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Maintaining Mechanisms of Chronic Depression and Their Changeability (GetWell)

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ClinicalTrials.gov Identifier: NCT02801513
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : June 16, 2016
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Thorsten Barnhofer, Freie Universität Berlin

Brief Summary:
Despite considerable progress in the understanding of depression, the treatment of those who have entered a chronic course of the disorder still represents a major challenge. In order to develop more effective interventions it is important to learn more about maintaining mechanisms and the ways in which these can be addressed. Recent research has outlined aberrations in neurophysiological parameters that may serve as risk factors underlying tendencies to engage in maladaptive responses to negative mood, and that may be particularly pronounced in patients with chronic depression. Initial evidence suggests that such deficits may not be easily amenable through established treatments. The current study investigated whether mental training using mindfulness mediation, as compared to an active control training, could alter these parameters in chronically depressed patients.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Brief Mindfulness Training Behavioral: Resting Control Training Not Applicable

Detailed Description:

Persistent engagement in maladaptive patterns of thinking is a hallmark of depression. In those who suffer from a chronic course of the disorders, tendencies towards engagement in such patterns of thinking are likely to have become habitual and automatic in nature. Recent research has begun to elucidate potential cognitive and neurophysiological bases of such persistence. There is evidence that depressed patients show significant deficits in performance monitoring (Weinberg, Dieterich, & Riesel, 2015). Research on error-related negativity (ERN), a signal that occurs briefly after commission of an error, has reported significant aberrations in depressed suggesting deficits at the early stages of processing discrepancies. Deficits in ERN have been suggested to serve as an endophenotype for depression and psychopathology more generally (Manoach & Agam, 2013). Preliminary findings suggest that deficits remain even when symptoms are reduced following established treatments. Similarly, there is evidence for increased tendencies to elaborate negative information as evidenced by stronger late positive potentials (LPP; Auerbach, Stanton, Proudfit, & Pizzagalli, 2015) and an increased rigidity of spontaneous activity of the brain during rest as indicated by increased long-range temporal correlations of spontaneous brain oscillations (LRTC; Bornas et al., 2013).

Interventions using mental training may be particularly suited to address these aberrations. Indeed even brief training in mindfulness has been found to have significant neuroplastic effects (Tang et al., 2010) The aim of the current study was therefore to investigate the effects of a brief intervention using training in mindfulness meditation on the above listed parameters. Chronically depressed patients were randomly allocated to receive either a two-week mindfulness training or a resting control training. EEG was measured before and after the intervention along with self-reports of current symptoms and resilience/vulnerability factors. We expected the mindfulness training to have significantly stronger effects on ERN, LPP, and LRTC than the resting control training.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Maintaining Mechanisms of Chronic Depression and Their Changeability: the Role of Discrepancy-based Processing
Study Start Date : September 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brief Mindfulness Training
The brief mindfulness training comprised of three 1.5-hour weekly individual sessions and included intensive daily home practice. Participants were asked to engage in formal meditation practice for about 25 minutes twice per day on six out of seven days of each week using recorded guided meditations. Practices were shorter in duration than the practices in Mindfulness-Based Cognitive Therapy (MBCT, Segal et al., 2002) in order to allow for more flexibility in scheduling the practices, but followed the standard sequence of mindfulness-based interventions.
Behavioral: Brief Mindfulness Training
Brief mindfulness training comprising of three weekly individual sessions and daily guided meditation home practice
Other Name: Mindfulness Intervention

Active Comparator: Resting Control Training
The resting control training comprised of three 1.5-hour weekly individual sessions and included intensive daily home practice. Participants were asked to schedule regular rest periods as a means of deliberately retreating from the activities of the day. Length and frequency of the rest periods mirrored the time demands of the meditation training. Participants received a plausible rationale for the control training that linked acute depression to stress and suggested rest, relaxation, and disengagement from negative thinking as an initial and preliminary step towards recovery.
Behavioral: Resting Control Training
Brief resting control training comprising of three weekly individual sessions and daily home practice consisting of resting periods
Other Name: Resting Control




Primary Outcome Measures :
  1. Error-related negativity [ Time Frame: Two weeks ]
    Event-related potential (EEG)

  2. Long-range temporal correlations of theta oscillations in resting EEG [ Time Frame: Two weeks ]
    Resting EEG

  3. Late positive potentials [ Time Frame: Two weeks ]
    Event-related potential (EEG)


Secondary Outcome Measures :
  1. Levels of state mindfulness [ Time Frame: Two weeks ]
    Self-report

  2. Interoceptive awareness [ Time Frame: Two weeks ]
    Self-report

  3. Levels of depressive symptoms [ Time Frame: Two weeks ]
    Self-report

  4. Ruminative tendencies [ Time Frame: Two weeks ]
    Self-report



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a current diagnosis of Major Depression as assessed by Structured Clinical Interview for DSM IV (First, Spitzer, Gibbon, & Williams, 2002)
  • a lifetime history of depression with onset before age 19 and either chronic persistence of symptoms or a history of at least three previous episodes of depression, two of which needed to have occurred during the last two years
  • self-reported severity of current symptoms on a clinical level as indicated by Beck Depression Inventory-II (Beck, Steer, & Brown, 1996) scores above 19
  • age 25 to 60 thus excluding cases of late-onset depression, and e) fluency in spoken and written German.

Exclusion Criteria:

  • history of psychosis or mania, current eating disorder, OCD, current self-harm, current substance abuse or dependence
  • history of traumatic brain injury
  • current treatment with CBT
  • We allowed patients who were currently taking antidepressants into the study provided that the medication had not been changed during the last four weeks before entry into the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801513


Sponsors and Collaborators
Freie Universität Berlin
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Thorsten Barnhofer, PhD Freie Universität Berlin
Publications of Results:
Fissler, M. Winnebeck, E., Schroeter, T. A., Gummersbach, M., Huntexburg, J. M., Gaertner, M., & Barnhofer, T. (in press). An Investigation of the Effects of Brief Mindfulness Training on Self-Reported Interoceptive Awareness, the Ability to Decenter, and Their Role in the Reduction of Depressive Symptoms. Mindfulness.

Other Publications:
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Responsible Party: Thorsten Barnhofer, Heisenberg-Fellow, Freie Universität Berlin
ClinicalTrials.gov Identifier: NCT02801513    
Other Study ID Numbers: BA2255/3-1
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Thorsten Barnhofer, Freie Universität Berlin:
mindfulness
EEG
error-related negativity
late positive potential
long-range temporal correlations
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders