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Clinical Trials/NCT05841329
NCT05841329CompletedNot Applicable

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

Shanghai Mental Health Center1 site in 1 country64 target enrollmentStarted: August 6, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
1
Primary Endpoint
Acrophobia Questionnaire(AQ)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Acrophobia Questionnaire(AQ)

Time Frame: one day(baseline, after invervention)

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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