Dive-Hope: Diving for Post Traumatic Stress Disorder (PTSD)

Sponsor

Marion Trousselard (Other)

Overall Status

Completed

CT.gov ID

NCT03332290

Collaborator

(none)

Enrollment

Location

Arms

16.6

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

within the components of Scuba diving there are similarities with meditation and mindfulness techniques. PTSD and emotion dysregulation are known to be involved by meditation training This study evaluates the benefits of scuba diving on quality of life and mindful functioning comparing the benefits of diving training using a clinical trial protocol

Condition or Disease	Intervention/Treatment	Phase
Ptsd	Behavioral: sport practice	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized opened clinical trialrandomized opened clinical trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Post Traumatic Stress Disorder (PTSD): Benefits of Diving Practice on Patient Quality of Life

Actual Study Start Date :

Oct 10, 2017

Actual Primary Completion Date :

Dec 30, 2017

Actual Study Completion Date :

Feb 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: sport training training course lasting 10 days. It included 10 days of multisports practice once (2h) per day.	Behavioral: sport practice the intervention was a training course lasting 10 days. It included 10 days of sports practice. For divers, diving was carried out using air at a maximum depth of 40-meters, with a maximum of one dives a day. For the multisport group (the non-divers), the course included kayaking, mountain climbing or hiking with a maximum of two activities a day.
Experimental: diving diving course lasting 10 days. It included 10 days of diving once (2h) per day. Diving will be carried out using air at a maximum depth of 30-meters	Behavioral: sport practice the intervention was a training course lasting 10 days. It included 10 days of sports practice. For divers, diving was carried out using air at a maximum depth of 40-meters, with a maximum of one dives a day. For the multisport group (the non-divers), the course included kayaking, mountain climbing or hiking with a maximum of two activities a day.

Arm

Intervention/Treatment

Active Comparator: sport training

training course lasting 10 days. It included 10 days of multisports practice once (2h) per day.

Behavioral: sport practice

the intervention was a training course lasting 10 days. It included 10 days of sports practice. For divers, diving was carried out using air at a maximum depth of 40-meters, with a maximum of one dives a day. For the multisport group (the non-divers), the course included kayaking, mountain climbing or hiking with a maximum of two activities a day.

Experimental: diving

diving course lasting 10 days. It included 10 days of diving once (2h) per day. Diving will be carried out using air at a maximum depth of 30-meters

Behavioral: sport practice

Outcome Measures

Primary Outcome Measures

quality of life (Mental Health Continuum-Short Form (MHC-SF)) [changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline)]
four times (baseline, after the course, 1month after the course and 3months after the course)

Secondary Outcome Measures

post-traumatic checklist scale; a 20-item self-report scale assessing the 20 DSM-5 symptoms of PTSD with a symptom severity from 0 to 80 and a cut-point score of 33. [changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline]
four times (baseline, after the course, 1month after the course and 3months after the course)
heart rate variability on morning [changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline]
four times (baseline, after the course, one month after the course and 3 months after the course)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ptsd

Exclusion Criteria:

mindfulness practice

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marion Trousselard	Brétigny-sur-Orge	Not In US/Canada	France	91223

Sponsors and Collaborators

Marion Trousselard

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marion Trousselard, principal investigator, Institut de Recherche Biomedicale des Armees

ClinicalTrials.gov Identifier:

NCT03332290

Other Study ID Numbers:

2017-002436-16

First Posted:

Nov 6, 2017

Last Update Posted:

Feb 27, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Feb 27, 2019