Towards accurate screening and prevention (2-ASAP): PTSD risk screening study

Recruiting

• Conditions: posttraumatic stress; Posttraumatic stress disorder (PTSD); 10002861

• Registration Number: NL-OMON53786
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 863

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the Area under the Receiver Operator Characteristic<br /><br>curve (AUC) of the derived machine learning algorithms, reflecting the accuracy<br /><br>in correctly classifying participants in the respective test sets into the<br /><br>adverse latent PTSD symptom trajectories. These adverse latent PTSD symptom<br /><br>trajectories are determined from the PTSD symptom severity measured across<br /><br>assessments (TraumaTIPS: CAPS total score, 2-ASAP: PCL5 total score). The<br /><br>machine learning algorithms are based on information collected from self-report<br /><br>questionnaires at the baseline assessments, relating to demographic<br /><br>characteristics, details on current and previous trauma exposure and related<br /><br>emotions, cognitions and social support and current and immediate past<br /><br>psychological and physical health symptoms. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The baseline assessment additional includes current best-practice screening<br /><br>instruments for PTSD (secondary outcomes). The follow-up assessments<br /><br>additionally includes self-report questionnaires on co-morbid psychological<br /><br>symptoms and functional and economic outcomes (secondary outcomes).</p><br>