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Symptom Based Treatment Affects Brain Plasticity - Cognitive Training in Patients With Affective Symptoms (APIC-II)

Primary Purpose

Depression, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
fMRI
Neurofeedback
PANAS
BDI-II
ERQ
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring fMRI, neurofeedback, emotion regulation, schizophrenia, cognitive reappraisal, depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • any contraindication to MRI examination or claustrophobia
  • pregnant or lactating women
  • acute suicidal tendency
  • persons incapable of giving consent

Sites / Locations

  • University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

fMRI Neurofeedback regulation of left PFC

fMRI Neurofeedback of right PFC

Arm Description

Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations)

Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations)

Outcomes

Primary Outcome Measures

change in self-control over neuronal activity in PFC
fMRI-BCI as a measure before and after the regulation of the brain activity

Secondary Outcome Measures

Changes from baseline in brain plasticity
fMRI as a measure for brain plasticity before and after neurofeedback
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
specificity of left or right PFC neurofeedback
change in resting state brain activation
Resting state fMRI as a measure before and after neurofeedback
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

Full Information

First Posted
June 2, 2017
Last Updated
December 6, 2019
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT03183947
Brief Title
Symptom Based Treatment Affects Brain Plasticity - Cognitive Training in Patients With Affective Symptoms
Acronym
APIC-II
Official Title
Symptom Based Treatment Affects Brain Plasticity - Cognitive Training in Patients With Affective Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
December 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Schizophrenia
Keywords
fMRI, neurofeedback, emotion regulation, schizophrenia, cognitive reappraisal, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fMRI Neurofeedback regulation of left PFC
Arm Type
Experimental
Arm Description
Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations)
Arm Title
fMRI Neurofeedback of right PFC
Arm Type
Experimental
Arm Description
Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations)
Intervention Type
Procedure
Intervention Name(s)
fMRI
Other Intervention Name(s)
functional magnetic resonance imaging
Intervention Description
collection of functional brain data for 1 hour per day
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
PANAS
Other Intervention Name(s)
Positive And Negative Affect Scales
Intervention Description
to assess the mood before and after the fMRI and after 4 weeks during a telephone interview
Intervention Type
Other
Intervention Name(s)
BDI-II
Other Intervention Name(s)
Beck's depression inventory
Intervention Description
to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview
Intervention Type
Other
Intervention Name(s)
ERQ
Other Intervention Name(s)
Emotion regulation questionnaire
Intervention Description
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
Primary Outcome Measure Information:
Title
change in self-control over neuronal activity in PFC
Description
fMRI-BCI as a measure before and after the regulation of the brain activity
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Changes from baseline in brain plasticity
Description
fMRI as a measure for brain plasticity before and after neurofeedback
Time Frame
2 weeks
Title
Change in pathology (depression)
Description
BDI-II as a measure of the intensity and quality of depressive symptoms before training and 4 weeks following the intervention
Time Frame
4 weeks after interventions
Title
specificity of left or right PFC neurofeedback
Time Frame
2 weeks
Title
change in resting state brain activation
Description
Resting state fMRI as a measure before and after neurofeedback
Time Frame
2 weeks
Title
Change in pathology (mood)
Description
Positive And Negative Affect Scales (PANAS) as a measure of mood before and after the fMRI and after 4 weeks during a telephone interview
Time Frame
4 weeks after interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: any contraindication to MRI examination or claustrophobia pregnant or lactating women acute suicidal tendency persons incapable of giving consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Mathiak, Prof MD PhD
Organizational Affiliation
University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23765157
Citation
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Results Reference
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PubMed Identifier
23087624
Citation
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.
Results Reference
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PubMed Identifier
24220041
Citation
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. Erratum In: Neuroimage. 2015 May 1;111():631.
Results Reference
background
PubMed Identifier
22675513
Citation
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.
Results Reference
background
PubMed Identifier
12495527
Citation
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.
Results Reference
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PubMed Identifier
16289548
Citation
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.
Results Reference
background
PubMed Identifier
20300538
Citation
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.
Results Reference
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PubMed Identifier
21058843
Citation
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.
Results Reference
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PubMed Identifier
34497546
Citation
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.
Results Reference
derived

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Symptom Based Treatment Affects Brain Plasticity - Cognitive Training in Patients With Affective Symptoms

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