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Completed

NCT Number: NCT04975854

Virtual Reality Exposure Therapy for Acrophobia

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Mental Health

Klecany, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exposure Therapy (Virtual Reality)

Behavioral

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.

Information Session

Other

This includes 20-minute information session about general principles of exposure therapy before the start of the study.

Primary outcomes

  1. Visual Height Intolerance Severity Scale (vHISS)

    Time frame: Immediately Post-Treatment (Controlling for Baseline Score)

    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.

  2. 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.

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

    Time frame: Immediately Post-Treatment (Controlling for Baseline 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.

  4. 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.

  5. The IAPT phobia scale-avoidance

    Time frame: 2-Weeks In-Treatment (Controlling for Baseline 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).

  6. The IAPT phobia scale-avoidance

    Time frame: Immediately Post-Treatment (Controlling for Baseline 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).

  7. 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).

Secondary outcomes

  1. Six-item State-Trait Anxiety Inventory (STAI-6)

    Time frame: 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).

  2. Subjective Units of Distress Scale (SUDS)

    Time frame: 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.

  3. Anxiety Hierarchy

    Time frame: 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.

Other outcomes

  1. The Igroup Presence Questionnaire (IPQ)

    Time frame: Immediately Post-First Session

    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.

  2. Simulator Sickness Questionnaire (SSQ)

    Time frame: Immediately Post-First Session

    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.

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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