Clinical trial NCT04562324: Efficacy of Electroencephalography (EEG) Neurofeedback (NF) for the Treatment of Anxiety Disorder
Official title: Efficacy of Electroencephalography (EEG) Neurofeedback (NF) of Motor Sensory Cortex as an Add-on Treatment for Drug-naïve Anxiety Disorder: A Randomized, Double-blind, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorder
Healthy
Lead sponsor: Tianjin Anding Hospital
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of scores in Hamilton Anxiety Rating Scale (HAMD) from baseline to week 2.
timeFrame: baseline, Week 1, week 2
measure: The change of scores in GAD-7 from baseline to week 2.
timeFrame: baseline, Week 1, week 2
Secondary outcomes:
measure: The change of scores in the State-Trait Anxiety Inventory (STAI) from baseline to week 2.
timeFrame: baseline, Week 1, week 2
measure: The change of scores in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 2.
timeFrame: baseline, Week 1, week2
measure: The change of scores in Insomnia Severity Index (ISI) from baseline to week 2.
timeFrame: baseline, Week 1, week 2
measure: The change of scores in Mindful Attention Awareness Scale, MAAS) from baseline to week 2.
timeFrame: baseline, Week 1, week 2
measure: The changes of levels of biomarkers in peripheral blood from baseline to week 2
timeFrame: baseline, week 2
measure: Adverse events from baseline to week 2
timeFrame: week 1, week 2
measure: The change of reaction time in Go/No-Go task from baseline to week 2.
timeFrame: baseline, week 2
measure: The accuracy in the Digit Span test (DSP) from baseline to week 2.
timeFrame: baseline, week 2
measure: The change of scores in Self-Rating Anxiety Scale (SAS) from baseline to week 2.
timeFrame: baseline, week 2
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Anding Hospital
Study officials:
References: