery for Veterans Suffering of Chronic PTSD: an Exploratory Study
Acronym
cognidive
Official Title
Evaluation of the Impact of Diving Training on Recovery in a Cohort of Veterans Suffering of PTSD: an Exploratory Clinical Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2020 (Actual)
Primary Completion Date
November 28, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherche Biomedicale des Armees

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorder, Combat

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups whih differ by the type of sport training: multisport versus diving
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
multi sport
Arm Type
Active Comparator
Arm Description
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.
Arm Title
diving
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
sport
Intervention Description
10 days of sport (diving or multisport), once training per day
Primary Outcome Measure Information:
Title
status of professional reinsertion (having a job or not)
Description
Rate of professional reinsertion
Time Frame
one year after the intervention (sport training)
Secondary Outcome Measure Information:
Title
PTSD symptoms
Description
self-report scale: the post-traumatic checklist 5 (PCL5) threshold=33
Time Frame
two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
Title
cognitive symptoms
Description
self report scale: the Montreal Cognive Assessment (MOCA) threshold=27
Time Frame
two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)
Other Pre-specified Outcome Measures:
Title
inflammatory level
Description
salivary cytokines
Time Frame
two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Trousselard
Phone
+33644066637
Email
marion.trousselard@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
lionel Gibert
Phone
33637391518
Email
elgib@free.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marion trousselard
Organizational Affiliation
Institut de Recherche Biomedicale des Armees
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marion
City
Brétigny-sur-Orge
State/Province
Not In US/Canada
ZIP/Postal Code
91223
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Gibert
Phone
+33637391518
Email
elgib@free.fr
Facility Name
anne-sophie Pellen
City
Paris
State/Province
Not In US/Canada
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Trousselard
Phone
603771727
Email
marion.trousselard@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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