The primary objective is to investigate if the stress-induced dynamics across stress systems are impaired in patients with CT-related depression compared to non-CT-related depression and healthy controls. The secondary objective is to examine how…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the laboratory stress system dynamics measured by
resting state brain function directly (0 - 40 minutes) and later (60-100
minutes) after the stress (TSST) or control (placebo-TSST) test.
Secondary outcome
Secondary study parameters are stress system dynamics measured through
task-related fMRI activity and behavior, endocrine responses during stress,
perceived stress and anxiety during stress, and (psycho)physiological
responses, as well as daily life stress reactivity, including physiological and
psychological measures, measured by ecological momentary and physiological
assessment.
Background summary
Childhood trauma (CT) is a significant risk factor for several psychiatric
disorders including major depressive disorder (MDD). Not only does it increase
the risk of onset, but CT-related depression has been shown to critically
differ from non-CT-related depression in its earlier emergence, more severe and
recurrent symptoms, and worse treatment outcomes. While a wealth of evidence
demonstrates altered stress system functionality across the life span following
exposure to CT in relation to depression, it is currently unknown which
CT-related changes in development of the stress system explain why individuals
with CT-related depression have poor outcomes at adult age. Recent work has
made clear that dynamic functionality of the stress system is key to an
adequate and coordinated stress response, spanning across several modalities
including endocrine responses, brain functions/networks, and behavioral
responses. We hypothesize that impaired dynamics in the stress response is
central in the persistent vulnerability of patients with CT-related depression.
Specifically, we hypothesize that mood disorder patients with CT have a reduced
proficiency for dynamic adaptation of brain function, which is necessary after
stress. This would then result in an impaired response to stress compared to
non-CT mood disorder patients and healthy controls, with lower stress-induced
(de)activation and connectivity of the salience network, executive control
network, and default mode network. We expect that this loss of normal
stress-related functional network dynamics also relates to altered
physiological and psychological responses to stress in daily life.
Study objective
The primary objective is to investigate if the stress-induced dynamics across
stress systems are impaired in patients with CT-related depression compared to
non-CT-related depression and healthy controls. The secondary objective is to
examine how stress system dynamics in the laboratory translate to real-life
stress in daily life in these three groups.
Study design
The study is designed as a randomized cross-over study with two experimental
conditions (stress condition and placebo-stress condition, separated by at
least 2 weeks).
Intervention
Participants will undergo the trier social stress test (TSST) and a placebo
version of the trier social stress test (placebo-TSST).
Study burden and risks
A moderate risk for participants is estimated. Participants will have to
complete several questionnaires which may be perceived as a burden; however,
research has shown that the burden is low, including questionnaires related to
CT, and that participants experience their participation as positive and
beneficial. In addition, the stress test (Trier Social Stress Test; TSST) is a
validated and standardized test to induce mild psychosocial stress in a
laboratory setting and is often applied without any known lasting
disadvantageous effects, on its own as well as in combination with MRI,
including in patient groups with psychiatric disorders (e.g., schizophrenia,
bipolar disorder, and depression). In the MRI scanner, participants will be
exposed to a magnetic field for less than 1.5 hours. This is not dangerous and
poses no risk as long as no metal objects are located on the participant, as
these can be heated or magnetized. Therefore, all participants will be informed
in advance and checked for the presence of metal in or on the body. The time
spent in the laboratory is limited to 4 hours per visit and participants have
sufficient time for breaks and will be compensated for their time. Participants
will provide their saliva five times per visit (10 times in total) by chewing
on a cotton pad for 1 minute, which they can do independently. Written
instructions on how this works are shared with all participants beforehand, but
the researcher will also be present in case any further assistance is needed.
Tools used for physiological and psychological assessment of daily life stress
reactivity are safe and cause limited interference with daily activities.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
General inclusion criteria:
- Mastery of Dutch language
- Age of >= 18 years
- Willingness and ability to give written informed consent
- Normal or corrected-to-normal vision
Additional inclusion criteria for the patient groups (i.e., MDD+CT and MDD-CT):
- Moderate to severe depression
- Score >= 26 on the Inventory of Depressive Symptoms-Self Report
(IDS-SR) (Rush et al., 2000)
- DSM-5 diagnosis of major depression disorder (MDD), confirmed with clinical
interview (MINI (Sheehan et al., 1997))
Additional inclusion criteria for the MDD+CT group:
- Moderate to severe childhood trauma (CT) before the age of 18
- Score above validated cut-off for moderate to severe CT using the
Childhood Trauma Questionnaire (CTQ) (Bernstein et al., 1994):
Exclusion criteria
General exclusion criteria:
- Speech impairments
- Other lifetime severe psychiatric comorbidity (bipolar disorder, psychotic
disorder) or current alcohol/drug dependence
- Primary diagnosis of post-traumatic stress disorder (PTSD) or Acute Stress
Disorder (ASD)
- Lifetime diagnosis of borderline personality disorder (BPD)
- Any acute somatic or acute endocrine disease (e.g., acute asthma)
- Taking any medication known to influence endocrine systems
- Chronic benzodiazepine use (and sporadic use on the days of the lab visits)
- Neurological disorder
- Known contraindications for MRI investigations, such as the presence of metal
objects (e.g., pacemaker, arteriovenous clips) or severe claustrophobia.
Additional exclusion criteria for healthy controls and MDD-CT patients:
- Moderate to severe childhood trauma (CT) before the age of 18
- Score above validated cut-off for moderate to severe CT using CTQ
(see cutoff scores
above)
Additional exclusion criteria for healthy controls:
- Past or present psychiatric condition.
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 | NL81663.029.22 |