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

NCT05841329 | Completed

• 1 other identifier: SMHC-VR-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acrophobia; Transcranial Direct Current Stimulation

Keywords

virtual reality exposure therapy; acrophobia; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Heights Interpretation Questionnaire(HIQ)

  one day(baseline, after invervention)

• State-Trait Anxiety Inventory Form Y, (STAI-Y)

  one day(baseline, after invervention)

• the Beck Anxiety Inventory(BAI)

  one day(baseline, after invervention)

• Subjective Units of Distress Scale(SUDS)

  assessed every five minutes during intervention

Study Arms (2)

active group

ACTIVE COMPARATOR

receive active tDCS before VRET

Device: tDCS; Behavioral: virtual reality exposure therapy

sham group

SHAM COMPARATOR

receive sham tDCS before VRET

Behavioral: virtual reality exposure therapy

Interventions

tDCS DEVICE

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.

active group

virtual reality exposure therapy BEHAVIORAL

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.

active group; sham group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Acrophobia

Interventions

Transcranial Direct Current Stimulation; Virtual Reality Exposure Therapy

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Desensitization, Psychologic; Behavior Therapy; Psychotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: May 3, 2023
• Study Start: August 6, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: May 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)