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

NCT ID: NCT05841329

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-06
• Study Completion Date: 2021-07-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

active group

receive active tDCS before VRET

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: 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.

virtual reality exposure therapy

Intervention Type: 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.

sham group

receive sham tDCS before VRET

Group Type: SHAM_COMPARATOR

virtual reality exposure therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SMHC-VR-001

Identifier Type: -

Identifier Source: org_study_id