The primary objective of the study is to identify both modality-specific and modality-spanning predictors of stressor reactivity, thereby guiding the development of an in-silico model of resilience (secondary objective).
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 dynamic stress resilience (i.e. mental health
maintenance despite stressor exposure), as measured with a residuals-based
stressors reactivity score.
Secondary outcome
Several parameters are studied to unravel the time-varying, individually
variable and interactive engagement of the biological, psychological and social
resilience factors, including: biological parameters, psychological
questionnaires, neuroimaging, and ecological momentary & physiological
assessments.
Background summary
Stress-related disorders pose a significant burden on individuals, the economy,
and society in general. Each year, more than half a billion people around the
globe suffer from a mental disorder such as anxiety, post-traumatic stress
disorder, depression, or addiction that can to some extent be traced back to
the influence of exogenous or endogenous stressors (traumatic events,
challenging life circumstances or life transitions, or physical illness.
Despite huge efforts spent on investigating the pathophysiology of these
disorders and despite the big strides that have been made in developing
effective treatments, the extraordinarily high incidence of stress-related
disorders has not decreased over the past decades.
DynaMORE (Dynamic MOdelling of REsilience) aims to improve the prevention of
stress-related mental health problems by developing a dynamic in-silico model
of resilience. Resilience is maintenance and/or quick recovery of mental health
and well-being during and after times of adversity, such as trauma, difficult
life circumstances, challenging life transitions, or physical illness.
There is now ample evidence that individuals change while they successfully
cope with stressors, whether this manifests at the level of altered
perspectives on life , as emergence of new strengths or competences, as partial
immunization against the effects of future stressors , or also as epigenetic
alterations and modified gene expression patterns. Furthermore, neurobiological
studies indicate that such organismic adjustments are causal for the
preservation of mental health. Hence, resilience is not simply inertia, or
insensitivity to stressors, or merely a passive response to adversity. In the
same vein, resilience can no longer be understood simply as a stable, fixed
personality trait or predisposition (the *resilient personality*) that
guarantees long-term mental health and well-being whatever stressor the
organism is exposed to.
This contemporary view of resilience has the important consequence that
resilience cannot be measured through any one-time (cross-sectional) assessment
(e.g., a questionnaire, a brain scan, genotyping etc.) performed before
adversity occurs, as the outdated trait-like conceptualization of resilience
implies. Instead, we must closely follow the nature and time course of the
stressors an individual is exposed to as well as the changes in mental health
that these stressors may or may not induce.
As a prospective resilience study, DynaMOBS consists of a baseline assessment
of mental health, followed by mental health assessments during and after
stressor exposure. Stressor exposure is measured and quantified, such that
changes in mental health can be considered in relation to the adversity an
individual has encountered.
Study objective
The primary objective of the study is to identify both modality-specific and
modality-spanning predictors of stressor reactivity, thereby guiding the
development of an in-silico model of resilience (secondary objective).
Study design
The study follows a longitudinal design consisting of an online-prescreening;
two on-site appointments for baseline measures; six months of ambulatory
monitoring (including six days of ecological momentary & physiological
assessments and biweekly measures of stressor experience and mental health) and
three online follow-ups.
Study burden and risks
Minimal risk is associated with this study. However, subjects may experience
slight discomfort when collecting various bio-samples (blood, saliva, and
stool), when participating in particular behavioral paradigms (inducing fear or
stress) and when filling out several psychological questionnaires. Moreover,
the MRI scanner may cause discomfort to some participants due to its noise and
confined space. There is no considerable residual risk in wearing the Chill+.
However, irritation at the site of the patch, is an undesirable side-effect
that does happen in a small percentage of the users.
Kapittelweg 29
Nijmegen 6500 HB
NL
Kapittelweg 29
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Participants are healthy students (18-25 years old) who have experienced at
least three life events which were each evaluated as burdening. Participants
have a total GHQ (i.e. general health questionnaire) score * 20. Volunteers are
proficient in the Dutch language.
Exclusion criteria
The participant currently meets criteria of a relevant psychiatric disorder
except for a mild depressive episode (ICD F32.1), tobacco dependence (ICD F12)
and substance abuse as established using the Mini-International
Neuropsychiatric interview. The participant has met criteria for a relevant
psychiatric disorder except for a mild depressive episode (ICD F32.1), tobacco
dependence (ICD F12), and a substance abuse in the past 9 months. The
participant has ever been diagnosed with a severe mental or organic disorder
that affects neurodevelopment due to its pathological mechanism or treatment.
The subject*s body mass index is lower than 18 or higher than 27. The
participant is not eligible for functional magnetic resonance imaging. The
participant took any psychoactive substances 4 weeks prior to Baseline Day 1
and the MRI appointment. The participant is not eligible to wear the Chill+.
The participant is not free of COVID-19 related symptoms.The participant is
currently in psychiatric treatment. The participant receives hormonal treatment
other than oral contraceptives and/or takes steroids.
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 | NL70983.091.19 |