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Clinical Trials/NCT04348812
NCT04348812
Completed
Phase 1

Transcranial Direct Current Stimulation (tDCS) Augments the Effects of Gamified, Mobile Attention Bias Modification

Hunter College of City University of New York1 site in 1 country38 target enrollmentFebruary 1, 2019
ConditionsAnxietyStress

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Anxiety
Sponsor
Hunter College of City University of New York
Enrollment
38
Locations
1
Primary Endpoint
Self-reported subjective state anxiety
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
December 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Hunter College of City University of New York
Responsible Party
Principal Investigator
Principal Investigator

Tracy Dennis

Primary Investigator

Hunter College of City University of New York

Eligibility Criteria

Inclusion Criteria

  • mild - moderate anxiety

Exclusion Criteria

  • psychotic disorder
  • substance use disorder

Outcomes

Primary Outcomes

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

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)

Secondary Outcomes

  • Magnitude of respiratory sinus arrhythmia, or variability in heart rate due to respiration rate(Day 1)

Study Sites (1)

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