Clinical trial NCT03936738: Posttraumatic Stress Disorder and Quality of Life of Avalanche Survivors From 2014 to 2018, Based on the French North Alpine Avalanche Register
Official title: Posttraumatic Stress Disorder and Quality of Life of Avalanche Survivors From 2014 to 2018, Based on the French North Alpine Avalanche Register: Risk Factor Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Traumatic Stress Disorder
Avalanche, Landslide, or Mudslide
Quality of Life
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: It is already known that a traumatism, whatever nature or gravity, could lead to acute stress symptoms and a posttraumatic stress disorder (PTSD) one month after (1). In the last decades, less than ten studies showed that avalanche survivors are likely to develop PTSD, even sixteen years after exposure (2, 3). In those studies, authors focused on natural disaster avalanches (on habitations or roads). This study would like to evaluate psychological impact of an avalanche accident occurring during mountain recreational activities.

The primary outcome concerns the research of PTSD symptoms using the Impact of Event Scale - Revised (IES-R). It is a 22 items scale, which explores specifics symptoms of Post Traumatic Stress Disorder that may have occurred during the week before the interview. It concerns 3 different possible areas of PTSD: intrusion (eight items), avoidance (eight items) and hyperarousal symptoms (six items). Each item ranges from 0 (not at all) to 4 (extremely). The total score of the IES-R ranges between 0 and 88. A score equal or more than 33 is highly in favour of PTSD (91% sensitivity, 82% specificity, 90% positive predictive value and 84% negative predictive value). However, above 33 the diagnostic of posttraumatic stress disorder must be confirmed by a psychiatric analysis. Our results will be separated in two categories for the analysis: 1) IES-R score higher or equal to 33; 2) IES-R score lower than 33.

The secondary outcome is the result of the Short Form 12 questionnaire (SF-12). The SF-12 consists of 12 items selected from the "Medical Outcomes Study 36-items Short-Form Health Survey" (SF-36) to reproduce the Physical Component Summary and Mental Component Summary scales in the general US population. The SF-12 Health Survey was developed in the United States to provide a shorter alternative to the SF-36. The SF-12 contains a subset of 12 items from the SF-36, including one or two items from each of the eight SF-36 scales (general health, physical role, physical bodily, vitality, social and emotional functioning, role emotional and mental health). SF-12 Physical and Mental Components are scored from 0 to 100. A higher score indicates a better health state. Scores will be compared to literature data.

Study population concerns avalanche survivors in the French Northern Alps during the last four years. Furthermore, the investigators will try to identify risk factors to develop PTSD in these circumstances. They will try to know if survivors have changed their mountain practice after the accident. From 2014 to 2018, there were 211 avalanche victims in the French North Alps included in the North Alpine Avalanche Register (RENAAV), 132 victims survived. Considering the rate of non-response, the investigators are expecting between 50 to 80 subjects to be analysed. Data will be collected in the medical records and during a phone interview with a standardized questionnaire. A rate of 9,2 % of posttraumatic stress symptoms is expected, corresponding to the prevalence of PTSD (1) after traumatism.

Concerning statistical analysis, quantitative data will be described in terms of mean, standard deviation, median and extreme values. Qualitative data will be described in terms of absolute frequency and percentage by modality. The 95% confidence intervals will be presented. Quantitative data will be compared by a Student's parametric test, replaced by the Wilcoxon test in case of deviation from the normality of distribution. Categorical data will be compared by a Chi 2 test or Fischer's exact test in case of too small sample. A threshold of significance will be retained for a value of p \< 0.05. Univariate and multivariate analyses will be performed to independently identify risk factors at a higher frequency of PTSD.

The research team received the approval of ethical research committees since the March 19th of 2019.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Prospective evaluation of the prevalence of Posttraumatic Stress Disorder of the avalanche survivors included in the RENAAV from December 2014 to May 2018.
timeFrame: 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:
measure: Evaluation of the quality of life, physical and psychological health of an avalanche survivor included in the RENAAV.
timeFrame: 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.
measure: Analysis of risk factors associated with the onset of Post Traumatic Stress disorder (PTSD) symptoms.
timeFrame: 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.
measure: Research of mountain practice changing.
timeFrame: 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.
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.