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Clinical Trials/NCT04975854
NCT04975854
Completed
N/A

Virtual Reality Exposure Therapy Versus No Treatment for Acrophobia: A Randomized Controlled Trial

National Institute of Mental Health, Czech Republic1 site in 1 country43 target enrollmentJuly 13, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Specific Phobia
Sponsor
National Institute of Mental Health, Czech Republic
Enrollment
43
Locations
1
Primary Endpoint
The IAPT phobia scale-avoidance
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to examine the efficacy of virtual reality exposure therapy (VRET) as a treatment for specific phobia (acrophobia). The study will randomly assign 42 participants with acrophobia to one of two conditions: a) the experimental condition (consisting of 3 sessions of virtual reality exposure) or b) a control condition. Both groups will receive short information session about general principles of exposure therapy before the start of the study. After the end of the study, the waitlist group will be invited to attend the short version (one or two-sessions) of the VRET. Both groups will receive a final follow-up questionnaires 2 months after the last session.

Registry
clinicaltrials.gov
Start Date
July 13, 2021
End Date
June 17, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute of Mental Health, Czech Republic
Responsible Party
Principal Investigator
Principal Investigator

Iveta Fajnerová

senior researcher

National Institute of Mental Health, Czech Republic

Eligibility Criteria

Inclusion Criteria

  • individual meeting ICD-10 criteria for diagnosis of specific phobia
  • fluent in Czech

Exclusion Criteria

  • currently receiving psychological treatment for acrophobia
  • psychotropic medication (unless on stable dosage for the previous 1 month and stabilized for the duration of the study)
  • another severe mental disorder, such as bipolar disorder or psychotic disorder
  • contradictions to using a virtual reality (e.g., epilepsy, balance problems)

Outcomes

Primary Outcomes

The IAPT phobia scale-avoidance

Time Frame: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)

The IAPT phobia scale-avoidance is a single item from the outcome measures administered by the UK National Health Service's IAPT programme (Improving Access to Psychological Therapies). The patient is asked to rate his/her avoidance of heights in daily situations on a scale from 0 (would not avoid it) to 8 (always avoid it).

Visual Height Intolerance Severity Scale (vHISS)

Time Frame: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)

The vHISS is a 8-item scale assessing the severity of visual height intolerance with additional questions for acrophobia.Raw score range from 0 to 13, where 0 = least severely affected and 13 = most severely affected.

Severity Measure for Specific Phobia-Adult (SMSP-A)

Time Frame: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)

SMSP-A is a 10-item scale that assesses the severity of specific phobias in individuals aged 18 and older over the past 7 days. Items are scored on a 5-point Likert scale with item scores of 1-4 respectively indicating mild, moderate, severe and extreme severity of specific phobia related distress.

Secondary Outcomes

  • Six-item State-Trait Anxiety Inventory (STAI-6)(Immediately Post-Sessions)
  • Subjective Units of Distress Scale (SUDS)(Through study completion, an average of 1 months. During In-Sessions: week 1-3 (reported repeatedly during each session in response to presented exposure situations).)
  • Anxiety Hierarchy(Immediately Post-Treatment (Controlling for Baseline Score))

Study Sites (1)

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