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

NCT04348812 | Completed Phase 1

• 1 other identifier: 334490
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Stress

Keywords

Anxiety, stress

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  Day 1

Study Arms (2)

tDCS Active

EXPERIMENTAL

Transcranial direct current stimulation with ABMT

Behavioral: ABMT; Other: Transcranial direct current stimulation

tDCS sham

SHAM COMPARATOR

Transcranial direct current sham stimulation with ABMT

Behavioral: ABMT

Interventions

ABMT BEHAVIORAL

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

Also known as: Personal Zen

tDCS Active; tDCS sham

Transcranial direct current stimulation OTHER

Soterix 1X1 tDCS Limited Total Energy (LTE) Stimulator

Also known as: tDCS

tDCS Active

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• mild - moderate anxiety

You may not qualify if:

• psychotic disorder
• substance use disorder

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• The City College of New York: collaborator

Study Sites (1)

Hunter College of the City University of New York

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Tracy Dennis, PhD

  Hunter College, CUNY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: All participants received active behavioral intervention combined with either active brain stimulation or sham stimulation control

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 16, 2020
• Study Start: February 1, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)