- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560192
Mindfulness Based Emotion Regulation Therapy in the Treatment of Depressive Rumination
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.
Study Overview
Status
Conditions
Detailed 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 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hendrik Laicher, M. Sc.
- Phone Number: +49 7071 29-87103
- Email: hendrik.laicher@med.uni-tuebingen.de
Study Contact Backup
- Name: David Rosenbaum, Dr.
- Phone Number: +49 7071 29-83609
- Email: david.rosenbaum@med.uni-tuebingen.de
Study Locations
-
-
Baden-Württemberg
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Tübingen, Baden-Württemberg, Germany, 72076
- Recruiting
- University Hospital Tübingen
-
Contact:
- Hendrik Laicher, M. Sc.
- Phone Number: +49 7071 29-87103
- Email: hendrik.laicher@med.uni-tuebingen.de
-
Contact:
- David Rosenbaum, Dr.
- Phone Number: +49 7071 29-86309
- Email: david.rosenbaum@med.uni-tuebingen.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age: 18-60
- german as mother tongue
- diagnosis of a unipolar depressive disorder
- ruminative processes in the psychopathology
Exclusion Criteria:
- pregnancy
- acute or chronic disorder or medical treatment of such that might influence the cerebral metabolism:
- Diabetes mellitus (E10-E14 in ICD-10)
- Renal insufficiency apart from stadium 3 in Kidney Disease Outcomes Quality Initiative
- non adjusted hypertonus (I10.x in ICD-10)
- medium-severe or severe craniocerebral injury (GCS 3-12) / craniocerebral injury of 2. or 3. degree with loss of consciousness of > 30 minutes
- any medication except oral contraceptives
- other axis-I / axis-II disorders as main diagnosis
- comorbid neurological disease
- psychotic symptoms
- acute suicidality & very severe depressive symptomatology (BDI-II Score > 40)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention group
Treatment with the mindfulness based emotion regulation therapy (MBERT) in block 1, no study-treatment in block 2 (but patients receive their possibly already started treatment as usual including pharmacotherapy and psychotherapy).
|
|
Other: Treatment as usual (TAU)
No study-treatment in block 1 (but patients receive their possibly already started treatment as usual including pharmacotherapy and psychotherapy), treatment with the mindfulness based emotion regulation therapy (MBERT) in block 2.
|
|
No Intervention: Control condition
Healthy subjects will get a single TSST session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-compassion-scale (SCS)
Time Frame: 8-10 weeks
|
Changes in self compassion through the mindfulness based emotion regulation therapy.
Minimum value: 1; maximum value: 5; higher values mean better self compassion (i.e. a better outcome).
|
8-10 weeks
|
Becks Depression Inventory (BDI)
Time Frame: 8-10 weeks
|
Changes in depressive symptomatic through the mindfulness based emotion regulation therapy.
Minimum value: 0; maximum value: 63; higher values mean more severe depressive symptoms (i.e. a worse outcome).
|
8-10 weeks
|
TSST
Time Frame: 3 times in 8-10 weeks
|
Changes in behavior while and immediately after the stress induction via the Trier Social Stresstest
|
3 times in 8-10 weeks
|
state rumination
Time Frame: 3 times in 8-10 weeks
|
Changes in state rumination while and immediately after the stress induction via the Trier Social Stresstest; increase from pre to post TSST
|
3 times in 8-10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fNIRS TSST activation
Time Frame: 3 times in 8-10 weeks
|
Hemodynamic response / brain activation while control tasks and the stress induction via the Trier Social Stresstest
|
3 times in 8-10 weeks
|
fNIRS Training activation
Time Frame: 8 times in 4-5 weeks
|
Hemodynamic response / brain activation while the mindfulness based emotion regulation therapy / training sessions
|
8 times in 4-5 weeks
|
Training rating scores
Time Frame: 8 times in 4-5 weeks
|
Friendliness (with oneself and ones emotions) as well as emotional distancing while the mindfulness based emotion regulation therapy / training sessions via single questions after each trial.
Ratings range from 0 to 9, while the higher the score the more the friendliness or the emotional distancing (i.e. higher scores mean a better outcome).
|
8 times in 4-5 weeks
|
Electronical momentary assessment (EMA)
Time Frame: 2 times per day in 8-10 weeks
|
Self compassion, rumination, mindfulness, subjective stress and sleep quality in the daily routine (recorded via momentary assessment).
Therefore items from different questionnaires (Self compassion scale (SCS), Ruminative Response Scale (RRS), Perseverative Cognitions Questionnaire (PCQ)) and self created items were taken.
For self compassion, rumination and mindfulness mean scores can be calculated afterwards (self compassion: min: 0, max: 100; rumination & mindfulness: min: 0, max: 5; for self compassion and mindfulness higher scores mean a better outcome, for rumination higher scores mean a worse outcome).
|
2 times per day in 8-10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ann-Christine Ehlis, Dr., submitter and head of the lab
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 159/2018BO1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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