Clinical trial NCT04348812: Transcranial Direct Current Stimulation (tDCS) Augments the Effects of Gamified, Mobile Attention Bias Modification
Official title: Transcranial Direct Current Stimulation (tDCS) Augments the Effects of Gamified, Mobile Attention Bias Modification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anxiety
Stress
Keywords: Anxiety, stress
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: The City College of New York
First posted: 2020-04-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: All participants received active behavioral intervention combined with either active brain stimulation or sham stimulation control
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* mild - moderate anxiety

Exclusion Criteria:

* psychotic disorder
* substance use disorder

Primary outcomes:
measure: Self-reported negative mood symptoms
timeFrame: Day 1
measure: Self-reported subjective state anxiety
timeFrame: Day 1
measure: Threat bias, or dsyregulated attention towards threat, measured via computer assay
timeFrame: Day 1
Secondary outcomes:
measure: Magnitude of respiratory sinus arrhythmia, or variability in heart rate due to respiration rate
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College of the City University of New York
state: New York
Study officials:
affiliation: Hunter College, CUNY
name: Tracy Dennis, PhD
role: PRINCIPAL_INVESTIGATOR
References: