Maintaining Mechanisms of Chronic Depression and Their Changeability
GetWell
1 other identifier
interventional
74
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable major-depressive-disorder
Started Sep 2013
Shorter than P25 for not_applicable major-depressive-disorder
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 11, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedJune 16, 2016
June 1, 2016
1.5 years
June 11, 2016
June 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Error-related negativity
Event-related potential (EEG)
Two weeks
Long-range temporal correlations of theta oscillations in resting EEG
Resting EEG
Two weeks
Late positive potentials
Event-related potential (EEG)
Two weeks
Secondary Outcomes (4)
Levels of state mindfulness
Two weeks
Interoceptive awareness
Two weeks
Levels of depressive symptoms
Two weeks
Ruminative tendencies
Two weeks
Study Arms (2)
Brief Mindfulness Training
EXPERIMENTALThe 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.
Resting Control Training
ACTIVE COMPARATORThe 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.
Interventions
Brief mindfulness training comprising of three weekly individual sessions and daily guided meditation home practice
Brief resting control training comprising of three weekly individual sessions and daily home practice consisting of resting periods
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Freie Universität Berlinlead
- Charite University, Berlin, Germanycollaborator
Related Publications (7)
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.
PMID: 25643205BACKGROUNDBornas, 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
BACKGROUNDManoach 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.
PMID: 23882201BACKGROUNDTang 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.
PMID: 20713717BACKGROUNDWeinberg 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.
PMID: 25746725BACKGROUNDFissler, 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.
RESULTBarnhofer 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.
PMID: 34213860DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thorsten Barnhofer, PhD
Freie Universität Berlin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Heisenberg-Fellow
Study Record Dates
First Submitted
June 11, 2016
First Posted
June 16, 2016
Study Start
September 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 16, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share