NCT02801513

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable major-depressive-disorder

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

June 11, 2016

Last Update Submit

June 15, 2016

Conditions

Keywords

mindfulnessEEGerror-related negativitylate positive potentiallong-range temporal correlations

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

EXPERIMENTAL

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.

Behavioral: Brief Mindfulness Training

Resting Control Training

ACTIVE COMPARATOR

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.

Behavioral: Resting Control Training

Interventions

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

Also known as: Mindfulness Intervention
Brief Mindfulness Training

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

Also known as: Resting Control
Resting Control Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

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: 25643205BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 23882201BACKGROUND
  • 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.

    PMID: 20713717BACKGROUND
  • 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.

    PMID: 25746725BACKGROUND
  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Thorsten Barnhofer, PhD

    Freie Universität Berlin

    PRINCIPAL INVESTIGATOR

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