Symptom Based Treatment Affects Brain Plasticity - Cognitive Training in Patients With Affective Symptoms
NCT ID: NCT03183947
Last Updated: 2019-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2017-08-29
2019-12-06
Brief Summary
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Detailed Description
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Cognitive reappraisal training is an established method to improve emotion regulation. The cognitive reappraisal of a stimulus or situation works by reinterpreting the emotional stimulus or situation and can change the course of the emotional response. Over the last years this form of cognitive reappraisal training has become a standard approach in the treatment of affective disorders.
The prefrontal cortex (PFC) plays an important role in emotion regulation. In line with this it has been shown that patients with reduced emotion regulation ability display impaired functioning of the PFC. Aim of the study is to train patients to consciously upregulate activity in the PFC and thereby to increase emotion regulation ability. On the behavioral level this is expected to correlate with a reduced experience of negative mood. In order to regulate the PFC, participants are instructed to use cognitive reappraisal strategies. Cognitive reappraisal is an effective and well-investigated strategy to improve emotion regulation and is a standard cognitive-behavioral psychotherapeutic intervention. During cognitive reappraisal the meaning of a picture is reinterpreted in order to reduce the emotional reaction. Recent fMRI studies have shown that cognitive reappraisal is associated with an increase in prefrontal activity and a decrease of amygdala activation.
The new technique of real-time fMRI enables subjects to influence their brain activity in certain areas based on neurofeedback. Ongoing brain activity as measured by fMRI is reported to the participants in real time via brain computer interface (BCI). In order to influence brain activity, mental strategies are usually recommended to the participants that have been shown to increase activity in the respective area. Due to the identification of contingency between feedback and mental strategies participants are able to control their own brain activity consciously. It has been shown that psychiatric symptomatology can be improved using this non-invasive technique. In the current study it will be investigated whether neurofeedback of the PFC has a positive influence on affective symptoms in patients with depression and schizophrenia, respectively. In detail it is researched whether the upregulation of activity in the PFC can lead to an increase in subjective well-being. Two groups of patients (depression (N=40) and schizophrenia (N=40)) as well as a group of healthy participants will receive neurofeedback-training of the PFC. Aim of the study is an improvement of depressive (or negative) symptoms as well as the investigation of the impact of neurofeedback on resting-state networks in the brain.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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fMRI Neurofeedback regulation of left PFC
Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations)
fMRI
collection of functional brain data for 1 hour per day
Neurofeedback
Task of the participants is to increase the activity in the selected brain region (left or right prefrontal cortex). After regulation they will get a feedback about the regulation success. (Patients: days 3 \& 4; controls: Days 2 \& 3)
PANAS
to assess the mood before and after the fMRI and after 4 weeks during a telephone interview
BDI-II
to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview
ERQ
To assess emotion regulation strategies before and after neurofeedback training (patients: day 3\&4; controls: day 2\&3) and after 4 weeks during a telephone interview
fMRI Neurofeedback of right PFC
Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations)
fMRI
collection of functional brain data for 1 hour per day
Neurofeedback
Task of the participants is to increase the activity in the selected brain region (left or right prefrontal cortex). After regulation they will get a feedback about the regulation success. (Patients: days 3 \& 4; controls: Days 2 \& 3)
PANAS
to assess the mood before and after the fMRI and after 4 weeks during a telephone interview
BDI-II
to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview
ERQ
To assess emotion regulation strategies before and after neurofeedback training (patients: day 3\&4; controls: day 2\&3) and after 4 weeks during a telephone interview
Interventions
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fMRI
collection of functional brain data for 1 hour per day
Neurofeedback
Task of the participants is to increase the activity in the selected brain region (left or right prefrontal cortex). After regulation they will get a feedback about the regulation success. (Patients: days 3 \& 4; controls: Days 2 \& 3)
PANAS
to assess the mood before and after the fMRI and after 4 weeks during a telephone interview
BDI-II
to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview
ERQ
To assess emotion regulation strategies before and after neurofeedback training (patients: day 3\&4; controls: day 2\&3) and after 4 weeks during a telephone interview
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fluent German language skills
Exclusion Criteria
* pregnant or lactating women
* acute suicidal tendency
* persons incapable of giving consent
18 Years
75 Years
ALL
Yes
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Klaus Mathiak, Prof MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
Locations
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University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
Aachen, , Germany
Countries
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References
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Buhle JT, Silvers JA, Wager TD, Lopez R, Onyemekwu C, Kober H, Weber J, Ochsner KN. Cognitive reappraisal of emotion: a meta-analysis of human neuroimaging studies. Cereb Cortex. 2014 Nov;24(11):2981-90. doi: 10.1093/cercor/bht154. Epub 2013 Jun 13.
Hayes JP, Vanelzakker MB, Shin LM. Emotion and cognition interactions in PTSD: a review of neurocognitive and neuroimaging studies. Front Integr Neurosci. 2012 Oct 9;6:89. doi: 10.3389/fnint.2012.00089. eCollection 2012.
Kohn N, Eickhoff SB, Scheller M, Laird AR, Fox PT, Habel U. Neural network of cognitive emotion regulation--an ALE meta-analysis and MACM analysis. Neuroimage. 2014 Feb 15;87:345-55. doi: 10.1016/j.neuroimage.2013.11.001. Epub 2013 Nov 9.
Linden DE, Habes I, Johnston SJ, Linden S, Tatineni R, Subramanian L, Sorger B, Healy D, Goebel R. Real-time self-regulation of emotion networks in patients with depression. PLoS One. 2012;7(6):e38115. doi: 10.1371/journal.pone.0038115. Epub 2012 Jun 4.
Ochsner KN, Bunge SA, Gross JJ, Gabrieli JD. Rethinking feelings: an FMRI study of the cognitive regulation of emotion. J Cogn Neurosci. 2002 Nov 15;14(8):1215-29. doi: 10.1162/089892902760807212.
Weiskopf N, Scharnowski F, Veit R, Goebel R, Birbaumer N, Mathiak K. Self-regulation of local brain activity using real-time functional magnetic resonance imaging (fMRI). J Physiol Paris. 2004 Jul-Nov;98(4-6):357-73. doi: 10.1016/j.jphysparis.2005.09.019. Epub 2005 Nov 10.
Joormann J, Gotlib IH. Emotion regulation in depression: relation to cognitive inhibition. Cogn Emot. 2010 Feb 1;24(2):281-98. doi: 10.1080/02699930903407948.
Troy AS, Wilhelm FH, Shallcross AJ, Mauss IB. Seeing the silver lining: cognitive reappraisal ability moderates the relationship between stress and depressive symptoms. Emotion. 2010 Dec;10(6):783-95. doi: 10.1037/a0020262.
Keller M, Zweerings J, Klasen M, Zvyagintsev M, Iglesias J, Mendoza Quinones R, Mathiak K. fMRI Neurofeedback-Enhanced Cognitive Reappraisal Training in Depression: A Double-Blind Comparison of Left and Right vlPFC Regulation. Front Psychiatry. 2021 Aug 23;12:715898. doi: 10.3389/fpsyt.2021.715898. eCollection 2021.
Other Identifiers
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17-094
Identifier Type: -
Identifier Source: org_study_id