Virtual Reality Exposure Therapy for Acrophobia

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975854
• Other study ID #: TL03000223-01
• Status: Completed
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: June 17, 2022

Study information

• Verified date: May 2024
• Source: National Institute of Mental Health, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acrophobia
• Anxiety Disorders
• Fear of Heights
• Specific Phobia

Intervention

Behavioral:
• Exposure Therapy (Virtual Reality)
Virtual reality scenarios consists of increasingly intense exposures to phobic stimuli (e.g., looking over railings from various floor levels) with the support of the therapist. The goal of VRET is sufficient reduction in anxiety to allow the patients to expose themselves to heights in everyday situations.

Other:
• Information Session
This includes 20-minute information session about general principles of exposure therapy before the start of the study.

Locations

Country	Name	City	State
Czechia	National Institute of Mental Health	Klecany

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Igroup Presence Questionnaire (IPQ)	The scale includes 3 subscales SP (spatial presence), INV (involvement) and REAL (experienced realism) with score range 0-7. Higher scores indication higher sense of presence. This measure might be positivelly associated with positive outcome.	Immediately Post-First Session
Other	Simulator Sickness Questionnaire (SSQ)	The scale evaluates cybersickness symptoms in three subscales: nausea (N), oculomotor disturbance (O), disorientation (D). Total simulator sickness raw score 0-48 (adjusted total score 0-180). Higher scores on each scale indicatestronger perceptions of the underlying sickness symptoms and aretherefore undesired. This measure might be negatively associated with positive outcome and sense of presence.	Immediately Post-First Session
Primary	Visual Height Intolerance Severity Scale (vHISS)	The vHISS is a 8-item scale assessing the severity of visual height intolerance with additional questions for diagnosing acrophobia. Raw score range from 0 to 13, where 0 = least severely affected and 13 = most severely affected.	Immediately Post-Treatment (Controlling for Baseline Score)
Primary	Visual Height Intolerance Severity Scale (vHISS)	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.	2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
Primary	Severity Measure for Specific Phobia-Adult (SMSP-A)	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.	Immediately Post-Treatment (Controlling for Baseline Score)
Primary	Severity Measure for Specific Phobia-Adult (SMSP-A)	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.	2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
Primary	The IAPT phobia scale-avoidance	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).	2-Weeks In-Treatment (Controlling for Baseline Score)
Primary	The IAPT phobia scale-avoidance	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).	Immediately Post-Treatment (Controlling for Baseline Score)
Primary	The IAPT phobia scale-avoidance	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).	2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
Secondary	Six-item State-Trait Anxiety Inventory (STAI-6)	The 6-item short form of the Spielberger State-Trait Anxiety Inventory (STAI) is used to measure self-reported symptoms of state anxiety with higher score indicating higher anxiety levels (prorated score range 20-80).	Immediately Post-Sessions
Secondary	Subjective Units of Distress Scale (SUDS)	The SUDS is a visual analog scale in which the participant rates his/her anxiety/discomfort based on a range between 0 (no anxiety/discomfort) and 10 (very severe anxiety/discomfort). A SUDS rating will be collected at the end of each segment, reflecting maximum distress experienced during the interaction.	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).
Secondary	Anxiety Hierarchy	The patient is asked to develope a hierarchy of feared situations ranging from most-feared at the top to least-feared at the bottom. Then, he/she rates anticipated fear, anxiety or distress for each item (score 0-100 %, with higher score indicating higher anxiety) - according to how distressing they feel it would be to encounter that situation. The hierarchy is used to guide a process of VRET sessions.	Immediately Post-Treatment (Controlling for Baseline Score)