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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03183947
Acronym
APIC-II
Enrollment
81
Registered
2017-06-12
Start date
2017-08-29
Completion date
2019-12-06
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Schizophrenia

Keywords

fMRI, neurofeedback, emotion regulation, schizophrenia, cognitive reappraisal, depression

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.

Interventions

PROCEDUREfMRI

collection of functional brain data for 1 hour per day

BEHAVIORALNeurofeedback

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)

OTHERPANAS

to assess the mood before and after the fMRI and after 4 weeks during a telephone interview

OTHERBDI-II

to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview

OTHERERQ

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

Sponsors

RWTH Aachen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
change in self-control over neuronal activity in PFC1 weekfMRI-BCI as a measure before and after the regulation of the brain activity

Secondary

MeasureTime frameDescription
Changes from baseline in brain plasticity2 weeksfMRI as a measure for brain plasticity before and after neurofeedback
Change in pathology (depression)4 weeks after interventionsBDI-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 neurofeedback2 weeks
change in resting state brain activation2 weeksResting state fMRI as a measure before and after neurofeedback
Change in pathology (mood)4 weeks after interventionsPositive And Negative Affect Scales (PANAS) as a measure of mood before and after the fMRI and after 4 weeks during a telephone interview

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026