Post Traumatic Stress DisorderESPTAvalancheNCT03936738
Posttraumatic Stress Disorder and Quality of Life of Avalanche Survivors From 2014 to 2018, Based on the French North Alpine Avalanche Register
An observational study of Post Traumatic Stress Disorder and Avalanche, Landslide, or Mudslide, run by University Hospital, Grenoble at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Avalanche, Landslide, or Mudslide, Quality of Life
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age < 18, when the avalanche occurred
- Non French speaking persons
- Victims deprived of their liberty
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Medical subject headings
- Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %).
Measured: 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.
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.
Measured: 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.
To do this analyse, we form two groups : those who have a Impact of Event Scale Revised (IES-R) score higher than or equal to 33 (PTSD +) ; and those who have a score lower tha 33 (PTSD -).
The following risk factors will be analysed :
- Demographic data : age, sex, family and professional situation
- Severity of physical trauma (calculated with the Injury Severity Scale)
- Cardiac arrest at extraction time
- Complete or partial burial
- Short or prolonged burial
- Death of a person in the accident
- Lost of family member or closed friend
- Length of stay in Intensive care unit
- Medical history of previous traumatism
- Psychiatrical history
- Psychiatric or psychologic care immediately after the accident
- Medical treatment by anti psychotic, and antidepressant drug after the accident
- Mountain activity practiced when the accident occurred
- Outing accompanied by a mountain professional
Measured: 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.
Three questions will be answered concerning mountain practice, at the end of the interview : Do they currently practice the mountain activity they were doing when avalanche occurred ? How long after the accident ? Did they acquired new mountain security geers (such as airbag backpack, avalanche transceiver, snow probe and shovel). The statistical analysis will be descriptive for this section.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 May 2019
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936738
- Sponsor's protocol ID
- 38RC19.033
- Other IDs
- 2018-A02942-53
- Acronym
- ESPTAvalanche
- Status last verified
- Feb 2020
- First submitted
- 18 Apr 2019
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19406860Thordardottir 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.
PubMed 25935315Parry-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.
PubMed 8208880Johnsen 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.
PubMed 9018684Finnsdottir 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.
PubMed 12482187Leonard 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.
PubMed 34281606
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03936738
- Acronym / sponsor ID
- ESPTAvalanche / 38RC19.033
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18, when the avalanche occurred
- Non French speaking persons
- Victims deprived of their liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prospective evaluation of the prevalence of Posttraumatic Stress Disorder of the avalanche survivors included in the RENAAV from December 2014 to May 2018.
Time frame: 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.
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 %).
3 secondary outcomes
Evaluation of the quality of life, physical and psychological health of an avalanche survivor included in the RENAAV.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Results publication: PubMed 19406860Breslau 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.
- Results publication: PubMed 25935315Thordardottir 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.
- Results publication: PubMed 8208880Parry-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.
- Results publication: PubMed 9018684Johnsen 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.
- Results publication: PubMed 12482187Finnsdottir 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.
- Derived from this study: PubMed 34281606Leonard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder and Avalanche, Landslide, or Mudslide, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective evaluation of the prevalence of Posttraumatic Stress Disorder of the avalanche survivors included in the RENAAV from December 2014 to May 2018. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936738, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.