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

NCT ID: NCT04348812

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-12-15

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.

Conditions

Anxiety; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tDCS Active

Transcranial direct current stimulation with ABMT

Group Type: EXPERIMENTAL

ABMT

Intervention Type: BEHAVIORAL

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

Transcranial direct current stimulation

Intervention Type: OTHER

Soterix 1X1 tDCS Limited Total Energy (LTE) Stimulator

tDCS sham

Transcranial direct current sham stimulation with ABMT

Group Type: SHAM_COMPARATOR

ABMT

Intervention Type: BEHAVIORAL

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

Interventions

ABMT

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

Intervention Type: BEHAVIORAL

Transcranial direct current stimulation

Soterix 1X1 tDCS Limited Total Energy (LTE) Stimulator

Intervention Type: OTHER

Other Intervention Names

Personal Zen; tDCS

Eligibility Criteria

Inclusion Criteria

• mild - moderate anxiety

Exclusion Criteria

• psychotic disorder
• substance use disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The City College of New York

OTHER

Sponsor Role: collaborator

Hunter College of City University of New York

OTHER

Sponsor Role: lead

Responsible Party

Tracy Dennis

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracy Dennis, PhD

Role: PRINCIPAL_INVESTIGATOR

Hunter College, CUNY

Locations

Hunter College of the City University of New York

New York, New York, United States

Countries

United States

Other Identifiers

334490

Identifier Type: -

Identifier Source: org_study_id