Maintaining Mechanisms of Chronic Depression and Their Changeability

Major Depressive Disorder Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801513
• Other study ID #: BA2255/3-1
• Status: Completed
• Phase: N/A
• First received: June 11, 2016
• Last updated: June 15, 2016
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: June 2016
• Source: Freie Universität Berlin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Brief Mindfulness Training
Brief mindfulness training comprising of three weekly individual sessions and daily guided meditation home practice
• Resting Control Training
Brief resting control training comprising of three weekly individual sessions and daily home practice consisting of resting periods

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Freie Universität Berlin	Charite University, Berlin, Germany

References & Publications (6)

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. — View 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

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

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. — View 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. — View 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):276-99. doi: 10.1016/j.ijpsycho.2015.02.029. Epub 2015 Mar 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Error-related negativity	Event-related potential (EEG)	Two weeks	No
Primary	Long-range temporal correlations of theta oscillations in resting EEG	Resting EEG	Two weeks	No
Primary	Late positive potentials	Event-related potential (EEG)	Two weeks	No
Secondary	Levels of state mindfulness	Self-report	Two weeks	No
Secondary	Interoceptive awareness	Self-report	Two weeks	No
Secondary	Levels of depressive symptoms	Self-report	Two weeks	No
Secondary	Ruminative tendencies	Self-report	Two weeks	No