Depression Clinical Trial
Official title:
Analysis of the Neuronal Correlates of a Mindfulness Based Emotion Regulation Therapy in the Treatment of Depressive Rumination Untersuchung Der Neuronalen Korrelate Eines Emotionsregulationstrainings Zur Behandlung Depressiven Grübelns
In this study the investigators are examining the neuronal processes of a mindfulness based
emotion regulation training for reducing depressive rumination. The research of depressive
rumination helps in the developement of new therapies for depressive disorders.
Goal of this project is to have a look at the coherences between stress, mindfulness
resources, depressive rumination and their neuronal correlates. Therefore the investigators
are collecting the data of 48 patients with a depressive diagnosis in a randomized
intervention-study with a treatment as usual (TAU) waiting-control-list versus an active
intervention group. An additional 48 healthy control subjects are planned to be measured.
In a randomized and (for gender and severity of depressive symptomatic) outbalanced design
the investigators are examining the neuronal processes of a mindfulness based emotion
regulation training (MBERT) for reducing depressive rumination in a cross-over design.
Therefore 48 patients with a depressive disorder get a MBERT that consists of one
psychoeducative session and 8 therapy sessions.
For checking the efficacy of the MBERT each patient runs three times through the Trier Social
Stress Test (TSST). As the study design is a cross-over design, half of the patients get the
MBERT in block 1 (i.e. between the first and the second TSST) and half of the patients get
the MBERT in block 2 (i.e. between the second and the third TSST). In the block where they
don't receive the MBERT the patients don't get any treatment within the scope of the study
(waiting period), but any treatment as usual (TAU), including pharmacotherapy and
psychotherapy, can be continued and started at each point of the study.
For analyzing the neuronal processes the investigators are measuring the cerebral oxygenation
using functional near-infrared-spectroscopy (fNIRS) during the TSSTs as well as during the 8
therapy sessions.
Using an ecological momentary assessment (EMA), the investigators additionally are collecting
data of the actual stress level, stressful events, rumination, equanimity, self-compassion,
mindfulness and sleep quality two times a day. Thus the investigators can (1) observe the
individual reaction to stress in the daily life, and (2) recheck if the patients are able to
transfer the learned strategies from the MBERT in their daily life. For those patients that
received the MBERT in the first block the investigators (3) additionally have data to
evaluate the sustainability (i.e. the lasting effectivity) of the MBERT.
As a control condition, 48 healthy subjects will get a single TSST session.
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