The primary objective of this study is to derive and externally validate a prognostic screening instrument to predict individual risk to follow an adverse PTSD symptom trajectory over the course of one year following trauma based on self-report…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the Area under the Receiver Operator Characteristic
curve (AUC) of the derived machine learning algorithms, reflecting the accuracy
in correctly classifying participants in the respective test sets into the
adverse latent PTSD symptom trajectories. These adverse latent PTSD symptom
trajectories are determined from the PTSD symptom severity measured across
assessments (TraumaTIPS: CAPS total score, 2-ASAP: PCL5 total score). The
machine learning algorithms are based on information collected from self-report
questionnaires at the baseline assessments, relating to demographic
characteristics, details on current and previous trauma exposure and related
emotions, cognitions and social support and current and immediate past
psychological and physical health symptoms.
Secondary outcome
The baseline assessment additional includes current best-practice screening
instruments for PTSD (secondary outcomes). The follow-up assessments
additionally includes self-report questionnaires on co-morbid psychological
symptoms and functional and economic outcomes (secondary outcomes).
Background summary
Upon exposure to traumatic events involving (threatened) death, injury or
violated physical integrity, a substantial minority of individuals subsequently
develops the psychiatric disorder posttraumatic stress disorder (PTSD). There
are increasing indications for sex differences in PTSD*s symptom course and
underlying etiological mechanisms.
Only the first weeks post-trauma provide a unique window of opportunity for
preventive interventions. Such preventive interventions can decrease PTSD
prevalence and relatedly improve wellbeing, functioning, quality of life, and
reduce health care use, productive loss and associated costs. Importantly,
while there are several promising preventive interventions, it has now become
clear that preventive interventions are only feasible and effective if
delivered as indicated preventive intervention to individuals at high risk for
PTSD. There are currently no prognostic screening instruments accurately
classifying individuals* risk for an adverse PTSD symptom course that can be
administered to a broad population of acutely trauma-exposed individuals within
the first weeks thereafter.
Study objective
The primary objective of this study is to derive and externally validate a
prognostic screening instrument to predict individual risk to follow an adverse
PTSD symptom trajectory over the course of one year following trauma based on
self-report information on previously identified PTSD risk and protective
factors collected early post-trauma using sex-disaggregated machine learning
algorithms. Secondary objectives are to investigate potential novel PTSD risk
and protective factors and update the prognostic screening instrument;
differences in co-morbid psychological symptoms; functional and economic
outcomes between individuals classified as low versus high risk; and to compare
the accuracy of the derived prognostic screening instrument with current best
practice screening instruments for PTSD.
Study design
The study uses both existing and newly to be collected observational
prospective cohort data. Both cohorts include a first baseline assessment
within the first weeks post-trauma and include 4 follow-up assessments until
one year posttrauma.
Study burden and risks
For the new cohort, all data is derived from online self-report questionnaires.
There will be no direct benefits for the subjects to participate in the study.
The assessment of the potential risk relating to the participant*s safety and
wellbeing is somewhat higher than that of standard medical care/normal daily
life, due to the potential disquieting nature of the questionnaires. The final
risk classification is negligible.
Meibergdreef 5
Amsterdam 1105 AZ
NL
Meibergdreef 5
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this cohort, a participant must meet
all of the following criteria:
- Age 18 years or older;
- Experience of an traumatic event according to DSM-5 PTSD A criterion (i.e.
involving actual or threatened death, violence or violation of physical
integrity) maximally 60 days posttrauma at baseline.
- The traumatic events need to be directly experienced by the participant
themselves, have an acute onset, external cause and the potential to lead to
serious physical injury (i.e. not a medical condition).
Exclusion criteria
A potential participant who meets any of the following criteria will be
excluded from participation:
- Evidence of homicidality, suicidality, injuries due to intentional
self-inflicted injury;
- Evidence of ongoing or repeated trauma exposure, such as ongoing domestic
violence;
- Evidence of an inability to understand study procedures, risks or being
otherwise unable to give informed consent;
- Evidence of being unable to follow protocol (due to any reason, including
visual or cognitive or physical impairment precluding completion of protocol);
- Impairment in ability to use or no regular access to internet-connected
smartphone, tablet or computer for completion of online assessments;
Insufficient understanding of Dutch language to follow protocol
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80296.018.22 |