NCT03936738

Brief Summary

The aim of this study is to identify if an avalanche accident has a psychological impact on avalanche victims. The investigators hypothesize that being exposed to an avalanche could generate enough stress to develop posttraumatic stress symptoms or even more, an authentic posttraumatic stress disorder (PTSD). Additionally, the investigators think that such symptoms might lead to physical and psychological distress in daily life. Lastly, the investigators suppose that a serious traumatism, a complete and/or prolonged burial, the death of a family member or a closed friend could be a potential risk factors to develop PTSD symptoms in avalanche victims. To evaluate post traumatic stress symptoms and the quality of life of avalanche survivors, the investigators use the Impact of Event Scale - Revised and the Short Form 12. These two scales are included in a standardized questionnaire, which is submitted to avalanche victims during a phone call.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 18, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

April 18, 2019

Last Update Submit

February 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prospective evaluation of the prevalence of Posttraumatic Stress Disorder of the avalanche survivors included in the RENAAV from December 2014 to May 2018.

    The primary outcome is the total score obtained to the Impact of Event Scale Revised (IES-R). This score is validated, translated in french, easy and fast to achieve during a phone call. It is a 22 questions scale which explore the three categories of posttraumatic stress symptoms : intrusion, avoidance, and hyperarousal. Total score ranges between 0 and 88. Results will be separated into three categories : 1) score higher than or equal to 33 ; 2) score between 12 to 32 ; and 3) score lower than or equal to 11. We choose a cut-off score of 33 as seen in the literature. Above 33, the diagnostic of posttraumatic stress disorder must be confirmed with a psychiatric analysis (sensibility = 91 %, specificity = 87 %).

    Data will be gathered by phone from May to June 2019, all interviews will be conducted in the same place by the same person. Subjects will be randomly contacted.

Secondary Outcomes (3)

  • Evaluation of the quality of life, physical and psychological health of an avalanche survivor included in the RENAAV.

    Data will be gathered by phone from May to June 2019, all interviews will be conducted in the same place by the same person. Subjects will be randomly contacted.

  • Analysis of risk factors associated with the onset of Post Traumatic Stress disorder (PTSD) symptoms.

    Data will be gathered by phone from May to June 2019, all interviews will be conducted in the same place by the same person. Subjects will be randomly contacted.

  • Research of mountain practice changing.

    Data will be gathered by phone from May to June 2019, all interviews will be conducted in the same place by the same person. Subjects will be randomly contacted.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects exposed to an avalanche in the French North Alps and included in the North Alpine Avalanche Register (RENAAV) from the 1st of December 2014 to the 31th of May 2018.

You may qualify if:

  • Adults men and women involved in an avalanche in the French North Alps from the 1rs of December 2014 to 31th of May 2018
  • Non opposed during the phone call

You may not qualify if:

  • Age \< 18, when the avalanche occurred
  • Non French speaking persons
  • Victims deprived of their liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (6)

  • Breslau N. The epidemiology of trauma, PTSD, and other posttrauma disorders. Trauma Violence Abuse. 2009 Jul;10(3):198-210. doi: 10.1177/1524838009334448. Epub 2009 Apr 30.

  • Thordardottir EB, Valdimarsdottir UA, Hansdottir I, Resnick H, Shipherd JC, Gudmundsdottir B. Posttraumatic stress and other health consequences of catastrophic avalanches: A 16-year follow-up of survivors. J Anxiety Disord. 2015 May;32:103-11. doi: 10.1016/j.janxdis.2015.03.005. Epub 2015 Mar 28.

  • Parry-Jones B, Parry-Jones WL. Post-traumatic stress disorder: supportive evidence from an eighteenth century natural disaster. Psychol Med. 1994 Feb;24(1):15-27. doi: 10.1017/s0033291700026799.

  • Johnsen BH, Eid J, Lovstad T, Michelsen LT. Posttraumatic stress symptoms in nonexposed, victims, and spontaneous rescuers after an avalanche. J Trauma Stress. 1997 Jan;10(1):133-40. doi: 10.1023/a:1024820716613.

  • Finnsdottir T, Elklit A. Posttraumatic sequelae in a community hit by an avalanche. J Trauma Stress. 2002 Dec;15(6):479-85. doi: 10.1023/A:1020969906251.

  • Leonard C, Charriau-Perret A, Debaty G, Belle L, Ricard C, Sanchez C, Dupre PM, Panoff G, Bougerol T, Viglino D, Blancher M; Northern French-Alps Emergency Network ("RENAU"). Survivors of avalanche accidents: posttraumatic stress disorder symptoms and quality of life: a multicentre study. Scand J Trauma Resusc Emerg Med. 2021 Jul 19;29(1):96. doi: 10.1186/s13049-021-00912-3.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

May 3, 2019

Study Start

May 1, 2019

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Locations