Trial document





This trial has been registered retrospectively.
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  DRKS00006314

Trial Description

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Title

Effectiveness of a mindful depression treatment of acute depression in a day clinic setting

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study was designed to investigate the effectiveness and long-term effectiveness of a mindfulness based treatment of acute depression in a day clinic of the psychiatric department of the Asklepios Klinikum Hamburg-Harburg (Germany). Participants, meeting inclusion criteria of moderate to severe acute depression, were randomly assigned to one of two study conditions - they either took part in the psychopharmacological consultation condition (PCC) prior to admission to the day clinic or during the mindfulness-based treatment of depression at the day clinic (MDT-DC). The aim of the study was to examine the effectiveness of the mindful treatment concept on depression symptoms, work ability and behavior, as well as mindfulness and self-compassion. Furthermore, effects of treatment on intuitive decision-making processes as well as explicit and implicit psychological processes (emotions, self-esteem) were examined in a sub-sample.

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Brief Summary in Scientific Language

The number of patients seeking therapeutic help due to work-related fatigue and the resulting symptoms of stress and depression is increasing. The findings suggest that mindfulness-based interventions are beneficial for patients with stress symptoms and acute depression. This randomized controlled trial (N = 77) was conducted to evaluate the effectiveness and long-term effectiveness of an eight-week mindful depression treatment in a day clinic setting (MDT-DC), specializing in adult patients with acute depression and work-related conflicts. Participants were randomly assigned to either MDT-DC or a psychopharmacological consultation control (PCC) condition. The survey was carried out in the MDT-DC over the course of the treatment, in the PCC in the waiting period before starting the treatment. A follow-up in the MDT-DC took place eight months after the end of treatment.

Our main objective was to investigate whether the MDT-DC, compared to PCC, leads to clinically significant reductions in self-reported depression symptoms at the end of treatment. Other goals included determining whether MDT-DC significantly improves work ability and changes in work-related behavioral patterns. In addition, we wanted to investigate whether the treatment duration of eight weeks was sufficient to support changes in life functioning (e.g., solving interpersonal conflicts) during the course of the therapy process. Another goal was to investigate possible mechanisms of action (mindfulness and self-compassion) in the treatment. In a sub-sample (n = 39), we also examined the influence of the treatment on intuitive decision-making processes and explored the change in implicit indicators of self-esteem and mood and their relationship with explicit measures.

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Organizational Data

  •   DRKS00006314
  •   2018/05/23
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  •   yes
  •   Approved
  •   /, Hildesheim - Ethikkommission des Fachbereichs Erziehungs- und Sozialwissenschaften; Universität Hildesheim
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Secondary IDs

  •   U1111-1212-8793 
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Health Condition or Problem studied

  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
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Interventions/Observational Groups

  •   Mindful depression treatment in a day clinic (MDT-DC). MDT-DC follows a structured and intense eight-week treatment concept in which the cultivation of a mindful mindset (i.e. practicing to adopt an accepting, non-judgmental attitude and focus one’s attention on the here-and-now) is at the core of the group therapy treatment rationale. The focus, throughout the treatment, lies on work related conflicts, resulting stress and interpersonal situations in which patients learn to apply a mindful mindset (e.g., adopting a non-judgmental attitude when facing conflicting interpersonal interests as opposed to reacting automatically). Patients receive a daily treatment of 225 minutes and are instructed in both formal (e.g., sitting meditation) and informal (e.g., walking) mindfulness practice each day. Over the course of eight weeks, patients receive 150 hours of treatment in total.
  •   Psychopharmacological Consultation Condition (PCC). The effects of the MDT-DC were compared to a control condition in which patients waited to receive the treatment and were meanwhile given psychopharmacological consultation. It should be ensured that the two groups did not show differences in medication. For this reason, patients of the PCC received an individualized written medical recommendation for their general practitioner or psychiatrist from the same physicians of the day clinic that also consulted patients of the MDT-DC. This consultation took place at the beginning of the study to equate the medical treatment during the waiting time with the usual medical treatment in the clinic. All patients of the PCC received the MDT-DC treatment after completion of the study.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Depression symptoms (Becks Depression Inventory, BDI-II): The Depression symptoms were determined during the study at a four-week interval - at the beginning of the study, at the middle of the study, and at the end of the study, as well as at follow-up, eight months after the end of the study.

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Secondary Outcome

Work ability (Work Ability Index, WAI), work-related behavior and experience pattern (German questionnaire: Arbeitsbezogenes Verhaltens- und Erlebensmuster; AVEM), therapy process (German questionnaire: Fragebogen zu Evaluation von Psychotherapieverläufen, FEP), mindfulness (Kentucky Inventory of Mindfulness Skills, KIMS), self-compassion (Self-Compassion Scale, SCS), semantic and visual coherent Intuition (Bowers et al., 1990), implicit mood (Implicit Positive and Negative Affect Test , IPANAT), explicit mood (Positive and Negative Affect Schedule, PANAS), implicit self-esteem (Nuttin, 1985), explicit self-esteem (Rosenberg Scale; Rosenberg, 1965):

The work ability, mindfulness, and work-related behavior and experience patterns were determined at the beginning and at the end of the study, as well as at follow-up, eight months after end of treatment. The therapy process and self-compassion were determined every two weeks from the beginning of the study. Self-compassion was additionally determined at follow-up. The semantic and visual coherence tasks, as well as mood and self-esteem measurements, were determined at the beginning, the middle of the study, and at the end of the study.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/04/07
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   67   Years
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Additional Inclusion Criteria

Diagnostic eligibility for the study was determined with the Structured Clinical Interview for DSM-IV for depression (SCID; First et al. 1997; German version: Wittchen et al. 1997). Inclusion criteria were a diagnosis of a current moderate or severe depressive episode.

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Exclusion Criteria

The exclusion criteria included history of schizophrenia or schizoaffective disorder, personality disorder, organic mental disorder, eating disorder, and current substance abuse. Furthermore, we excluded patients with long-term unemployment as the treatment concept has a clear focus on actual work-related conflicts and behavior.

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Addresses

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    • Asklepios Klinikum Harburg, Zentrum für Seelische Gesundheit
    • Mr.  Dr.  Hans-Peter  Unger 
    • Eißendorfer Pferdeweg 52
    • 21075  hamburg
    • Germany
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    • Universität Hildesheim
    • Ms.  Dr. Dipl.-Psych.  Carina  Remmers 
    • Universitätspl. 1
    • 31141  Hildesheim
    • Germany
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    • Universität Witten/Herdecke, Department für Psychologie und Psychotherapie
    • Mr.  Prof.  Johannes  Michalak 
    • Alfred-Herrhausen-Straße 44
    • 58455  Witten
    • Germany
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    • Asklepios Klinikum Harburg, Zentrum für Seelische Gesundheit
    • Ms.  Alice  Buxton 
    • Eißendorfer Pferdeweg 52
    • 21075  Hamburg
    • Germany
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    • Asklepios Klinikum Harburg, Zentrum für Seelische Gesundheit
    • Ms.  Alice  Buxton 
    • Eißendorfer Pferdeweg 52
    • 21075  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Asklepios proresearch
    • Lohmühlenstraße 5
    • 20099  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/02/01
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Trial Publications, Results and other Documents

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