Back to resultsEfficacy of Electroencephalography (EEG) Neurofeedback (NF) for the Treatment of Anxiety Disorder
Primary Purpose
Anxiety Disorder, Healthy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics
Neurofeedback system
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder
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
Sites / Locations
- Tianjin Anding HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Sham Comparator
Sham Comparator
Arm Label
Experimental:
Healthy Experimental:
Healthy Sham Comparator
Sham Comparator
Arm Description
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
Participants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks
Sham group participants receive 24 min NF sessions with pseudo-random numbers, 2-3 days per week, for 2 weeks
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
The change of scores in the State-Trait Anxiety Inventory (STAI) 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. State-Trait Anxiety Inventory (STAI) items was used to evaluate the severity of symptoms of anxiety. The total score of STAI ranged from 20 to 80. The higher the score, the worse the severity of symptoms of anxiety.
The change of scores in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 2.
The aim is to investigate whether NF training in addition to regular treatment with medicine will improve the sleep quality as measured with Pittsburgh Sleep Quality Index (PSQI) after 2 weeks of treatment compared to sham-group, and investigators assess the scale at baseline, week1and week 2. PSQI was used to evaluate the sleep quality of the subjects in the latest month. The total score of PSQI ranged from 0 to 21. The higher the score, the worse the sleep quality.
The change of scores in Insomnia Severity Index (ISI) from baseline to week 2.
The aim is to investigate whether NF training in addition to regular treatment with medicine will improve the sleep quality as measured with Insomnia Severity Index (ISI) after 2 weeks of treatment compared to sham-group, and investigators assess the scale at baseline, week1and week 2. The ISI scale was used to evaluate the severity of insomnia. The higher the score, the more severe the insomnia
The change of scores in Mindful Attention Awareness Scale, MAAS) from baseline to week 2.
The aim is to investigate whether NF training in addition to regular treatment with medicine will improve the level of mental resilience, attention and consciousness as measured with Mindful Attention Awareness Scale, MAAS) after 2 weeks of treatment compared to sham-group, and investigators assess the scale at baseline, week1and week 2. The MAAS scale evaluates assess the level of mental resilience. The higher the score, the higher the participant's level of mindfulness.
The changes of levels of biomarkers in peripheral blood from baseline to week 2
The aim is to investigate the change of cortisol level of saliva and intestinal flora as active stimuli in addition to regular treatment with medicine after 2 weeks of treatment compared to sham group, and investigators collect the specimens at baseline and week 2.
Saliva collection tube to collect saliva, collect naturally discharged saliva in a clean test tube (at least 2ml). Saliva was centrifuged under 1500rpm for 15 minutes and the filtrate was cryopreserved at-80 C. the saliva was analyzed by ELISA kit.
Fecal collection: a) intercept the middle part of the sample with a sterile toothpick or fecal sampler (the surface of feces contains exfoliated cells of intestinal mucosa; the outside is easy to be contaminated, and some bacterial DNA begins to degrade after contact with air), take about the size of peanuts and put them into aseptic 2.0mL centrifuge tubes, 3-5 tubes for each sample are taken for backup#and then put into-80°C cryopreservation after sub-packaging.
Adverse events from baseline to week 2
2 The aim is to evaluate the adverse effects during the treatment.
The change of reaction time in Go/No-Go task from baseline to week 2.
The aim is to investigate whether NF training in addition to regular treatment with medicine will improve attention as measured with Go/No-Go task after 2 weeks of treatment compared to sham-group, and investigators assess the scale at baseline and week 2. The Go/No-Go task scale evaluates assess the level of attention. The shorter the reaction time, the higher the level of attention.
The accuracy in the Digit Span test (DSP) from baseline to week 2.
The aim is to investigate whether NF training in addition to regular treatment with medicine will improve short-term memory and working memory as measured with the Digit Span test (DSP) after 2 weeks of treatment compared to sham-group, and investigators assess the scale at baseline and week 2. The Digit Span test (DSP) scale evaluates assess short-term memory and working memory. The higher the accuracy, the better the level of memory.
The change of scores in Self-Rating Anxiety Scale (SAS) from baseline to week 2.
The main objective is to explore whether NF will improve the anxiety symptoms after 2 weeks of treatment, and investigators assess the scale at baseline and week 2. Self-Rating Anxiety Scale (SAS)items was used to evaluate the severity of symptoms of anxiety. A total score of more than 56 may indicate severe anxiety symptoms; A score above 40 may be mild to moderate anxiety; If the score is less than 20, the patient has no symptoms of anxiety. The higher the total score of the scale, the more severe the anxiety symptoms.
Full Information
NCT ID
NCT04562324
First Posted
September 19, 2020
Last Updated
October 17, 2021
Sponsor
Tianjin Anding Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04562324
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Anding Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental:
Arm Type
Experimental
Arm Description
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
Arm Title
Healthy Experimental:
Arm Type
Experimental
Arm Description
Participants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks
Arm Title
Healthy Sham Comparator
Arm Type
Sham Comparator
Arm Description
Sham group participants receive 24 min NF sessions with pseudo-random numbers, 2-3 days per week, for 2 weeks
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics
Intervention Description
Medications to relieve anxiety
Intervention Type
Device
Intervention Name(s)
Neurofeedback system
Intervention Description
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
Primary Outcome Measure Information:
Title
The change of scores in Hamilton Anxiety Rating Scale (HAMD) from baseline to week 2.
Description
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.
Time Frame
baseline, Week 1, week 2
Title
The change of scores in GAD-7 from baseline to week 2.
Description
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.
Time Frame
baseline, Week 1, week 2
Secondary Outcome Measure Information:
Title
The change of scores in the State-Trait Anxiety Inventory (STAI) from baseline to week 2.
Description
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. State-Trait Anxiety Inventory (STAI) items was used to evaluate the severity of symptoms of anxiety. The total score of STAI ranged from 20 to 80. The higher the score, the worse the severity of symptoms of anxiety.
Time Frame
baseline, Week 1, week 2
Title
The change of scores in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 2.
Description
The aim is to investigate whether NF training in addition to regular treatment with medicine will improve the sleep quality as measured with Pittsburgh Sleep Quality Index (PSQI) after 2 weeks of treatment compared to sham-group, and investigators assess the scale at baseline, week1and week 2. PSQI was used to evaluate the sleep quality of the subjects in the latest month. The total score of PSQI ranged from 0 to 21. The higher the score, the worse the sleep quality.
Time Frame
baseline, Week 1, week2
Title
The change of scores in Insomnia Severity Index (ISI) from baseline to week 2.
Description
The aim is to investigate whether NF training in addition to regular treatment with medicine will improve the sleep quality as measured with Insomnia Severity Index (ISI) after 2 weeks of treatment compared to sham-group, and investigators assess the scale at baseline, week1and week 2. The ISI scale was used to evaluate the severity of insomnia. The higher the score, the more severe the insomnia
Time Frame
baseline, Week 1, week 2
Title
The change of scores in Mindful Attention Awareness Scale, MAAS) from baseline to week 2.
Description
The aim is to investigate whether NF training in addition to regular treatment with medicine will improve the level of mental resilience, attention and consciousness as measured with Mindful Attention Awareness Scale, MAAS) after 2 weeks of treatment compared to sham-group, and investigators assess the scale at baseline, week1and week 2. The MAAS scale evaluates assess the level of mental resilience. The higher the score, the higher the participant's level of mindfulness.
Time Frame
baseline, Week 1, week 2
Title
The changes of levels of biomarkers in peripheral blood from baseline to week 2
Description
The aim is to investigate the change of cortisol level of saliva and intestinal flora as active stimuli in addition to regular treatment with medicine after 2 weeks of treatment compared to sham group, and investigators collect the specimens at baseline and week 2.
Saliva collection tube to collect saliva, collect naturally discharged saliva in a clean test tube (at least 2ml). Saliva was centrifuged under 1500rpm for 15 minutes and the filtrate was cryopreserved at-80 C. the saliva was analyzed by ELISA kit.
Fecal collection: a) intercept the middle part of the sample with a sterile toothpick or fecal sampler (the surface of feces contains exfoliated cells of intestinal mucosa; the outside is easy to be contaminated, and some bacterial DNA begins to degrade after contact with air), take about the size of peanuts and put them into aseptic 2.0mL centrifuge tubes, 3-5 tubes for each sample are taken for backup#and then put into-80°C cryopreservation after sub-packaging.
Time Frame
baseline, week 2
Title
Adverse events from baseline to week 2
Description
2 The aim is to evaluate the adverse effects during the treatment.
Time Frame
week 1, week 2
Title
The change of reaction time in Go/No-Go task from baseline to week 2.
Description
The aim is to investigate whether NF training in addition to regular treatment with medicine will improve attention as measured with Go/No-Go task after 2 weeks of treatment compared to sham-group, and investigators assess the scale at baseline and week 2. The Go/No-Go task scale evaluates assess the level of attention. The shorter the reaction time, the higher the level of attention.
Time Frame
baseline, week 2
Title
The accuracy in the Digit Span test (DSP) from baseline to week 2.
Description
The aim is to investigate whether NF training in addition to regular treatment with medicine will improve short-term memory and working memory as measured with the Digit Span test (DSP) after 2 weeks of treatment compared to sham-group, and investigators assess the scale at baseline and week 2. The Digit Span test (DSP) scale evaluates assess short-term memory and working memory. The higher the accuracy, the better the level of memory.
Time Frame
baseline, week 2
Title
The change of scores in Self-Rating Anxiety Scale (SAS) from baseline to week 2.
Description
The main objective is to explore whether NF will improve the anxiety symptoms after 2 weeks of treatment, and investigators assess the scale at baseline and week 2. Self-Rating Anxiety Scale (SAS)items was used to evaluate the severity of symptoms of anxiety. A total score of more than 56 may indicate severe anxiety symptoms; A score above 40 may be mild to moderate anxiety; If the score is less than 20, the patient has no symptoms of anxiety. The higher the total score of the scale, the more severe the anxiety symptoms.
Time Frame
baseline, week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Li, DOCTOR
Phone
022-88188006
Email
tjlijie3827@163.com
Facility Information:
Facility Name
Tianjin Anding Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Li, Doctor
Phone
+86 022 88188006
Email
tjlijie3827@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Electroencephalography (EEG) Neurofeedback (NF) for the Treatment of Anxiety Disorder
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