Major Depressive Disorder Clinical Trial
— GetWellOfficial title:
Maintaining Mechanisms of Chronic Depression and Their Changeability: the Role of Discrepancy-based Processing
Verified date | June 2016 |
Source | Freie Universität Berlin |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Freie Universität Berlin | Charite University, Berlin, Germany |
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
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 |
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