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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03332290
Other study ID # 2017-002436-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2017
Est. completion date February 26, 2019

Study information

Verified date January 2019
Source Institut de Recherche Biomedicale des Armees
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 26, 2019
Est. primary completion date December 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ptsd

Exclusion Criteria:

- mindfulness practice

Study Design


Intervention

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.

Locations

Country Name City State
France Marion Trousselard Brétigny-sur-Orge Not In US/Canada

Sponsors (1)

Lead Sponsor Collaborator
Marion Trousselard

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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