|- candidate number||21715|
|- NTR Number||NTR5065|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-feb-2015|
|- Secondary IDs||NL48552.018.14 AMC METC 2014_300|
|- Public Title||The effectiveness of a mobile app in reducing of post-traumatic stress symptoms
|- Scientific Title||SUPPORT Coach - The Effectiveness of a Mobile Application in Reducing Traumatic Stress|
|- ACRONYM||SUPPORT Coach|
|- hypothesis||We hypothesize that usage of the SUPPORT Coach app will lead to a reduction of post-traumatic stress symptoms directly after usage of the app compared to participants that do not use the app.
Furthermore, we expect that usage of the SUPPORT Coach will decrease negative cognitions about the traumatic event(s) and increase psychological resilience and social support.|
|- Healt Condition(s) or Problem(s) studied||Post-Traumatic Stress Disorder (PTSD), Posttraumatic stress symptoms, Trauma related complaints (e.g. anxiety, depression)|
|- Inclusion criteria||This study is conducted with adults in a high risk profession (e.g., ambulance and emergency department personnel).
1. Age 18 years and older
2. Capable to read and comprehend the Dutch language
Only participants with at least one symptom of post-traumatic stress, objectified by a PC-PTSD-5 score of 1 or higher related to a traumatic event, will be randomized into one of two study conditions.
|- Exclusion criteria||1. No smartphone or tablet|
2. No informed consent
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-jan-2015|
|- planned closingdate||31-dec-2015|
|- Target number of participants||276|
|- Interventions||Participants in the intervention condition will receive unlimited access (during one month) to 'The SUPPORT Coach', a mobile application designed to support individuals with post-traumatic stress symptoms. The app includes information on post-traumatic stress and professional care, exercises and tools to manage traumatic stress symptoms, a self-test to monitor symptoms over time, a seek support section and a calendar function.
Participants in the control group will not receive access to the SUPPORT Coach. Participants in both conditions have access to their own (mental) care if necessary.
|- Primary outcome||The difference in post-traumatic stress symptoms (continuous PCL-5 scores) between the intervention and control condition directly after termination of the intervention period.|
|- Secondary outcome||1. The difference in negative cognitions about the trauma (PTCI) between the intervention and control condititon directly after termination of the intervention period.|
2. The difference in psychological resilience (RES) and perceived social support (SSL-6) between the intervention and control condition directly after termination of the intervention period.
3. User satisfaction with the SUPPORT Coach will be evaluated and user logs will be explored for implementation-information purposes.
|- Timepoints||Primary outcome: PCL-5 scores directly upon termination of the 1-month intervention period|
Secondary outcomes: PTCI, RES, and SSL-6 scores directly upon termination of the 1-month intervention period
A follow-up is scheduled at 1 month after termination of the 1-month intervention period
|- Trial web site|| www.amc.nl/supportcoach|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||PhD A. Bakker|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Olff|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Kansen voor West, Europees Fonds voor Regionale Ontwikkeling|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||24-feb-2015 - 13-apr-2016|