AnxietyNCT04626713
An Online Home-based Intervention for Anxiety Regulation
A study testing Brain-Computer Interface in people with Anxiety, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
The aim of this project is to evaluate the safety and acceptability of our online, home-based, personalized, neuro-technological mindfulness-based intervention in entraining anxiety regulation and ameliorating anxiety in healthy adults. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Brain-Computer Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 5 Jan 2021to 31 Dec 2022
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 21 and 35 years old (inclusive).
- Literate in English.
- Computer literate and has access to a Windows 10 desktop or laptop
- Beck Anxiety Inventory II total score ≥ 16
Who cannot join
- Diagnosis (as defined by DSM-5) of: any anxiety disorder induced by medication, substance, or another medical condition; obsessive compulsive disorder; bipolar disorder; any psychotic disorder (lifetime); intellectual disability (i.e. IQ < 70); autism spectrum disorder; attention-deficit/ hyperactivity disorder
- History of substance or drug use disorder (as per DSM-5 criteria) within the last 3 months
- Neurological disorders or insults (e.g. epilepsy, cerebrovascular accidents)
- Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites
- Gross visual and hearing impairments
- Irregular heart rhythms or heart problems, severe visual or hearing impairment
- Prior experience with mindfulness-based therapy (e.g. mindfulness-based stress reduction [MBSR], mindfulness-based cognitive therapy [MBCT])
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this project is to evaluate the safety and acceptability of our online, home-based, personalized, neuro-technological mindfulness-based intervention in entraining anxiety regulation and ameliorating anxiety in healthy adults. Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro-/ bio-feedback-based game interface that is driven by an electroencephalography (EEG) algorithm. We hypothesize that the intervention would be safe and acceptable. In exploratory analyses, we further hypothesize that the intervention would help entrain anxiety regulation and ameliorate anxiety in healthy adults. Data will be analyzed quantitatively and qualitatively to inform development of our intervention and future research studies.
Read the detailed description
Anxiety disorders, defined by excess worry, hyperarousal and fear, are amongst the most common class of psychiatric conditions in adults. Large population-based studies on anxiety disorders estimated a lifetime prevalence of 33.7% and a 12-month prevalence between 2.4% and 29.8%. In Singapore, however, studies have only established the prevalence of a limited range or anxiety disorders. In a nationwide, cross-sectional, epidemiological survey, the lifetime prevalence of anxiety disorders, specifically Generalized Anxiety Disorder and Obsessive-Compulsive Disorder, rose from 0.9% and 3.0% respectively in 2010, to 1.6% and 3.6% in 2016. If untreated, anxiety disorders could result in a range of personal and societal costs, such as interpersonal dysfunctions, employment, physical health, social functioning, and frequent primary and acute care visits, resulting in a poor quality of life.
A large proportion of the population experiences subclinical symptoms of anxiety disorders which impede daily functioning and well-being, but most often do not seek professional help or fall below the radar of psychiatric services. Current treatment guidelines recommend pharmacotherapy (i.e. selective serotonin reuptake inhibitors [SSRIs] or venlafaxine) and psychotherapy (i.e. cognitive behavior therapy [CBT]) as first-line treatments for anxiety disorders. Unfortunately, SSRIs are associated with an increased risk of suicide in young adults. Thus, local practices often incorporate more psychological therapies in the treatment of anxiety disorders. However, CBT is labor-intensive and time-consuming - which is incompatible with the demanding lifestyle Singaporeans lead these days. Moreover, therapeutic outcomes are also very much therapist dependent. Due to the fear of stigma that is particularly salient in the local context, individuals with anxiety may be deterred from engaging with therapists. Even if these individuals do receive adequate treatment, existing literature shows that outcomes for recommended treatment modalities are sub-optimal at best, i.e. overall mean remission rate of CBT is 51% while pharmacotherapy is significantly lower. With the low rates of help-seeking behaviors and dismal success rates of existing therapies, novel interventions for anxiety are apposite and vital.
The benefits of mindfulness-based interventions have been extensively researched in anxiety disorders in recent years. Improvements reported across a range of outcomes include enhanced ability to cope with stress, reduced depressive and anxiety symptom severity, as well as improved sleep quality, all of which lead to increased life satisfaction and overall well-being. Not all anxiety regulation strategies are helpful, and mindful emotion regulation presents one promising strategy by cultivating a changing of relationship with one's emotions. Specifically, this strategy facilitates reduced reactivity to emotional stimuli by encouraging one to meet, accept, and detach from one's aversive feelings, thoughts, and ineffective habitual responses. Unfortunately, clinically anxious individuals with no experience in such practices could find it challenging to engage in them as they often require a high degree of individual discipline. Coupled with the fact that sustained practice is crucial to yield the benefits of mindfulness practice, an appealing mode of treatment delivery is necessary. To this end, gamification strategies could be useful: gamification strategies have been shown useful in motivating health-related behaviors through interaction with the immersive interventional programs. Recent preliminary studies have also suggested that neuro-/ biofeedback-based relaxation and mindfulness training is useful for both healthy and anxious individuals.
Accordingly, we have developed an online, home-based, personalized, neuro-technological mindfulness-based intervention and seek to conduct a preliminary study with healthy young adults to evaluate its safety and acceptability. Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro-/ bio-feedback-based game interface that is driven by an electroencephalography (EEG) algorithm. We hypothesize that the intervention would be safe and acceptable. We further hypothesize that the intervention would help entrain anxiety regulation and ameliorate anxiety in healthy adults.
- Conditions
- Anxiety
- Being tested
- Brain-Computer Interface
- Keywords
- Anxiety, Biofeedback, Intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-Computer InterfaceDevice
Brain-computer Interface (BCI) is a direct communication pathway between a human brain and an external device. Electroencephalography (EEG) is the best studied non-invasive interface facilitating such communication. Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro-/ bio-feedback-based game interface that is driven by an EEG algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will undergo a brief interactive psychoeducation session four times a week for two weeks. For each session, participants will wear a commercially available Electroencephalography (EEG) headset and play a downloaded online game for a total of 30 minutes. Participants can feel free to play the game for more than the instructed frequency during their 2-week intervention participation. Receives: Device: Brain-Computer Interface |
| Waitlist control | No intervention | Participants in Waitlist Control will receive no intervention in the first four weeks of the study. After the Intervention group has completed treatment, participants in the Waitlist Control will then undergo the same intervention as the Intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory II (BAI-II)
21-item questionnaire being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.
Measured: Intervention group: Changes from baseline anxiety symptoms (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline anxiety symptoms (week 1) to pre-intervention (week 4) and post-intervention (week 7).
State-trait Anxiety Inventory (STAI)
4-point Likert scale and consisting of 40 questions measuring two types of anxiety - state and trait anxiety.
Measured: Intervention group: Changes from baseline anxiety symptoms (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline anxiety symptoms (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Usability questionnaire (System usability questionnaire)
Participants will rate their agreeableness on 10 statements regarding their satisfaction and ease of use of the training components on a 5-point Likert scale. Participants will also answer three qualitative questions regarding their satisfaction and ease of use.
Measured: Intervention group: Week 4 (post-intervention).
IT Anxiety Scale (ITAS)
7-point Likert scale and consisting of 12 statements measuring participants' anxiety towards information and communication technologies.
Measured: Intervention group: Week 4 (post-intervention).
Usability questionnaire (System usability questionnaire)
Participants will rate their agreeableness on 10 statements regarding their satisfaction and ease of use of the training components on a 5-point Likert scale. Participants will also answer three qualitative questions regarding their satisfaction and ease of use.
Measured: Waitlist control group: Week 7 (post-intervention).
IT Anxiety Scale (ITAS)
7-point Likert scale and consisting of 12 statements measuring participants' anxiety towards information and communication technologies.
Measured: Waitlist control group: Week 7 (post-intervention).
Number of Adverse Events/Serious Adverse Events Reported
The total number and severity rating of all adverse events reported will be collated at the end of the study.
Measured: Throughout the intervention period (2 weeks), which are weeks 2 and 3 for the intervention group.
Number of Adverse Events/Serious Adverse Events Reported
The total number and severity rating of all adverse events reported will be collated at the end of the study.
Measured: Throughout the intervention period (2 weeks), which are weeks 5 and 6 for the waitlist control group.
Secondary outcomes (5)
Pittsburg Sleep Quality Index (PSQI)
19-item questionnaire assessing sleep quality over a 1-month time interval.
Measured: Intervention group: Changes from baseline sleep quality (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline sleep quality (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Insomnia Severity Index (ISI)
7-item instrument assessing the severity of both nighttime and daytime components of insomnia.
Measured: Intervention group: Changes from baseline insomnia symptoms (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Difficulties in Emotion Regulation Scale (DERS-SF)
18-item measure used to identify emotional regulation issues in adults.
Measured: Intervention group: Changes from baseline emotional regulation (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Mindfulness Awareness Attention Scale (MAAS)
15-item questionnaire assessing individual differences in the frequency of mindful states over time.
Measured: Intervention group: Changes from baseline mindfulness (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline mindfulness (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Depression Anxiety Stress Scale (DASS-21)
21-item questionnaire measures the severity of symptoms of depression, anxiety and stress.
Measured: Intervention group: Changes from baseline depression, anxiety and stress (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start5 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Principal investigator, Lee Tih Shih, Duke-NUS Graduate Medical School
- Investigators
- Tih Shih Lee, MD PHD, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626713
- Sponsor's protocol ID
- 2020-220
- Status last verified
- Nov 2021
- First submitted
- 5 Oct 2020
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Home-based Intervention for Anxiety Regulation
- ClinicalTrials.gov ID
- NCT04626713
- Acronym / sponsor ID
- 2020-220
- Conditions
- Anxiety
- Keywords
- Anxiety, Biofeedback, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Nov 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 project is to evaluate the safety and acceptability of our online, home-based, personalized, neuro-technological mindfulness-based intervention in entraining anxiety regulation and ameliorating anxiety in healthy adults. Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro-/ bio-feedback-based game interface that is driven by an electroencephalography (EEG) algorithm. We hypothesize that the intervention would be safe and acceptable. In exploratory analyses, we further hypothesize that the intervention would help entrain anxiety regulation and ameliorate anxiety in healthy adults. Data will be analyzed quantitatively and qualitatively to inform development of our intervention and future research studies.
Detailed description
Anxiety disorders, defined by excess worry, hyperarousal and fear, are amongst the most common class of psychiatric conditions in adults. Large population-based studies on anxiety disorders estimated a lifetime prevalence of 33.7% and a 12-month prevalence between 2.4% and 29.8%. In Singapore, however, studies have only established the prevalence of a limited range or anxiety disorders. In a nationwide, cross-sectional, epidemiological survey, the lifetime prevalence of anxiety disorders, specifically Generalized Anxiety Disorder and Obsessive-Compulsive Disorder, rose from 0.9% and 3.0% respectively in 2010, to 1.6% and 3.6% in 2016. If untreated, anxiety disorders could result in a range of personal and societal costs, such as interpersonal dysfunctions, employment, physical health, social functioning, and frequent primary and acute care visits, resulting in a poor quality of life.
A large proportion of the population experiences subclinical symptoms of anxiety disorders which impede daily functioning and well-being, but most often do not seek professional help or fall below the radar of psychiatric services. Current treatment guidelines recommend pharmacotherapy (i.e. selective serotonin reuptake inhibitors [SSRIs] or venlafaxine) and psychotherapy (i.e. cognitive behavior therapy [CBT]) as first-line treatments for anxiety disorders. Unfortunately, SSRIs are associated with an increased risk of suicide in young adults. Thus, local practices often incorporate more psychological therapies in the treatment of anxiety disorders. However, CBT is labor-intensive and time-consuming - which is incompatible with the demanding lifestyle Singaporeans lead these days. Moreover, therapeutic outcomes are also very much therapist dependent. Due to the fear of stigma that is particularly salient in the local context, individuals with anxiety may be deterred from engaging with therapists. Even if these individuals do receive adequate treatment, existing literature shows that outcomes for recommended treatment modalities are sub-optimal at best, i.e. overall mean remission rate of CBT is 51% while pharmacotherapy is significantly lower. With the low rates of help-seeking behaviors and dismal success rates of existing therapies, novel interventions for anxiety are apposite and vital.
The benefits of mindfulness-based interventions have been extensively researched in anxiety disorders in recent years. Improvements reported across a range of outcomes include enhanced ability to cope with stress, reduced depressive and anxiety symptom severity, as well as improved sleep quality, all of which lead to increased life satisfaction and overall well-being. Not all anxiety regulation strategies are helpful, and mindful emotion regulation presents one promising strategy by cultivating a changing of relationship with one's emotions. Specifically, this strategy facilitates reduced reactivity to emotional stimuli by encouraging one to meet, accept, and detach from one's aversive feelings, thoughts, and ineffective habitual responses. Unfortunately, clinically anxious individuals with no experience in such practices could find it challenging to engage in them as they often require a high degree of individual discipline. Coupled with the fact that sustained practice is crucial to yield the benefits of mindfulness practice, an appealing mode of treatment delivery is necessary. To this end, gamification strategies could be useful: gamification strategies have been shown useful in motivating health-related behaviors through interaction with the immersive interventional programs. Recent preliminary studies have also suggested that neuro-/ biofeedback-based relaxation and mindfulness training is useful for both healthy and anxious individuals.
Accordingly, we have developed an online, home-based, personalized, neuro-technological mindfulness-based intervention and seek to conduct a preliminary study with healthy young adults to evaluate its safety and acceptability. Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro-/ bio-feedback-based game interface that is driven by an electroencephalography (EEG) algorithm. We hypothesize that the intervention would be safe and acceptable. We further hypothesize that the intervention would help entrain anxiety regulation and ameliorate anxiety in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Brain-Computer InterfaceParticipants will undergo a brief interactive psychoeducation session four times a week for two weeks. For each session, participants will wear a commercially available Electroencephalography (EEG) headset and play a downloaded online game for a total of 30 minutes. Participants can feel free to play the game for more than the instructed frequency during their 2-week intervention participation. |
| Waitlist control | No intervention | –Participants in Waitlist Control will receive no intervention in the first four weeks of the study. After the Intervention group has completed treatment, participants in the Waitlist Control will then undergo the same intervention as the Intervention group. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 21 and 35 years old (inclusive).
- Literate in English.
- Computer literate and has access to a Windows 10 desktop or laptop
- Beck Anxiety Inventory II total score ≥ 16
Key exclusion criteria (7 listed)
- Diagnosis (as defined by DSM-5) of: any anxiety disorder induced by medication, substance, or another medical condition; obsessive compulsive disorder; bipolar disorder; any psychotic disorder (lifetime); intellectual disability (i.e. IQ < 70); autism spectrum disorder; attention-deficit/ hyperactivity disorder
- History of substance or drug use disorder (as per DSM-5 criteria) within the last 3 months
- Neurological disorders or insults (e.g. epilepsy, cerebrovascular accidents)
- Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites
- Gross visual and hearing impairments
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 |
|---|---|---|
| Brain-Computer InterfaceBrain-computer Interface (BCI) is a direct communication pathway between a human brain and an external device. Electroencephalography (EEG) is the best studied non-invasive interface facilitating such communication. Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro-/ bio-feedback-based game interface that is driven by an EEG algorithm. | Device | Intervention |
Primary outcome
Beck Anxiety Inventory II (BAI-II)
Time frame: Intervention group: Changes from baseline anxiety symptoms (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline anxiety symptoms (week 1) to pre-intervention (week 4) and post-intervention (week 7).
21-item questionnaire being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.
State-trait Anxiety Inventory (STAI)
Time frame: Intervention group: Changes from baseline anxiety symptoms (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline anxiety symptoms (week 1) to pre-intervention (week 4) and post-intervention (week 7).
4-point Likert scale and consisting of 40 questions measuring two types of anxiety - state and trait anxiety.
Usability questionnaire (System usability questionnaire)
Time frame: Intervention group: Week 4 (post-intervention).
Participants will rate their agreeableness on 10 statements regarding their satisfaction and ease of use of the training components on a 5-point Likert scale. Participants will also answer three qualitative questions regarding their satisfaction and ease of use.
IT Anxiety Scale (ITAS)
Time frame: Intervention group: Week 4 (post-intervention).
7-point Likert scale and consisting of 12 statements measuring participants' anxiety towards information and communication technologies.
Usability questionnaire (System usability questionnaire)
Time frame: Waitlist control group: Week 7 (post-intervention).
Participants will rate their agreeableness on 10 statements regarding their satisfaction and ease of use of the training components on a 5-point Likert scale. Participants will also answer three qualitative questions regarding their satisfaction and ease of use.
IT Anxiety Scale (ITAS)
Time frame: Waitlist control group: Week 7 (post-intervention).
7-point Likert scale and consisting of 12 statements measuring participants' anxiety towards information and communication technologies.
Number of Adverse Events/Serious Adverse Events Reported
Time frame: Throughout the intervention period (2 weeks), which are weeks 2 and 3 for the intervention group.
The total number and severity rating of all adverse events reported will be collated at the end of the study.
Number of Adverse Events/Serious Adverse Events Reported
Time frame: Throughout the intervention period (2 weeks), which are weeks 5 and 6 for the waitlist control group.
The total number and severity rating of all adverse events reported will be collated at the end of the study.
5 secondary outcomes
Pittsburg Sleep Quality Index (PSQI)
Time frame: Intervention group: Changes from baseline sleep quality (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline sleep quality (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Insomnia Severity Index (ISI)
Time frame: Intervention group: Changes from baseline insomnia symptoms (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Difficulties in Emotion Regulation Scale (DERS-SF)
Time frame: Intervention group: Changes from baseline emotional regulation (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Mindfulness Awareness Attention Scale (MAAS)
Time frame: Intervention group: Changes from baseline mindfulness (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline mindfulness (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Depression Anxiety Stress Scale (DASS-21)
Time frame: Intervention group: Changes from baseline depression, anxiety and stress (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline (week 1) to pre-intervention (week 4) and post-intervention (week 7).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Tih Shih Lee, MD PHD principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-Computer Interface in people with Anxiety, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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 4 inclusion and 7 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 17 Nov 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 Singapore. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory II (BAI-II) (time frame: Intervention group: Changes from baseline anxiety symptoms (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline anxiety symptoms (week 1) to pre-intervention (week 4) and post-intervention (week 7).). The study lists 8 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 17 Nov 2021.