Virtual Reality Exposure Therapy for Acrophobia

Not Applicable

Completed

• Conditions: Anxiety Disorders; Fear of Heights; Acrophobia; Specific Phobia
• Interventions: Behavioral: Exposure Therapy (Virtual Reality); Other: Information Session

• Registration Number: NCT04975854
• Lead Sponsor: National Institute of Mental Health, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-12
• Study Start: 2021-07-13
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-26
• Primary Completion: 2022-06-17
• Study Completion: 2022-06-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Exposure	Information Session	Participants complete three 30-40-minute sessions of exposure administered via a virtual reality headset. The exposure involve exposure to various heights and height cues in the virtual city environment. Experimental group also attends 20-minute online information session (prerecorded video).
Control	Information Session	Control group attends a single 20-minute information session (prerecorded video) about general principles of exposure therapy and anxiety before the start of the study, but receives no exposure-based intervention.
Virtual Reality Exposure	Exposure Therapy (Virtual Reality)	Participants complete three 30-40-minute sessions of exposure administered via a virtual reality headset. The exposure involve exposure to various heights and height cues in the virtual city environment. Experimental group also attends 20-minute online information session (prerecorded video).

Primary Outcome Measures

Name	Time	Method
The IAPT phobia scale-avoidance	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)	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)	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 Outcome Measures

Name	Time	Method
Six-item State-Trait Anxiety Inventory (STAI-6)	Immediately Post-Sessions	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).
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).	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.
Anxiety Hierarchy	Immediately Post-Treatment (Controlling for Baseline Score)	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.

Trial Locations

Locations (1)

National Institute of Mental Health; 🇨🇿 Klecany, Czechia