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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348812
• Other study ID #: 334490
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: April 2020
• Source: Hunter College of City University of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• mild - moderate anxiety

Exclusion Criteria:

• psychotic disorder

• substance use disorder

Related Conditions & MeSH terms

• Anxiety
• Stress

Intervention

Behavioral:
• ABMT
mobile attention bias modification training for anxiety, using the app Personal Zen

Other:
• Transcranial direct current stimulation
Soterix 1X1 tDCS Limited Total Energy (LTE) Stimulator

Locations

Country	Name	City	State
United States	Hunter College of the City University of New York	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hunter College of City University of New York	The City College of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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