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
1 other identifier
interventional
96
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 16, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedOctober 1, 2020
September 1, 2020
12 months
September 16, 2020
September 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Self-compassion-scale (SCS)
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)
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
Changes in behavior while and immediately after the stress induction via the Trier Social Stresstest
3 times in 8-10 weeks
state rumination
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 Outcomes (4)
fNIRS TSST activation
3 times in 8-10 weeks
fNIRS Training activation
8 times in 4-5 weeks
Training rating scores
8 times in 4-5 weeks
Electronical momentary assessment (EMA)
2 times per day in 8-10 weeks
Study Arms (3)
Intervention group
ACTIVE COMPARATORTreatment 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).
Treatment as usual (TAU)
OTHERNo 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.
Control condition
NO INTERVENTIONHealthy subjects will get a single TSST session.
Interventions
1. In each of 8 sessions (allocated over 4 weeks) the patient brings an (actual) topic that induces rumination. After identifying the underlying affect, the patients are instructed (1) to concentrate on it, (2) to accept and tolerate it (considering the personal situation and experiences), (3) to give it a new interpretation so the patient can look at it with a more generous view, and (4) to dissociate from it, so the patient can perceive it as one of many affects and as one that hasn't the power to influence one's thoughts and actions that much (as it does through rumination). These steps are gradually instructed and trained throughout 20 trials (à 40 seconds) in each session. After each trial there is room to talk about the trial, possible barriers and helpful strategies to overcome those. Between-sessions the patients are encouraged to train the strategies in their daily life and do some homework like a protocol of ruminative thoughts and meditation. 2. Waiting period with TAU.
1. Waiting period with TAU. 2. In each of 8 sessions (allocated over 4 weeks) the patient brings an (actual) topic that induces rumination. After identifying the underlying affect, the patients are instructed (1) to concentrate on it, (2) to accept and tolerate it (considering the personal situation and experiences), (3) to give it a new interpretation so the patient can look at it with a more generous view, and (4) to dissociate from it, so the patient can perceive it as one of many affects and as one that hasn't the power to influence one's thoughts and actions that much (as it does through rumination). These steps are gradually instructed and trained throughout 20 trials (à 40 seconds) in each session. After each trial there is room to talk about the trial, possible barriers and helpful strategies to overcome those. Between-sessions the patients are encouraged to train the strategies in their daily life and do some homework like a protocol of ruminative thoughts and meditation.
Eligibility Criteria
You may qualify if:
- age: 18-60
- german as mother tongue
- diagnosis of a unipolar depressive disorder
- ruminative processes in the psychopathology
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Related Publications (1)
Laicher H, Int-Veen I, Woloszyn L, Wiegand A, Kroczek A, Sippel D, Leehr EJ, Lawyer G, Albasini F, Frischholz C, Mossner R, Nieratschker V, Rubel J, Fallgatter A, Ehlis AC, Rosenbaum D. In situ fNIRS measurements during cognitive behavioral emotion regulation training in rumination-focused therapy: A randomized-controlled trial. Neuroimage Clin. 2023;40:103525. doi: 10.1016/j.nicl.2023.103525. Epub 2023 Oct 13.
PMID: 37839195DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ann-Christine Ehlis, Dr.
submitter and head of the lab
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2020
First Posted
September 23, 2020
Study Start
July 1, 2020
Primary Completion
June 30, 2021
Study Completion
June 30, 2022
Last Updated
October 1, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After publication
- Access Criteria
- Requester should have a scientistic (i.e. thematically related or complementary) interest in the data.
Other researchers can get IPD of interest after request.