Major Depressive DisorderGetWellNCT02801513
Maintaining Mechanisms of Chronic Depression and Their Changeability
A study testing Brief Mindfulness Training in people with Major Depressive Disorder, run by Freie Universität Berlin.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Brief Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Maintaining Mechanisms of Chronic Depression and Their Changeability: the Role of Discrepancy-based Processing
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.
Read the detailed 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Brief Mindfulness Training, Resting Control Training
- Keywords
- mindfulness, EEG, error-related negativity, late positive potential, long-range temporal correlations
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Mindfulness TrainingBehavioural
Also called Mindfulness Intervention
Brief mindfulness training comprising of three weekly individual sessions and daily guided meditation home practice
Resting Control TrainingBehavioural
Also called Resting Control
Brief resting control training comprising of three weekly individual sessions and daily home practice consisting of resting periods
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Resting Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error-related negativity
Event-related potential (EEG)
Measured: Two weeks
Long-range temporal correlations of theta oscillations in resting EEG
Resting EEG
Measured: Two weeks
Late positive potentials
Event-related potential (EEG)
Measured: Two weeks
Secondary outcomes (4)
Levels of state mindfulness
Self-report
Measured: Two weeks
Interoceptive awareness
Self-report
Measured: Two weeks
Levels of depressive symptoms
Self-report
Measured: Two weeks
Ruminative tendencies
Self-report
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freie Universität Berlin
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Thorsten Barnhofer, Freie Universität Berlin
- Investigators
- Thorsten Barnhofer, PhD, Principal investigator, Freie Universität Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801513
- Sponsor's protocol ID
- BA2255/3-1
- Acronym
- GetWell
- Status last verified
- Jun 2016
- First submitted
- 11 Jun 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25643205Bornas, 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
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.
PubMed 23882201Tang 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.
PubMed 20713717Weinberg 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.
PubMed 25746725Fissler, 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.
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.
PubMed 34213860
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Mechanisms of Chronic Depression and Their Changeability: the Role of Discrepancy-based Processing
- ClinicalTrials.gov ID
- NCT02801513
- Acronym / sponsor ID
- GetWell / BA2255/3-1
- Conditions
- Major Depressive Disorder
- Keywords
- mindfulness, EEG, error-related negativity, late positive potential, long-range temporal correlations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Freie Universität BerlinUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Mindfulness Training | Experimental | Behavioral: Brief Mindfulness TrainingThe 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 comparator | Behavioral: Resting Control TrainingThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Mindfulness TrainingAlso: Mindfulness InterventionBrief mindfulness training comprising of three weekly individual sessions and daily guided meditation home practice | Behavioural | Brief Mindfulness Training |
| Resting Control TrainingAlso: Resting ControlBrief resting control training comprising of three weekly individual sessions and daily home practice consisting of resting periods | Behavioural | Resting Control Training |
Primary outcome
Error-related negativity
Time frame: Two weeks
Event-related potential (EEG)
Long-range temporal correlations of theta oscillations in resting EEG
Time frame: Two weeks
Resting EEG
Late positive potentials
Time frame: Two weeks
Event-related potential (EEG)
4 secondary outcomes
Levels of state mindfulness
Time frame: Two weeks
Interoceptive awareness
Time frame: Two weeks
Levels of depressive symptoms
Time frame: Two weeks
Ruminative tendencies
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Background: PubMed 25643205Auerbach 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.
- BackgroundBornas, 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: PubMed 23882201Manoach 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.
- Background: PubMed 20713717Tang 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.
- Background: PubMed 25746725Weinberg 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.
- Results publicationFissler, 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.
- Derived from this study: PubMed 34213860Barnhofer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Barnhofer, PhD principal investigator
Freie Universität Berlin
Questions about this trial
What is this clinical trial studying?
A study testing Brief Mindfulness Training in people with Major Depressive Disorder, run by Freie Universität Berlin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error-related negativity (time frame: Two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02801513, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.