Mindfulness Based Emotion Regulation Therapy in the Treatment of Depressive Rumination

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560192
• Other study ID #: 159/2018BO1
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2020
• Source: University Hospital Tuebingen
• Contact: Hendrik Laicher, M. Sc.
• Phone: +49 7071 29-87103
• Email: hendrik.laicher[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Feeding and Eating Disorders of Childhood
• Rumination

Intervention

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) - 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.

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	TSST	Changes in behavior while and immediately after the stress induction via the Trier Social Stresstest	3 times in 8-10 weeks
Primary	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	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
Secondary	fNIRS Training activation	Hemodynamic response / brain activation while the mindfulness based emotion regulation therapy / training sessions	8 times in 4-5 weeks
Secondary	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
Secondary	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