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Mindfulness Based Emotion Regulation Therapy in the Treatment of Depressive Rumination

Primary Purpose

Depressive Disorder, Depression, Rumination

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU)
Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring fNIRS, Rumination, Depression, Momentary Assessment, TSST, Emotion regulation therapy, Mindfulness based

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University Hospital TübingenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

No Intervention

Arm Label

Intervention group

Treatment as usual (TAU)

Control condition

Arm Description

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).

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.

Healthy subjects will get a single TSST session.

Outcomes

Primary Outcome Measures

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).
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).
TSST
Changes in behavior while and immediately after the stress induction via the Trier Social Stresstest
state rumination
Changes in state rumination while and immediately after the stress induction via the Trier Social Stresstest; increase from pre to post TSST

Secondary Outcome Measures

fNIRS TSST activation
Hemodynamic response / brain activation while control tasks and the stress induction via the Trier Social Stresstest
fNIRS Training activation
Hemodynamic response / brain activation while the mindfulness based emotion regulation therapy / training sessions
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).
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).

Full Information

First Posted
September 16, 2020
Last Updated
September 30, 2020
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT04560192
Brief Title
Mindfulness Based Emotion Regulation Therapy in the Treatment of Depressive Rumination
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depression, Rumination
Keywords
fNIRS, Rumination, Depression, Momentary Assessment, TSST, Emotion regulation therapy, Mindfulness based

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Treatment as usual (TAU)
Arm Type
Other
Arm Description
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.
Arm Title
Control condition
Arm Type
No Intervention
Arm Description
Healthy subjects will get a single TSST session.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-compassion-scale (SCS)
Description
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).
Time Frame
8-10 weeks
Title
Becks Depression Inventory (BDI)
Description
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).
Time Frame
8-10 weeks
Title
TSST
Description
Changes in behavior while and immediately after the stress induction via the Trier Social Stresstest
Time Frame
3 times in 8-10 weeks
Title
state rumination
Description
Changes in state rumination while and immediately after the stress induction via the Trier Social Stresstest; increase from pre to post TSST
Time Frame
3 times in 8-10 weeks
Secondary Outcome Measure Information:
Title
fNIRS TSST activation
Description
Hemodynamic response / brain activation while control tasks and the stress induction via the Trier Social Stresstest
Time Frame
3 times in 8-10 weeks
Title
fNIRS Training activation
Description
Hemodynamic response / brain activation while the mindfulness based emotion regulation therapy / training sessions
Time Frame
8 times in 4-5 weeks
Title
Training rating scores
Description
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).
Time Frame
8 times in 4-5 weeks
Title
Electronical momentary assessment (EMA)
Description
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).
Time Frame
2 times per day in 8-10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hendrik Laicher, M. Sc.
Phone
+49 7071 29-87103
Email
hendrik.laicher@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
David Rosenbaum, Dr.
Phone
+49 7071 29-83609
Email
david.rosenbaum@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Christine Ehlis, Dr.
Organizational Affiliation
submitter and head of the lab
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hendrik Laicher, M. Sc.
Phone
+49 7071 29-87103
Email
hendrik.laicher@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
David Rosenbaum, Dr.
Phone
+49 7071 29-86309
Email
david.rosenbaum@med.uni-tuebingen.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Mindfulness Based Emotion Regulation Therapy in the Treatment of Depressive Rumination

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