Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia

Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia: A Randomized Controlled Trial

The goal of this clinical trial is to examine whether transcranial direct current stimulation(tDCS) can enhance the effect of virtual reality exposure therapy(VRET) in acrophobia in college students with significant fear of heights. The main question it aims to answer are:

• the enhancement of tDCS on the effect of VRET Participants will randomly allocated to tDCS active stimulated group and sham stimulated group and receive VRET.

Study Overview

• Status: Completed
• Conditions: Transcranial Direct Current Stimulation; Acrophobia
• Intervention / Treatment: Device: tDCS; Behavioral: virtual reality exposure therapy

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• the score of the AQ-Anxiety had to be at least 45.45(1SD below the mean of a previous acrophobia sample(Cohen, 1977));
• the participants had the avoidance behaviors in daily life and recognized the fear of height was excessive and unnecessary (the severity of fear of heights not less than 5 points at a scale from 0 to 10).

Exclusion Criteria:

• previous treatment for acrophobia, history or family history of any mental disorder (except for acrophobia), metal parts in the head, medical implants, increased intracranial pressure, pregnancy, current involvement in psycho- or pharmacotherapy, and cardiovascular or neurological diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active group; receive active tDCS before VRET	Device: tDCS; High-definition tDCS (HD-tDCS, 4×1 montage, with 1 anode and 4 cathodes, (Soterix Medical, New York, NY, USA) was applied with battery-driven electrical stimulator (2001&4×1-C3A). The center electrode was anode and placed over FPz (according to the EEG 10-20 system in order to target the medial prefrontal cortex). The reference electrodes were cathodes and placed over AF7, AF8, F3, F4(see fig. 3). Participants were randomized to receive 20 minutes of active(1.5mA) or sham (0 mA) tDCS in a single-blind design. In order to ensure that participants can gradually adapted to the current change, there was a 15-second current rising process before the stimulation and, a 15-second current falling process after the stimulation. For sham tDCS, the device was automatically turned off after current reached 1.5 mA, thus providing 30s of ramping current stimulation, which made it difficult for participants to distinguish which kinds of stimulation they received.; Behavioral: virtual reality exposure therapy; The VRET was adapted on the basis of Öst's single exposure treatment paradigm and conducted by experienced psychotherapists following a standard exposure treatment manual.. An exposure therapy was divided into three parts: psychological education, exposure intervention and summary. Each scene started with a 10-min psychological education followed up with the tDCS stimulation. In exposure trail, participants ought to take an elevator to 100th, observe the environment and look down on the platform. The psychotherapist guided participants to be exposed to the VR environment and helped them experience the process of anxiety decline in the exposure trail.
Sham Comparator: sham group; receive sham tDCS before VRET	Behavioral: virtual reality exposure therapy; The VRET was adapted on the basis of Öst's single exposure treatment paradigm and conducted by experienced psychotherapists following a standard exposure treatment manual.. An exposure therapy was divided into three parts: psychological education, exposure intervention and summary. Each scene started with a 10-min psychological education followed up with the tDCS stimulation. In exposure trail, participants ought to take an elevator to 100th, observe the environment and look down on the platform. The psychotherapist guided participants to be exposed to the VR environment and helped them experience the process of anxiety decline in the exposure trail.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acrophobia Questionnaire(AQ)	It consists of two scales that assess fear (Anxiety, ranging from 0 to 120, involving 20 height situations scored on a seven-point Likert scale; Cronbach' α = 0.80) and avoidance behaviors (Avoidance, ranging from 0 to 40, involving 20 height situations scored on a three-point Likert scale; Cronbach' α = 0.70) of height. Each scale contains 20 scenarios about height situation, such as "Standing next to an open window on the third floor". AQ is widely used to measure fear of heights and has good reliability. Change from Baseline AQ at post-intervention was assessed in the study.	one day(baseline, after invervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heights Interpretation Questionnaire(HIQ)	This scale is a 16-item self-report questionnaire that are rated on a 5-point Likert scale(1 to 5). It was designed to measure height-relevant interpretations. Total scores range from 16 to 80, with higher scores indicating more height-relevant interpretations. Change from Baseline HIQ at post-intervention was assessed in the study.	one day(baseline, after invervention)
State-Trait Anxiety Inventory Form Y, (STAI-Y)	This scale is a 40-item self-report questionnaire that are rated on a 4-point Likert scale(1 to 4). Higher scores indicate more state and trait anxiety. Change from Baseline STAI-Y at post-intervention was assessed in the study.	one day(baseline, after invervention)
the Beck Anxiety Inventory(BAI)	It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms. Change from Baseline BAI at post-intervention was assessed in the study.	one day(baseline, after invervention)
Subjective Units of Distress Scale(SUDS)	This scale is used to assess the level of anxiety with 10 items that are rated from 0-10 point. The higher score indicates more severe current anxiety or distress.	assessed every five minutes during intervention

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2020
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: April 23, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; virtual reality exposure therapy; acrophobia
• Other Study ID Numbers: SMHC-VR-001

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