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

NCT04562324 | Unknown DMC

• 1 other identifier: NF-2020-TJAH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder; Healthy

Outcome Measures

Primary Outcomes (2)

• The change of scores in Hamilton Anxiety Rating Scale (HAMD) from baseline to week 2.

  The main objective is to explore whether NF add on medicine will improve the anxiety symptoms after 2 weeks of treatment, and investigators assess the scale at baseline and week 1, 2. Hamilton Anxiety Rating Scale (HAMD) items was used to evaluate the severity of symptoms of anxiety. A total score of more than 29 may indicate severe anxiety symptoms; A score above 14 may be mild to moderate anxiety; If the score is less than 7, the patient has no symptoms of anxiety. The higher the total score of the scale, the more severe the anxiety symptoms.

  baseline, Week 1, week 2

• The change of scores in GAD-7 from baseline to week 2.

  The main objective is to explore whether NF add on medicine will improve the anxiety symptoms after 2 weeks of treatment, and investigators assess the scale at baseline and week 1, 2. GAD-7 items were used to evaluate the severity of symptoms of anxiety. A total score of more than 15 may indicate severe anxiety symptoms; A score above 5 may be mild to moderate anxiety; If the score is less than 4, the patient has no symptoms of anxiety. The higher the total score of the scale, the more severe the anxiety symptoms.

  baseline, Week 1, week 2

Secondary Outcomes (9)

• The change of scores in the State-Trait Anxiety Inventory (STAI) from baseline to week 2.

  baseline, Week 1, week 2

• The change of scores in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 2.

  baseline, Week 1, week2

• The change of scores in Insomnia Severity Index (ISI) from baseline to week 2.

  baseline, Week 1, week 2

• The change of scores in Mindful Attention Awareness Scale, MAAS) from baseline to week 2.

  baseline, Week 1, week 2

• The changes of levels of biomarkers in peripheral blood from baseline to week 2

  baseline, week 2

Study Arms (4)

Experimental:

EXPERIMENTAL

NF group participants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks combine a selective serotonin reuptake inhibitor (SSRI) or a serotonin or norepinephrine reuptake inhibitors (SNRI) or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics

Drug: SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics; Device: Neurofeedback system

Healthy Experimental:

EXPERIMENTAL

Participants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks

Device: Neurofeedback system

Healthy Sham Comparator

SHAM COMPARATOR

Sham group participants receive 24 min NF sessions with pseudo-random numbers, 2-3 days per week, for 2 weeks

Device: Neurofeedback system

Sham Comparator

SHAM COMPARATOR

Sham Comparator: Sham group participants receive 24 min NF sessions with pseudo-random numbers, 2-3 days per week, for 2 weeks combine a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitors (SNRI), benzodiazepines, tricyclic antidepressants, other antidepressants, antipsychotics, other sedative-hypnotics

Drug: SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics; Device: Neurofeedback system

Interventions

SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics DRUG

Medications to relieve anxiety

Experimental:; Sham Comparator

Neurofeedback system DEVICE

EEG-neurofeedback is an operant conditioning procedure in which people learn to improve the brain's functional activity and used as a way to effect long-term change in abnormal brain activity thus alter corresponding cognitive function. In addition, its potential to be used to elucidate the mechanisms underlying psychopathology by evaluating the subjective effect of the modulation of specific brain areas has become apparent. Participants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks

Experimental:; Healthy Experimental:; Healthy Sham Comparator; Sham Comparator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Benzodiazepines; Antidepressive Agents, Tricyclic; Antipsychotic Agents

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antidepressive Agents; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Tranquilizing Agents; Central Nervous System Depressants

Central Study Contacts

Jie Li, DOCTOR

CONTACT

022-88188006; tjlijie3827@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: September 24, 2020
• Study Start: September 10, 2019
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2023
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

CN (1)