The objective of the proposed project is to develop knowledge and algorithms that can be used in a mobile application combined with a wearable that supports individuals with ASD and other psychiatric disorders in self-managing their stress (daily…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters/endpoints in the effect evaluation are: perceived
acute and daily stress levels (and patterns over time), stress coping
behaviours and quality of life.
Secondary outcome
not applicable to this study
Background summary
Psychiatric disorders are life-long disorders characterized by stigma (Holubova
et al., 2019) and social and communication impairments (American Psychiatric
Association, 2013). Patients with schizophrenia, depression, anxiety,
personality disorders, bipolar disorder, depression and autism spectrum
disorders (ASD) experience more stress than the general population (Connor et
al., 2007; Ghorbani et al., 2008; Streit et al., 2016). This is partly due to
more negative life events, less social support and les self-confidence
(Faravelli et al., 2007; Goodyer et al., 1985; Pruessner et al., 2011). Patient
with a psychiatric disorder are less able to deal with stress due to inadequate
and ineffective coping strategies. Chronic stress also negatively affects the
quality of life (Bishop-Fitzpatrick et al., 2018; Hong et al., 2016; Jepsen et
al., 2019) and the course of the disorder (Chabungbam et al., 2007).
In short, there is a need for real-time support of people with psychiatric
disorders in self-managing their stress in their daily life. Existing
signalling schemes are not an adequate solution, because a lot of individuals
with psychiatric disorders lack the capability to proactively act upon such
schemes. There is a wide array of mental health applications available, but
recent review studies showed that the majority of these apps lack scientific
evidence about their efficacy (Byambasuren et al., 2018; Donker et al., 2013;
Lui, 2017). For individuals with ASD, who need specific ways of communication
and visualisation, multiple apps are available that help them engage in social
contact and that offer ready-made or do-it-yourself visual schedules for daily
living tasks and time management (e.g. AutThere, Daymate, Psymate). However,
none of the available digital tools developed for individuals with ASD focus on
supporting proactive self-managing of stress in daily lives. Therefore, we
developed the application SAM (Stress Autism Mate) in our former study. SAM is
tailor made for patients with autism, since they have special needs for the
feel and touch of the application. SAM was tested and used for four weeks and
has been proven to reduce daily stress, to improve stress coping strategies and
to improve the QoL of individuals with ASD, for the short and longer term. The
SAM study participants were also more able to ask for help when needed. Because
of the success of SAM, we want to do further research with SAM and research its
possibilities. First the design and content (algorithms and communication) of
the application will be further optimized and tailored to individuals using the
application. Also, additional algorithms will be developed in which we combine
data from different measurement moments to give more insight into individual
stress patterns over time. This resulting new version of the app will be tested
again among a group of individuals with autism. Second, feedback given by
patients participating in our former study were the lack of the opportunity to
signal and cope with acute stress moments. They were curious whether a wearable
added to SAM could make a difference in their daily life stress and emotion
regulation experience additionally to the already accomplished benefits of SAM.
To do so, possibilities and limitations of adding physiological measurements to
the prototype app SAM to be able to measure acute stress will be explored. To
this end, an already existing wearable, to be determined, will be added to the
use of SAM to detect acute stress using physiological measurements (e.g. heart
rate, heart rate variability, of skin conductance) (Hufnagel et al., 2017; Kim
et al., 2018). Finally, as part of this project, the application will be
converted to be accessible for individuals with psychiatric disorders, like
depression, schizophrenia, bipolar disorder, anxiety, personality disorder
(e.g. stress signalling application, STAPP). The effectiveness of different
functions of the application for individuals with different psychiatric
disorders will be tested in this study.
The approach of SAM and STAPP is based on the positive health movement defining
health not as the absence of illness but as the capability to cope with health
impairments (Huber et al., 2011).
Study objective
The objective of the proposed project is to develop knowledge and algorithms
that can be used in a mobile application combined with a wearable that supports
individuals with ASD and other psychiatric disorders in self-managing their
stress (daily and acute stress) in real time. And to investigate whether
self-managing stress decreases perceived acute and daily stress, improves
stress coping behaviours and quality of life for different psychiatric
conditions.
Study design
To evaluate the effectiveness of the adjusted SAM and the STAPP application, we
use an aggregated single-case study design. We use this method to detect
intra-individual effects of an intervention on behavioural change (Spreen et
al., 2010). In this particular study, we are not only interested in whether the
intervention works for a particular client but also whether its effect can be
generalized on population level. In this aggregated single-case study, multiple
cases or participants are involved and repeatedly measured over time (Shadish &
Sullivan, 2011). *While group designs typically give information about the
effect of a treatment on *an average case*, and single-case designs give
information about the effect on a specific case, a set of single-case studies
combines the strengths of both designs* ( Van den Noortgate, & Onghena, 2015).
Intervention
A mobile application that supports individuals with a psychiatric disorder in
self-managing their daily and acute stress. The applications will consist of
three functionalities: monitoring, feedback, and advice. Using the application,
individuals monitor their stress levels in real time, they receive feedback
about their stress levels over the past days, and if needed receive advice on
managing their stress. They also receive feedback and advice on acute moments
of stress. The project aims to develop the knowledge and technology needed for
this. The ultimate goal is to improve their functional performance and
perceived quality of life.
Study burden and risks
A very important requirement for the success of this project is the
participation of the target group. Without their active involvement in the
study, we will not be able to develop an application that suits their needs and
preferences and test the effectiveness and usability of the application.
A burden could be that individuals with psychiatric disorders and their
families have to invest time into this project to get a tailor-made
application. A risk may be that the individuals become more aware of the
stressful things in their lives due to participation in this project. This
could negatively affect their state of mind. On the other hand, involved
individuals get direct access to tools to cope with this daily stress and the
opportunity to improve their resilience and their coping strategies with
respect to daily experienced stress. An algorithm is built in the application
that urges individuals to contact their practitioner whenever stress levels are
very high.
Randstad 20-27c
Almere 1314 BC
NL
Randstad 20-27c
Almere 1314 BC
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study a subject must meet the
following criteria:
Having a clinical psychiatric diagnosis according to the DSM V: depression,
anxiety personality disorder, obsessive compulsive disorder, autism spectrum
disorder, psychotic disorder or bipolair disorder, an IQ above 85. Age above 18
years.
Exclusion criteria
IQ under 85
no understanding of the dutch language
Design
Recruitment
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 | NL73308.028.20 |