NCT03995992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

February 8, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

2.8 years

First QC Date

May 18, 2019

Last Update Submit

August 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Rate of professional reinsertion

    one year after the intervention (sport training)

Secondary Outcomes (2)

  • PTSD symptoms

    two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)

  • cognitive symptoms

    two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)

Other Outcomes (1)

  • inflammatory level

    two times points ; change were assessed between before and after the sport training (eg. before and 10 days after)

Study Arms (2)

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.

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.

Behavioral: sport

Interventions

sportBEHAVIORAL

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

divingmulti sport

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • the psychiatrist did not consider the clinical state appropriate enough to take part in the omega project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Marion

Brétigny-sur-Orge, Not in US/Canada, 91223, France

RECRUITING

anne-sophie Pellen

Paris, Not in US/Canada, 75005, France

RECRUITING

MeSH Terms

Conditions

Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • marion trousselard

    Institut de Recherche Biomedicale des Armees

    PRINCIPAL INVESTIGATOR

Central Study Contacts

lionel Gibert

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two groups whih differ by the type of sport training: multisport versus diving
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2019

First Posted

June 24, 2019

Study Start

February 8, 2020

Primary Completion

November 28, 2022

Study Completion

December 30, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations