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Maintaining Mechanisms of Chronic Depression and Their Changeability (GetWell)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief Mindfulness Training
Resting Control Training
Sponsored by
Freie Universität Berlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring mindfulness, EEG, error-related negativity, late positive potential, long-range temporal correlations

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Brief Mindfulness Training

    Resting Control Training

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Error-related negativity
    Event-related potential (EEG)
    Long-range temporal correlations of theta oscillations in resting EEG
    Resting EEG
    Late positive potentials
    Event-related potential (EEG)

    Secondary Outcome Measures

    Levels of state mindfulness
    Self-report
    Interoceptive awareness
    Self-report
    Levels of depressive symptoms
    Self-report
    Ruminative tendencies
    Self-report

    Full Information

    First Posted
    June 11, 2016
    Last Updated
    June 15, 2016
    Sponsor
    Freie Universität Berlin
    Collaborators
    Charite University, Berlin, Germany
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02801513
    Brief Title
    Maintaining Mechanisms of Chronic Depression and Their Changeability
    Acronym
    GetWell
    Official Title
    Maintaining Mechanisms of Chronic Depression and Their Changeability: the Role of Discrepancy-based Processing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Freie Universität Berlin
    Collaborators
    Charite University, Berlin, Germany

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    mindfulness, EEG, error-related negativity, late positive potential, long-range temporal correlations

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    74 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brief Mindfulness Training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Resting Control Training
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Brief Mindfulness Training
    Other Intervention Name(s)
    Mindfulness Intervention
    Intervention Description
    Brief mindfulness training comprising of three weekly individual sessions and daily guided meditation home practice
    Intervention Type
    Behavioral
    Intervention Name(s)
    Resting Control Training
    Other Intervention Name(s)
    Resting Control
    Intervention Description
    Brief resting control training comprising of three weekly individual sessions and daily home practice consisting of resting periods
    Primary Outcome Measure Information:
    Title
    Error-related negativity
    Description
    Event-related potential (EEG)
    Time Frame
    Two weeks
    Title
    Long-range temporal correlations of theta oscillations in resting EEG
    Description
    Resting EEG
    Time Frame
    Two weeks
    Title
    Late positive potentials
    Description
    Event-related potential (EEG)
    Time Frame
    Two weeks
    Secondary Outcome Measure Information:
    Title
    Levels of state mindfulness
    Description
    Self-report
    Time Frame
    Two weeks
    Title
    Interoceptive awareness
    Description
    Self-report
    Time Frame
    Two weeks
    Title
    Levels of depressive symptoms
    Description
    Self-report
    Time Frame
    Two weeks
    Title
    Ruminative tendencies
    Description
    Self-report
    Time Frame
    Two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thorsten Barnhofer, PhD
    Organizational Affiliation
    Freie Universität Berlin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25643205
    Citation
    Auerbach RP, Stanton CH, Proudfit GH, Pizzagalli DA. Self-referential processing in depressed adolescents: A high-density event-related potential study. J Abnorm Psychol. 2015 May;124(2):233-45. doi: 10.1037/abn0000023. Epub 2015 Feb 2.
    Results Reference
    background
    Citation
    Bornas, X., Noguera, M., Balle, M., Morillas-Romero, A., Aguayo-Siquier, B., Tortella-Feliu, M., & Llabrés, J. (2013). Long-Range Temporal Correlations in Resting EEG. Journal of Psychophysiology, 27(2), 60-66. doi:10.1027/0269-8803/a000087
    Results Reference
    background
    PubMed Identifier
    23882201
    Citation
    Manoach DS, Agam Y. Neural markers of errors as endophenotypes in neuropsychiatric disorders. Front Hum Neurosci. 2013 Jul 18;7:350. doi: 10.3389/fnhum.2013.00350. eCollection 2013.
    Results Reference
    background
    PubMed Identifier
    20713717
    Citation
    Tang YY, Lu Q, Geng X, Stein EA, Yang Y, Posner MI. Short-term meditation induces white matter changes in the anterior cingulate. Proc Natl Acad Sci U S A. 2010 Aug 31;107(35):15649-52. doi: 10.1073/pnas.1011043107. Epub 2010 Aug 16.
    Results Reference
    background
    PubMed Identifier
    25746725
    Citation
    Weinberg A, Dieterich R, Riesel A. Error-related brain activity in the age of RDoC: A review of the literature. Int J Psychophysiol. 2015 Nov;98(2 Pt 2):276-299. doi: 10.1016/j.ijpsycho.2015.02.029. Epub 2015 Mar 4.
    Results Reference
    background
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    34213860
    Citation
    Barnhofer T, Reess TJ, Fissler M, Winnebeck E, Grimm S, Gartner M, Fan Y, Huntenburg JM, Schroeter TA, Gummersbach M, Bajbouj M, Holzel BK. Effects of Mindfulness Training on Emotion Regulation in Patients With Depression: Reduced Dorsolateral Prefrontal Cortex Activation Indexes Early Beneficial Changes. Psychosom Med. 2021 Jul-Aug 01;83(6):579-591. doi: 10.1097/PSY.0000000000000955.
    Results Reference
    derived

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    Maintaining Mechanisms of Chronic Depression and Their Changeability

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