Back to resultsDiving for Post Traumatic Stress Disorder (PTSD) (Dive-Hope)
Primary Purpose
Ptsd
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sport practice
Sponsored by
About this trial
This is an interventional treatment trial for Ptsd
Eligibility Criteria
Inclusion Criteria:
- ptsd
Exclusion Criteria:
- mindfulness practice
Sites / Locations
- Marion Trousselard
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
sport training
diving
Arm Description
training course lasting 10 days. It included 10 days of multisports practice once (2h) per day.
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
Outcomes
Primary Outcome Measures
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)
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.
four times (baseline, after the course, 1month after the course and 3months after the course)
heart rate variability on morning
four times (baseline, after the course, one month after the course and 3 months after the course)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03332290
Brief Title
Diving for Post Traumatic Stress Disorder (PTSD)
Acronym
Dive-Hope
Official Title
Post Traumatic Stress Disorder (PTSD): Benefits of Diving Practice on Patient Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
February 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marion Trousselard
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptsd
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized opened clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sport training
Arm Type
Active Comparator
Arm Description
training course lasting 10 days. It included 10 days of multisports practice once (2h) per day.
Arm Title
diving
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
sport practice
Intervention Description
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.
Primary Outcome Measure Information:
Title
quality of life (Mental Health Continuum-Short Form (MHC-SF))
Description
four times (baseline, after the course, 1month after the course and 3months after the course)
Time Frame
changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline)
Secondary Outcome Measure Information:
Title
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.
Description
four times (baseline, after the course, 1month after the course and 3months after the course)
Time Frame
changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline
Title
heart rate variability on morning
Description
four times (baseline, after the course, one month after the course and 3 months after the course)
Time Frame
changes from baseline (after the course minus baseline), (1month after the course minus baseline) and (3months after the course minus baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ptsd
Exclusion Criteria:
mindfulness practice
Facility Information:
Facility Name
Marion Trousselard
City
Brétigny-sur-Orge
State/Province
Not In US/Canada
ZIP/Postal Code
91223
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Diving for Post Traumatic Stress Disorder (PTSD)
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