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

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ClinicalTrials.gov Identifier: NCT03183947
Recruitment Status : Not yet recruiting
First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment Phase
Depression Schizophrenia Procedure: fMRI Behavioral: Neurofeedback Other: PANAS Other: BDI-II Other: ERQ Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Symptom Based Treatment Affects Brain Plasticity - Cognitive Training in Patients With Affective Symptoms
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: fMRI Neurofeedback regulation of left PFC
Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations)
Procedure: fMRI
collection of functional brain data for 1 hour per day
Other Name: functional magnetic resonance imaging

Behavioral: 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)

Other: PANAS
to assess the mood before and after the fMRI and after 4 weeks during a telephone interview
Other Name: Positive And Negative Affect Scales

Other: BDI-II
to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview
Other Name: Beck's depression inventory

Other: 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 Name: Emotion regulation questionnaire

Experimental: fMRI Neurofeedback of right PFC
Study related procedures included: PANAS, BDI-II, ERQ (questionnaires or evaluations)
Procedure: fMRI
collection of functional brain data for 1 hour per day
Other Name: functional magnetic resonance imaging

Behavioral: 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)

Other: PANAS
to assess the mood before and after the fMRI and after 4 weeks during a telephone interview
Other Name: Positive And Negative Affect Scales

Other: BDI-II
to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview
Other Name: Beck's depression inventory

Other: 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 Name: Emotion regulation questionnaire




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes from baseline in brain plasticity [ Time Frame: 2 weeks ]
    fMRI as a measure for brain plasticity before and after neurofeedback

  2. Change in pathology (depression) [ Time Frame: 4 weeks after interventions ]
    BDI-II as a measure of the intensity and quality of depressive symptoms before training and 4 weeks following the intervention

  3. specificity of left or right PFC neurofeedback [ Time Frame: 2 weeks ]
  4. change in resting state brain activation [ Time Frame: 2 weeks ]
    Resting state fMRI as a measure before and after neurofeedback

  5. Change in pathology (mood) [ Time Frame: 4 weeks after interventions ]
    Positive And Negative Affect Scales (PANAS) as a measure of mood before and after the fMRI and after 4 weeks during a telephone interview



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183947


Contacts
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Contact: Klaus Mathiak, Prof MD PhD +49 241 80-89647 kmathiak@ukaachen.de
Contact: Martin Klasen, Dr rer medic +49 241 80-85580 mklasen@ukaachen.de

Locations
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Germany
University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics Not yet recruiting
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Klaus Mathiak, Prof MD PhD University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics

Publications:

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03183947     History of Changes
Other Study ID Numbers: 17-094
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RWTH Aachen University:
fMRI
neurofeedback
emotion regulation
schizophrenia
cognitive reappraisal
depression

Additional relevant MeSH terms:
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Depression
Schizophrenia
Affective Symptoms
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders