Mindfulness Based Emotion Regulation Therapy in the Treatment of Depressive Rumination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depressive Disorder Depression Rumination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU)

Intervention Type BEHAVIORAL

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.

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.

Group Type OTHER

Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)

Intervention Type OTHER

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.

Control condition

Healthy subjects will get a single TSST session.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU)

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.

Intervention Type BEHAVIORAL

Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)

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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes