AnxietyPhase 1NCT04348812
Transcranial Direct Current Stimulation (tDCS) Augments the Effects of Gamified, Mobile Attention Bias Modification
A Phase 1 study testing ABMT and Transcranial direct current stimulation in people with Anxiety and Stress, run by Hunter College of City University of New York at 1 site in United States.
Trial summary
The present study tested whether transcranial direct current stimulation (tDCS) across the prefrontal cortex (PFC), versus sham stimulation, effectively augments the beneficial effects of a gamified attention bias modification training (ABMT) mobile app. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- ABMT and Transcranial direct current stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 15 Dec 2019
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- mild - moderate anxiety
Who cannot join
- psychotic disorder
- substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter College of the City University of New York
New York, New York, 10065
About this study
The present study tested whether transcranial direct current stimulation (tDCS) across the prefrontal cortex (PFC), versus sham stimulation, effectively augments the beneficial effects of a gamified attention bias modification training (ABMT) mobile app.
Read the detailed description
Anxiety-related attentional bias (AB) is the preferential processing of threat observed in clinical and sub-clinical anxiety. Attention bias modification training (ABMT) is a computerized cognitive training technique designed to systematically direct attention away from threat and ameliorate AB, but mixed and null findings have highlighted gaps in our understanding of mechanisms underlying ABMT and how to design the most effective delivery systems. One neuromodulation technique, transcranial direct current stimulation (tDCS) across the prefrontal cortex (PFC) may augment the effects of ABMT by strengthening top-down cognitive control processes, but the evidence base is limited and has not been generalized to current approaches in digital therapeutics, such as mobile applications. The present study tested whether tDCS across the PFC, versus sham stimulation, effectively augments the beneficial effects of a gamified ABMT mobile app. Thirty-eight adults (Mage = 23.92, SD = 4.75; 18 females) evidencing low-to-moderate anxiety symptoms were randomly assigned to active or sham tDCS for 30-minutes while receiving ABMT via a mobile app. Participants reported on potential moderators of ABMT, including life stress and trait anxiety. ECG was recorded during a subsequent stressor to generate respiratory sinus arrhythmia (RSA) suppression as a metric of stress resilience.
- Being tested
- ABMT, Transcranial direct current stimulation
- Keywords
- Anxiety, stress
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABMTBehavioural
Also called Personal Zen
mobile attention bias modification training for anxiety, using the app Personal Zen
Transcranial direct current stimulationOther
Also called tDCS
Soterix 1X1 tDCS Limited Total Energy (LTE) Stimulator
| Study group | Role | What they receive |
|---|---|---|
| tDCS Active | Experimental | Transcranial direct current stimulation with ABMT Receives: Behavioral: ABMT; Other: Transcranial direct current stimulation |
| tDCS sham | Sham comparator | Transcranial direct current sham stimulation with ABMT Receives: Behavioral: ABMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported negative mood symptoms
Self report using the Depression, Anxiety, Stress Scale (DASS); Higher scores mean more severe negative mood/worse outcomes (scores ranging from 0-42)
Measured: Day 1
Self-reported subjective state anxiety
Self report of state anxiety using the State-Trait Anxiety Inventory (STAI); Higher scores mean greater anxiety severity/worse outcomes (scores ranging from 20-80).
Measured: Day 1
Threat bias, or dsyregulated attention towards threat, measured via computer assay
Using the computerized, reaction time-based cognitive assessment task, the "dot probe", biased attention towards or away from threat-relevant information will be assessed based on reaction-time based scoring procedures. Higher scores mean greater bias/worse outcomes
Measured: Day 1
Secondary outcomes (1)
Magnitude of respiratory sinus arrhythmia, or variability in heart rate due to respiration rate
Respiratory sinus arrhythmia (RSA), calculated using mobile electrocardiogram, will be assessed during the Trier Social Stress Task, a standardized behavioral assessment of stress. Higher scores mean greater contribution of respiratory rate to heart rate.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Feb 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- All participants received active behavioral intervention combined with either active brain stimulation or sham stimulation control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- The City College of New York
- Responsible party
- Principal investigator, Tracy Dennis, Hunter College of City University of New York
- Investigators
- Tracy Dennis, PhD, Principal investigator, Hunter College, CUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348812
- Sponsor's protocol ID
- 334490
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) Augments the Effects of Gamified, Mobile Attention Bias Modification
- ClinicalTrials.gov ID
- NCT04348812
- Acronym / sponsor ID
- 334490
- Keywords
- Anxiety, stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- The City College of New York
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 16 Apr 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 present study tested whether transcranial direct current stimulation (tDCS) across the prefrontal cortex (PFC), versus sham stimulation, effectively augments the beneficial effects of a gamified attention bias modification training (ABMT) mobile app.
Detailed description
Anxiety-related attentional bias (AB) is the preferential processing of threat observed in clinical and sub-clinical anxiety. Attention bias modification training (ABMT) is a computerized cognitive training technique designed to systematically direct attention away from threat and ameliorate AB, but mixed and null findings have highlighted gaps in our understanding of mechanisms underlying ABMT and how to design the most effective delivery systems. One neuromodulation technique, transcranial direct current stimulation (tDCS) across the prefrontal cortex (PFC) may augment the effects of ABMT by strengthening top-down cognitive control processes, but the evidence base is limited and has not been generalized to current approaches in digital therapeutics, such as mobile applications. The present study tested whether tDCS across the PFC, versus sham stimulation, effectively augments the beneficial effects of a gamified ABMT mobile app. Thirty-eight adults (Mage = 23.92, SD = 4.75; 18 females) evidencing low-to-moderate anxiety symptoms were randomly assigned to active or sham tDCS for 30-minutes while receiving ABMT via a mobile app. Participants reported on potential moderators of ABMT, including life stress and trait anxiety. ECG was recorded during a subsequent stressor to generate respiratory sinus arrhythmia (RSA) suppression as a metric of stress resilience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants received active behavioral intervention combined with either active brain stimulation or sham stimulation control
| Arm | Type | Receives |
|---|---|---|
| tDCS Active | Experimental | Behavioral: ABMT, Other: Transcranial direct current stimulationTranscranial direct current stimulation with ABMT |
| tDCS sham | Sham comparator | Behavioral: ABMTTranscranial direct current sham stimulation with ABMT |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- mild - moderate anxiety
Key exclusion criteria (2 listed)
- psychotic disorder
- substance use disorder
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 |
|---|---|---|
| ABMTAlso: Personal Zenmobile attention bias modification training for anxiety, using the app Personal Zen | Behavioural | tDCS Active, tDCS sham |
| Transcranial direct current stimulationAlso: tDCSSoterix 1X1 tDCS Limited Total Energy (LTE) Stimulator | Other | tDCS Active |
Primary outcome
Self-reported negative mood symptoms
Time frame: Day 1
Self report using the Depression, Anxiety, Stress Scale (DASS); Higher scores mean more severe negative mood/worse outcomes (scores ranging from 0-42)
Self-reported subjective state anxiety
Time frame: Day 1
Self report of state anxiety using the State-Trait Anxiety Inventory (STAI); Higher scores mean greater anxiety severity/worse outcomes (scores ranging from 20-80).
Threat bias, or dsyregulated attention towards threat, measured via computer assay
Time frame: Day 1
Using the computerized, reaction time-based cognitive assessment task, the "dot probe", biased attention towards or away from threat-relevant information will be assessed based on reaction-time based scoring procedures. Higher scores mean greater bias/worse outcomes
1 secondary outcome
Magnitude of respiratory sinus arrhythmia, or variability in heart rate due to respiration rate
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Tracy Dennis, PhD principal investigator
Hunter College, CUNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABMT and Transcranial direct current stimulation in people with Anxiety and Stress, run by Hunter College of City University of New York at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 17 Apr 2020. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-reported negative mood symptoms (time frame: Day 1). The study lists 3 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 Apr 2020.