Trial document




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  DRKS00005222

Trial Description

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Title

Experimental studies on rumination and mindfulness: A multilevel approach using fMRI and ambulatory assessment in clinical and nonclinical samples

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Trial Acronym

Experimental studies on rumination and mindfulness

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URL of the Trial

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Brief Summary in Lay Language

During the first funding period (2010-2013), the project investigated effects of rumination and mindfulness on emotional, cognitive and stress-related hormonal activity (cortisol secretion) processes in daily life and brain activity during negative mood, rumination, and mindful self-focus in currently remitted depressed patients and healthy controls. In the present funding period (2013-2016) we investigate whether daily life rumination and brain activity assessed during the first funding phase can predict the longer-term course of illness in our patients. Therefore, these patients will be followed up after three years, and depressed symptoms, habitual rumination, and the course of illness during the three years will be assessed by means of interviews and questionnaires. We expect that higher rumination, worse mood states and a decreased cortisol response towards subjective experiences in daily life as well as specific alterations in brain activity patterns during negative mood and rumination (assessed in the first funding phase) will predict a worse course of symptoms and an increased risk of relapse/recurrence. In a further substudy we will investigate effects of a four-week mindfulness-oriented attention training (n=35) against an active control condition (progressive muscle relaxation, n=35) on spontaneous rumination, mood, and cortisol secretion in daily life, on habitual mindfulness, as well as on characteristics of the autobiographical memory in a new sample of remitted depressed individuals. We expect that the mindfulness training will lead to a stronger decrease in specific brain activation patterns, to a more substantial reduction in daily rumination, to larger increases in autobiographical memory specificity and to higher habitual mindfulness.

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Brief Summary in Scientific Language

During the first funding period (2010-2013), the project investigated functional connectivity and neural correlates of induced attention foci (rumination, mindfulness) using fMRI, and effects of spontaneous and induced attention foci on emotional, cognitive and endocrinological processes in daily life in remitted depressed patients (≥2 episodes) and healthy controls. In this context, we examine the relationship between results of both measurement levels (fMRI, ambulatory assessment, AA) and their predictive value for the course of symptoms. By integrating both research approaches, our project pursues an as yet completely new approach in the area of rumination and mindfulness research. In the second funding period (2013-2016) we aim at investigating AA- and fMRI-based predictors identified during the first funding period with regard to their potential to predict the long-term symptom course and risk of relapse/recurrence in patients, as well as at investigating intervention effects of a specific mindfulness-based attention training on neural and everyday parameters in a new sample of patients.
Substudy 1 intends to conduct a concluding three-year-follow-up of the remitted depressed patients (n=60) investigated in study period 1. This allows an examination of long-term predictive effects of depression-related alterations in AA- and fMRI-based variables for the longterm course of symptoms in this already extensively characterized sample. Amongst others, we assume that increased daily rumination, worse mood states and a decreased cortisol response towards subjective experiences in daily life will predict a worse course of symptoms and an increased risk of relapse/recurrence. We also expect that the increased functional connectivity identified within the Default Mode Network (DMN) in patients during negative mood and rumination induction will predict a disadvantageous course of symptoms over the three-year period. Finally, we expect that the relationship between degree of functional connectivity at baseline and the course of symptoms will be mediated by the degree of daily rumination at baseline.
Substudy 2 aims to investigate the short-term effects of a four-week mindfulness-based attention training (n=35) compared to a time-matched active control condition (progressive muscle relaxation, n=35) in a randomised experimental intervention study on changes in functional connectivity of the DMN as well as rumination, emotional processes, and cortisol activity in daily life in a new sample of remitted recurrent depressed patients. In particular, we expect that the mindfulness training will lead to a stronger decrease in functional connectivity in the DMN, to a more substantial reduction in daily rumination, and to larger increases in autobiographical memory specificity and habitual mindfulness. Finally, we expect that improvements in daily rumination will mediate the effect of the intervention on functional connectivity in the DMN.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005222
  •   2013/08/20
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  •   yes
  •   Approved
  •   2009-299N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F33.4 -  Recurrent depressive disorder, currently in remission
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Interventions/Observational Groups

  •   Mindfulness based short intervention.
    Four-week training of mindfulness-based attention adapted from Williams et al. (2009). Training practice on sixdays per week, each 40min, instructions pr CD. Additionally 5 sessions with meditation-experienced trainer (1*week a 50min., 1* before, 3*during, 1*end of intervention). Instruction of exercises, Check of training progress) indfulness based short intervention
  •   Progressive muscle relaxation. Four-week training of progressive muscle relaxation (PMR). Training practice on six days per week, each 40min, instructions pr CD. Additionally 5 sessions with PMR-experienced trainer (1*week a 50min, 1* before, 3*during, 1*end of intervention). Instruction of exercises, check of training progress)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

daily life rumination
assessed by ambulatory assessment (assessments on four days each immediately before and after the intervention, 8 measuring points per day, pseudorandomized time points)

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Secondary Outcome

Default Mode Network connectivity during sad mood induction during fMRT, 1* immediately before and after the intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/08/01
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

unipolar depressives in remission

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Exclusion Criteria

bipolar and psychotic disorders, substance dependence, OCD, PTBS, Eating Disorders

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Addresses

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    • Zentralinstitut für Seelische Gesundheit
    • Ms.  Prof.Dr.  Christine  Kühner 
    • Postfach 122120
    • 68072  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr.  Peter  Kirsch 
    • Postfach 122120
    • 68072  Mannheim
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Zentralinstitut für Seelische Gesundheit
    • Ms.  Prof. Dr.  Christine  Kühner 
    • Postfach 122120
    • 68072  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Ms.  Prof. Dr.  Christine  Kühner 
    • Postfach 122120
    • 68072  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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