Anxiety DisorderNCT04562324
Efficacy of Electroencephalography (EEG) Neurofeedback (NF) for the Treatment of Anxiety Disorder
A study testing SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics and Neurofeedback system in people with Anxiety Disorder and Healthy, run by Tianjin Anding Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder, Healthy
- What is being tested?
- SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics and Neurofeedback system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2019to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Anding Hospital
Tianjin
Jie Li, Doctor, +86 022 88188006, tjlijie3827@163.com
About this study
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
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.
Read the 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.
- Conditions
- Anxiety Disorder, Healthy
- Being tested
- SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics, Neurofeedback system
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnoticsDrug
Medications to relieve anxiety
Neurofeedback systemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics; Device: Neurofeedback system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, Week 1, week 2
Secondary outcomes (9)
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.
Measured: baseline, Week 1, week 2
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.
Measured: baseline, Week 1, week2
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
Measured: baseline, Week 1, week 2
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.
Measured: baseline, Week 1, week 2
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.
Measured: baseline, week 2
Adverse events from baseline to week 2
2 The aim is to evaluate the adverse effects during the treatment.
Measured: week 1, week 2
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.
Measured: baseline, week 2
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.
Measured: baseline, week 2
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.
Measured: baseline, week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start10 Sep 2019
- Primary completionOct 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562324
- Sponsor's protocol ID
- NF-2020-TJAH
- Status last verified
- Oct 2021
- First submitted
- 19 Sep 2020
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04562324
- Acronym / sponsor ID
- NF-2020-TJAH
- Conditions
- Anxiety Disorder, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: | Experimental | Drug: SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics, Device: Neurofeedback systemNF 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 |
| Healthy Experimental: | Experimental | Device: Neurofeedback systemParticipants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks |
| Healthy Sham Comparator | Sham comparator | Device: Neurofeedback systemSham group participants receive 24 min NF sessions with pseudo-random numbers, 2-3 days per week, for 2 weeks |
| Sham Comparator | Sham comparator | Drug: SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics, Device: Neurofeedback systemSham 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnoticsMedications to relieve anxiety | Drug | Experimental:, Sham Comparator |
| Neurofeedback systemEEG-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 | Device | Experimental:, Healthy Experimental:, Healthy Sham Comparator, Sham Comparator |
Primary outcome
The change of scores in Hamilton Anxiety Rating Scale (HAMD) from baseline to week 2.
Time frame: baseline, Week 1, 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.
Time frame: baseline, Week 1, 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.
9 secondary outcomes
The change of scores in the State-Trait Anxiety Inventory (STAI) from baseline to week 2.
Time frame: baseline, Week 1, week 2
The change of scores in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 2.
Time frame: baseline, Week 1, week2
The change of scores in Insomnia Severity Index (ISI) from baseline to week 2.
Time frame: baseline, Week 1, week 2
The change of scores in Mindful Attention Awareness Scale, MAAS) from baseline to week 2.
Time frame: baseline, Week 1, week 2
The changes of levels of biomarkers in peripheral blood from baseline to week 2
Time frame: baseline, week 2
Adverse events from baseline to week 2
Time frame: week 1, week 2
The change of reaction time in Go/No-Go task from baseline to week 2.
Time frame: baseline, week 2
The accuracy in the Digit Span test (DSP) from baseline to week 2.
Time frame: baseline, week 2
The change of scores in Self-Rating Anxiety Scale (SAS) from baseline to week 2.
Time frame: baseline, week 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics and Neurofeedback system in people with Anxiety Disorder and Healthy, run by Tianjin Anding Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, DOCTOR (022-88188006, tjlijie3827@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of scores in Hamilton Anxiety Rating Scale (HAMD) from baseline to week 2. (time frame: baseline, Week 1, week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.