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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety
• Intervention / Treatment: Behavioral: ABMT; Other: Transcranial direct current stimulation

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Hunter College of The City University of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• mild - moderate anxiety

Exclusion Criteria:

• psychotic disorder
• substance use disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: tDCS Active; Transcranial direct current stimulation with ABMT	Behavioral: ABMT; mobile attention bias modification training for anxiety, using the app Personal Zen; Other Names: Personal Zen; Other: Transcranial direct current stimulation; Soterix 1X1 tDCS Limited Total Energy (LTE) Stimulator; Other Names: tDCS
SHAM_COMPARATOR: tDCS sham; Transcranial direct current sham stimulation with ABMT	Behavioral: ABMT; mobile attention bias modification training for anxiety, using the app Personal Zen; Other Names: Personal Zen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Collaborators and Investigators

• Sponsor: Hunter College of City University of New York
• Collaborators: The City College of New York
• Investigators: Principal Investigator: Tracy Dennis, PhD, Hunter College, CUNY

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): December 15, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: April 12, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Anxiety, stress
• Other Study ID Numbers: 334490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No