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OpenTrials
Completed

NCT Number: NCT04348812

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hunter College of the City University of New York

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mild - moderate anxiety

Exclusion criteria

  • psychotic disorder
  • substance use disorder

Treatment and study plan

ABMT

Behavioral

mobile attention bias modification training for anxiety, using the app Personal Zen

Other names: Personal Zen

transcranial direct current stimulation

Other

Soterix 1X1 tDCS Limited Total Energy (LTE) Stimulator

Other names: tDCS

Primary outcomes

  1. 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)

  2. 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).

  3. 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

Secondary outcomes

  1. Magnitude of respiratory sinus arrhythmia, or variability in heart rate due to respiration rate

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Collaborators

  • The City College of New York

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2020
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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