NCT03332290

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2019

Completed
Last Updated

February 27, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

October 25, 2017

Last Update Submit

February 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (2)

sport training

ACTIVE COMPARATOR

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

Behavioral: sport practice

diving

EXPERIMENTAL

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

Interventions

sport practiceBEHAVIORAL

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.

divingsport training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ptsd

You may not qualify if:

  • mindfulness practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marion Trousselard

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

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized opened clinical trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 6, 2017

Study Start

October 10, 2017

Primary Completion

December 30, 2017

Study Completion

February 26, 2019

Last Updated

February 27, 2019

Record last verified: 2019-01

Locations