DepressionAPIC-IINCT03183947
Symptom Based Treatment Affects Brain Plasticity - Cognitive Training in Patients With Affective Symptoms
A study testing fMRI, Neurofeedback and PANAS in people with Depression and Schizophrenia, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of the study is the examination of brain plasticity on on affective symptoms after neuromodulation with fMRI (functional magnetic resonance imaging) neurofeedback. During the fMRI neurofeedback training, patients with depression as well as patients with schizophrenia are trained to consciously regulate the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Schizophrenia
- What is being tested?
- fMRI, Neurofeedback and PANAS
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- 29 Aug 2017to 6 Dec 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Depression according to ICD-10 (F32.x, F33.x, F31.3 or F34.x); Schizophrenia according to ICD-10 (F2x); or healthy subjects
- Fluent German language skills
Who cannot join
- any contraindication to MRI examination or claustrophobia
- pregnant or lactating women
- acute suicidal tendency
- persons incapable of giving consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
Aachen, 52074
About this study
The aim of the study is the examination of brain plasticity on on affective symptoms after neuromodulation with fMRI (functional magnetic resonance imaging) neurofeedback. During the fMRI neurofeedback training, patients with depression as well as patients with schizophrenia are trained to consciously regulate the activity of areas which are associated with the cognitive reappraisal of emotional stimuli.The aim is to improve the patients' subjective emotional processing and perception in everyday life as well as to investigate the impact of neurofeedback on resting-state networks in the brain. Healthy participants will be investigated as control group.
Read the detailed description
The ability to regulate emotions is a central element of mental health that is significantly affected in various psychiatric disorders. Its importance for development and maintenance of depressive symptomatology has been widely shown; e.g. patients with depression have a significantly reduced ability to regulate emotions in response to negative stimuli. However, emotion regulation abilities may pose as an important resilience factor that can counteract the development of depressive symptoms. The loss of the ability to regulate emotions is not only observed in depression, but is also a core factor in negative symptoms of schizophrenia.
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
- Depression, Schizophrenia
- Being tested
- fMRI, Neurofeedback, PANAS, BDI-II, ERQ
- Keywords
- fMRI, neurofeedback, emotion regulation, schizophrenia, cognitive reappraisal, depression
- Medical subject headings
- Depression, Schizophrenia, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIProcedure or surgery
Also called functional magnetic resonance imaging
collection of functional brain data for 1 hour per day
NeurofeedbackBehavioural
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)
PANASOther
Also called Positive And Negative Affect Scales
to assess the mood before and after the fMRI and after 4 weeks during a telephone interview
BDI-IIOther
Also called Beck's depression inventory
to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview
ERQOther
Also called Emotion regulation questionnaire
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
| Study group | Role | What they receive |
|---|---|---|
| fMRI Neurofeedback regulation of left PFC | Experimental | Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations) Receives: Procedure: fMRI; Behavioral: Neurofeedback; Other: PANAS; Other: BDI-II; Other: ERQ |
| fMRI Neurofeedback of right PFC | Experimental | Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations) Receives: Procedure: fMRI; Behavioral: Neurofeedback; Other: PANAS; Other: BDI-II; Other: ERQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in self-control over neuronal activity in PFC
fMRI-BCI as a measure before and after the regulation of the brain activity
Measured: 1 week
Secondary outcomes (5)
Changes from baseline in brain plasticity
fMRI as a measure for brain plasticity before and after neurofeedback
Measured: 2 weeks
Change in pathology (depression)
BDI-II as a measure of the intensity and quality of depressive symptoms before training and 4 weeks following the intervention
Measured: 4 weeks after interventions
specificity of left or right PFC neurofeedback
Measured: 2 weeks
change in resting state brain activation
Resting state fMRI as a measure before and after neurofeedback
Measured: 2 weeks
Change in pathology (mood)
Positive And Negative Affect Scales (PANAS) as a measure of mood before and after the fMRI and after 4 weeks during a telephone interview
Measured: 4 weeks after interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start29 Aug 2017
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaus Mathiak, Prof MD PhD, Principal investigator, University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183947
- Sponsor's protocol ID
- 17-094
- Acronym
- APIC-II
- Status last verified
- Dec 2019
- First submitted
- 2 Jun 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23765157Hayes 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.
PubMed 23087624Kohn 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.
PubMed 24220041Linden 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.
PubMed 22675513Ochsner 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.
PubMed 12495527Weiskopf 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.
PubMed 16289548Joormann J, Gotlib IH. Emotion regulation in depression: relation to cognitive inhibition. Cogn Emot. 2010 Feb 1;24(2):281-98. doi: 10.1080/02699930903407948.
PubMed 20300538Troy 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.
PubMed 21058843Keller 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.
PubMed 34497546
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Based Treatment Affects Brain Plasticity - Cognitive Training in Patients With Affective Symptoms
- ClinicalTrials.gov ID
- NCT03183947
- Acronym / sponsor ID
- APIC-II / 17-094
- Conditions
- Depression, Schizophrenia
- Keywords
- fMRI, neurofeedback, emotion regulation, schizophrenia, cognitive reappraisal, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 12 Jun 2017 (actual)
- 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.
The aim of the study is the examination of brain plasticity on on affective symptoms after neuromodulation with fMRI (functional magnetic resonance imaging) neurofeedback. During the fMRI neurofeedback training, patients with depression as well as patients with schizophrenia are trained to consciously regulate the activity of areas which are associated with the cognitive reappraisal of emotional stimuli.The aim is to improve the patients' subjective emotional processing and perception in everyday life as well as to investigate the impact of neurofeedback on resting-state networks in the brain. Healthy participants will be investigated as control group.
Detailed description
The ability to regulate emotions is a central element of mental health that is significantly affected in various psychiatric disorders. Its importance for development and maintenance of depressive symptomatology has been widely shown; e.g. patients with depression have a significantly reduced ability to regulate emotions in response to negative stimuli. However, emotion regulation abilities may pose as an important resilience factor that can counteract the development of depressive symptoms. The loss of the ability to regulate emotions is not only observed in depression, but is also a core factor in negative symptoms of schizophrenia.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fMRI Neurofeedback regulation of left PFC | Experimental | Procedure: fMRI, Behavioral: Neurofeedback, Other: PANAS, Other: BDI-II, Other: ERQStudy related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations) |
| fMRI Neurofeedback of right PFC | Experimental | Procedure: fMRI, Behavioral: Neurofeedback, Other: PANAS, Other: BDI-II, Other: ERQStudy related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Depression according to ICD-10 (F32.x, F33.x, F31.3 or F34.x); Schizophrenia according to ICD-10 (F2x); or healthy subjects
- Fluent German language skills
Key exclusion criteria (4 listed)
- any contraindication to MRI examination or claustrophobia
- pregnant or lactating women
- acute suicidal tendency
- persons incapable of giving consent
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 |
|---|---|---|
| fMRIAlso: functional magnetic resonance imagingcollection of functional brain data for 1 hour per day | Procedure or surgery | fMRI Neurofeedback of right PFC, fMRI Neurofeedback regulation of left PFC |
| NeurofeedbackTask 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) | Behavioural | fMRI Neurofeedback of right PFC, fMRI Neurofeedback regulation of left PFC |
| PANASAlso: Positive And Negative Affect Scalesto assess the mood before and after the fMRI and after 4 weeks during a telephone interview | Other | fMRI Neurofeedback of right PFC, fMRI Neurofeedback regulation of left PFC |
| BDI-IIAlso: Beck's depression inventoryto assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview | Other | fMRI Neurofeedback of right PFC, fMRI Neurofeedback regulation of left PFC |
| ERQAlso: Emotion regulation questionnaireTo 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 | fMRI Neurofeedback of right PFC, fMRI Neurofeedback regulation of left PFC |
Primary outcome
change in self-control over neuronal activity in PFC
Time frame: 1 week
fMRI-BCI as a measure before and after the regulation of the brain activity
5 secondary outcomes
Changes from baseline in brain plasticity
Time frame: 2 weeks
Change in pathology (depression)
Time frame: 4 weeks after interventions
specificity of left or right PFC neurofeedback
Time frame: 2 weeks
change in resting state brain activation
Time frame: 2 weeks
Change in pathology (mood)
Time frame: 4 weeks after interventions
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 10 Dec 2019.
- Background: PubMed 23765157Buhle 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.
- Background: PubMed 23087624Hayes 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.
- Background: PubMed 24220041Kohn 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.
- Background: PubMed 22675513Linden 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.
- Background: PubMed 12495527Ochsner 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.
- Background: PubMed 16289548Weiskopf 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.
- Background: PubMed 20300538Joormann J, Gotlib IH. Emotion regulation in depression: relation to cognitive inhibition. Cogn Emot. 2010 Feb 1;24(2):281-98. doi: 10.1080/02699930903407948.
- Background: PubMed 21058843Troy 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.
- Derived from this study: PubMed 34497546Keller 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.
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Survivorship
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.
Klaus Mathiak, Prof MD PhD principal investigator
University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI, Neurofeedback and PANAS in people with Depression and Schizophrenia, run by RWTH Aachen University at 1 site in Germany.
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 2 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 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
change in self-control over neuronal activity in PFC (time frame: 1 week). 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 NCT03183947, which also lists 9 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 10 Dec 2019.