Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
48

Summary

Conditions
  • Depression
  • Depressive Disorder
  • Rumination
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

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 depress...

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.

Tracking Information

NCT #
NCT04560192
Collaborators
Not Provided
Investigators
Study Chair: Ann-Christine Ehlis, Dr. submitter and head of the lab