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

December 6, 2019 updated by: RWTH Aachen University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Positive And Negative Affect Scales
Other: BDI-II
to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview
Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Positive And Negative Affect Scales
Other: BDI-II
to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview
Other Names:
  • 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 Names:
  • Emotion regulation questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in brain plasticity
Time Frame: 2 weeks
fMRI as a measure for brain plasticity before and after neurofeedback
2 weeks
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
4 weeks after interventions
specificity of left or right PFC neurofeedback
Time Frame: 2 weeks
2 weeks
change in resting state brain activation
Time Frame: 2 weeks
Resting state fMRI as a measure before and after neurofeedback
2 weeks
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
4 weeks after interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Klaus Mathiak, Prof MD PhD, University Hospital RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2017

Primary Completion (Actual)

December 6, 2019

Study Completion (Actual)

December 6, 2019

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-094

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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