The primary objective of this study is to examine the effectiveness of a mobile application, *The SUPPORT Coach*, in reducing traumatic stress symptoms among traumatized adults with traumatic stress. The secondary objective is to investigate the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychotrauma klachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter is the difference in traumatic stress symptoms
(continuous PCL-5 scores) between the intervention and control condition
directly after termination of the intervention period.
Secondary outcome
Secundary outcomes of the study include the potential reduction in negative
cognitions about the trauma (PTCI), increase in psychological resilience (RES)
and perceived social support (SSL-6) in the intervention group. Furthermore,
user satisfaction with the SUPPORT Coach will be evaluated and user logs will
be explored for implementation-information purposes.
Background summary
After experiencing a potentially traumatic event, people are at increased risk
to develop mental health problems, in particular traumatic stress symptoms.
These mental health problems are a serious burden, both for individuals and the
society. Mobile health offers an easily accessible and low-cost opportunity to
reduce traumatic stress symptoms in the aftermath of trauma.
Study objective
The primary objective of this study is to examine the effectiveness of a mobile
application, *The SUPPORT Coach*, in reducing traumatic stress symptoms among
traumatized adults with traumatic stress. The secondary objective is to
investigate the effectiveness of the mobile application in reducing negative
cognitions about the traumatic event(s) and enhancing resilience and social
support.
Study design
This is a randomized controlled trial (RCT) in which, after an online screening
(n = 800), 276 participants will be either randomized to the intervention
condition (one-month unlimited access to the SUPPORT Coach; n = 138) or to the
control condition (no access to the SUPPORT Coach, n = 138). Participants in
both condition have access to their own (mental) care if necessary. As this
study is not conducted with patients, mental health care consumption may vary
across participants.
Intervention
The intervention group gets unlimited access (during one month) to *The SUPPORT
Coach, a mobile application designed to support individuals with traumatic
stress symptoms in better understanding and self-managing their symptoms. The
app includes information on 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. The control group will not
receive access to the SUPPORT Coach. Participants in both condition have access
to their own (mental) care if necessary.
Study burden and risks
The burden and risks associated with participation in this study are minimal.
The estimated time for a participant to complete the online questionnaires is
80 minutes for the entire study. Topics of the questionnaires include life
events, traumatic stress symptoms, psychological resilience, coping,
depression-, anxiety-, and stress symptoms, perceived social support,
demographics, work and absenteeism. Participants in the intervention condition
can use the app at their own discretion. The U.S. version of the mobile app was
previously positively evaluated among adults with posttraumatic stress
symptoms. Participants in both condition have access to their own (mental) care
if necessary.
Meibergdreef 5
Amsterdam 1105 AZ
NL
Meibergdreef 5
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- 18 years and older
- Sufficient proficiency in Dutch language
- Only participants with traumatic stress symptoms (measured by online screening) will be randomised into one of the two trial arms
Exclusion criteria
- No informed consent
- No smartphone or tablet
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL48552.018.14 |
| OMON | NL-OMON29192 |