Efficacy of Electroencephalography (EEG) Neurofeedback (NF) for the Treatment of Anxiety Disorder

  • STATUS
    Recruiting
  • End date
    Nov 27, 2023
  • participants needed
    60
  • sponsor
    Tianjin Anding Hospital
Updated on 27 October 2021
Accepts healthy volunteers

Summary

The aim of this study is to assess the efficacy of electroencephalography (EEG) neurofeedback (NF) as an Add-on Treatment for the Anxiety disorder. Meanwhile, evaluate the effect of EEG-NF on cognitive function of Anxiety patients. Furthermore, the investigators will examine the changes in cortisol, gut microbiome and some biomarkers. The hypothesis of this study is that EEG-NF alleviate the anxiety symptoms and improve the cognitive function of Anxiety disorder patients with regulating attention response.

Description

This is a randomized, double-blind, sham-controlled study using electroencephalography (EEG) neurofeedback (NF) for 2-week treatment. Participants were randomly assigned 1:1 to NF group or sham-control group. The NF group performed six NF sessions every other day in about two weeks. The feedback value of the NF group was about SMR band, while in the control group was pseudo-random numbers. Apart from studying the effects of EEG-NF on severity of anxiety and cognitive function, the secondary outcomes are to examine biomarkers related to inflammatory activity. Scale assessments are performed before the initiation of treatment, week 1, week 2. The Digit Span test, Go/No-Go task Collection of blood, excrement and saliva takes place at two time points, at the baseline, week 2.

Details
Condition Generalized Anxiety Disorder (GAD), Anxiety Disorders, healthy, anxiety disorder, ANXIETY NEUROSIS, Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Disorders (Pediatric)
Treatment SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics, Neurofeedback system
Clinical Study IdentifierNCT04562324
SponsorTianjin Anding Hospital
Last Modified on27 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

a current episode of Anxiety diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
age between 18 and 50 years
a total score of HAMD 14 GAD-7 5
Participants are compliant with treatment according to the judgement of the treating clinician
Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised

Exclusion Criteria

History of alcohol or drug abuse
Severe somatic diseases including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma
Use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial
Use of immunosuppressive medication such as oral steroid hormones Women in pregnancy or lactation period
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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