The primary objective of the study is to predict the effect of a given ecological momentary intervention (either ReApp or Imager) based on acquired baseline measures. Further, the use of DBMs to generate an objective stressor reactivity score is…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
stress-gerelateerde klachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is dynamic stress resilience as measured with a
residuals-based stressors reactivity score.
Secondary outcome
Changes in resilience in relation to the given EMI are associated with
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. 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.
Study objective
The primary objective of the study is to predict the effect of a given
ecological momentary intervention (either ReApp or Imager) based on acquired
baseline measures. Further, the use of DBMs to generate an objective stressor
reactivity score is investigated (secondary objective) and we will validate the
in-silico model that was developed in DynaMOBS.
Study design
The study follows a longitudinal design consisting of an online-prescreening;
on-site appointments for baseline measures; four months of ambulatory training
and assessments (including EMA, EPA, and EMI); bio-samples, and biweekly
measures of stressor experience, mental health and resilience factors as well
as three online follow-ups.
Intervention
Participants will be randomly allocated to receive either an EMI that boosts
positive reappraisal (ReApp) or an EMI that boosts reward sensitivity (Imager).
Study burden and risks
Minimal risk is associated with this study. However, subjects may experience
slight discomfort when collecting various bio- samples (blood and stool) 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 6525EN
NL
Kapittelweg 29
Nijmegen 6525EN
NL
Listed location countries
Age
Inclusion criteria
Participants are healthy students (18-27 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 reports the use of alcohol 24 hours before the second test baseline
test battery. The participant took any psychoactive substances 4 weeks prior to
the first or second baseline test battery. The participant is not eligible to
wear the Chill+ or eligible for functional MRI. 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. The participant has participated in the
DynaMOBS study, and/or any study including a fear conditioning and/or stress
induction paradigm, and/or any study using an EMI similar to ReApp or Imager.
The participant has a full beard.
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 | NL78981.091.21 |