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Completed

NCT Number: NCT02801513

Maintaining Mechanisms of Chronic Depression and Their Changeability

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Mindfulness Training

Behavioral

Brief mindfulness training comprising of three weekly individual sessions and daily guided meditation home practice

Other names: Mindfulness Intervention

Resting Control Training

Behavioral

Brief resting control training comprising of three weekly individual sessions and daily home practice consisting of resting periods

Other names: Resting Control

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Freie Universität Berlin

Other

Collaborators

  • Charite University, Berlin, Germany

Registry information

Official study title

Maintaining Mechanisms of Chronic Depression and Their Changeability: the Role of Discrepancy-based Processing

Acronym: GetWell

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 16, 2016
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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