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: Unknown
• Conditions: Depressive Disorder; Depression; Rumination
• Intervention / Treatment: Behavioral: Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU); Other: Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)

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: Interventional
• Enrollment (Anticipated): 96
• 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

• Germany
  • Baden-Württemberg
    • 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: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

3

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).	Behavioral: Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU); 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.; Waiting period with TAU.
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.	Other: Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT); Waiting period with TAU.; 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.
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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
fNIRS TSST activation	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	Hemodynamic response / brain activation while the mindfulness based emotion regulation therapy / training sessions	8 times in 4-5 weeks
Training rating scores	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)	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: University Hospital Tuebingen
• Investigators: Study Chair: Ann-Christine Ehlis, Dr., submitter and head of the lab

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Depression; fNIRS; Rumination; Momentary Assessment; TSST; Emotion regulation therapy; Mindfulness based
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Mood Disorders; Feeding and Eating Disorders; Gastrointestinal Diseases; Depression; Depressive Disorder; Rumination Syndrome; Feeding and Eating Disorders of Childhood
• Other Study ID Numbers: 159/2018BO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Other researchers can get IPD of interest after request.
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: Requester should have a scientistic (i.e. thematically related or complementary) interest in the data.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No