We investigate: (1) whether young women can be grouped according to distinct trajectories of depressive symptom change, measured with the Major Depression Inventory (MDI), over a period of 8 months following the breakup of a romantic relationship; (…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are listed for each of our six objectives. (1) MDI
scores, measured every two weeks (2) cognitive control ability, measured three
times during the study (3) neural processing of reward and punishment during
the Monetary Incentive Delay (MID) task in the fMRI scanner (4) brain activity
and FC during resting-state fMRI scanning, (5) rumination scores and
resting-state FC data (6) resting-state fMRI data collected both before and
after the task-based fMRI scanning session.
Secondary outcome
Secondary outcomes of objective 2 will be trait rumination and degree of
neuroticism. The secondary outcome of objective 3 will be behavioral
performance during the MID task.
Background summary
Upsetting life-events are known to be risk factors for the development of
depressive symptoms. Possibly, individual differences in coping with upsetting
events can (partly) explain individual differences in vulnerability for
developing depressive symptoms. Mediating aspects previously suggested comprise
personality factors including rumination and neuroticism, cognitive control and
reward-related processes, as well as aberrant brain functional connectivity
(FC), specifically in the default mode network (DMN) and task-control related
networks. In this study, we will use subjects with a recent romantic
relationship breakup as an experimental human model. Studying people who have
just experienced the breakup of a relationship will allow us to investigate
mood disturbances, and associated brain alterations, in individuals without a
psychiatric disorder. This way, we can provide new insights into factors that
play a role in dealing with upsetting events and vulnerability factors for the
development of depressive symptoms.
Study objective
We investigate: (1) whether young women can be grouped according to distinct
trajectories of depressive symptom change, measured with the Major Depression
Inventory (MDI), over a period of 8 months following the breakup of a romantic
relationship; (2) effects of trait rumination and neuroticism on cognitive
control abilities among the different trajectory groups; (3) whether processing
of reward and punishment can be seen as a marker of the different trajectory
groups; (4) to what extent patterns of brain activity can be used to
distinguish group trajectory membership; (5) differences in rumination-related
brain activity patterns across trajectory groups and to what extent these
differences can be explained by rumination trait, rumination state or both; (6)
the impact and/or confound of task-related effects on the participants`
baseline resting-state.
Study design
We will follow subjects with a recent relationship breakup for a period of 30
weeks and assess symptoms of depression over time. Subjects come three times to
our laboratory to fill in questionnaires and perform cognitive tasks. The last
visit includes an fMRI scanning session. In between the three visits, subjects
will complete a brief online questionnaire concerning depressive symptoms every
two weeks.
Study burden and risks
Subjects will fill in questionnaires and perform cognitive tasks during three
visits in this study. In addition, subjects will receive an invitation to a
brief online questionnaire every two weeks. During the last visit, subjects
will also undergo MRI scanning. During the fMRI session, subjects perform the
MID task and undergo scanning while resting. Time inside the fMRI scanner will
be approximately 50 minutes. The study will not entail more than minimal risk
to the subjects. Concerning the fMRI scanner, subjects will be exposed to a
field strength of 3 Tesla and to the noise of the scanner. Thus far, there is
no evidence to suggest that exposing humans to a magnetic field of this
strength has any negative influence on health. With regard to the noise,
earplugs will be provided. The study is not intended to benefit the subjects
directly. However, the data collected during this study will enhance our
understanding of coping with upsetting events and vulnerability factors for the
development of depressive symptoms. Subjects involved in the study will receive
a compensation of ¤75 at the end of the last visit. Subjects who decide to
withdraw from the study will receive financial compensation on a pro rata
basis. Compensation for questionnaire administration and cognitive task
performance will be ¤9 per hour. Compensation for MRI scanning will be ¤20.
Furthermore, an additional compensation for travel expenses will be made
available, if necessary.
Van Royenlaan 26b
Groningen 9721 ER
NL
Van Royenlaan 26b
Groningen 9721 ER
NL
Listed location countries
Age
Inclusion criteria
Age between 18 and 35 years
Caucasian ethnicity
Heterosexual
Right-handed
Dutch as a native language
Dissolution of a romantic relationship in the preceding two months at the time
of giving written informed consent
Relationship duration (prior to breakup) of at least six months
Exclusion criteria
Presence of a neurological disorder (such as epilepsy)
Presence of a psychiatric disorder
Vision problems that cannot be corrected
(suspected) Pregnancy
Claustrophobia
MR incompatible implants or objects in the body
Tattoos containing pigments that form a safety risk
The refusal to be informed of structural abnormalities that could be detected
during the experiment
Design
Recruitment
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 | NL66208.042.18 |
| Other | NTR candidate number: 29251 |
| OMON | NL-OMON25623 |