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

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

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

Study Overview

• Status: Completed
• Conditions: Ptsd
• Intervention / Treatment: Behavioral: sport practice

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Not In US/Canada
    • Brétigny-sur-Orge, Not In US/Canada, France, 91223
      • Marion Trousselard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ptsd

Exclusion Criteria:

• mindfulness practice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	four times (baseline, after the course, 1month after the course and 3months after the course)	changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline
heart rate variability on morning	four times (baseline, after the course, one month after the course and 3 months after the course)	changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline

Collaborators and Investigators

• Sponsor: Marion Trousselard

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): February 26, 2019

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2017-002436-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No