Virtual Reality Exposure Therapy for Acrophobia
Primary Purpose
Specific Phobia, Acrophobia, Fear of Heights
Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Exposure Therapy (Virtual Reality)
Information Session
Sponsored by
About this trial
This is an interventional treatment trial for Specific Phobia focused on measuring virtual reality exposure therapy, specific phobia, acrophobia
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)
Sites / Locations
- National Institute of Mental HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Virtual Reality Exposure
Control
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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).
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).
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).
Secondary Outcome Measures
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).
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.
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.
Full Information
NCT ID
NCT04975854
First Posted
July 12, 2021
Last Updated
July 22, 2021
Sponsor
National Institute of Mental Health, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT04975854
Brief Title
Virtual Reality Exposure Therapy for Acrophobia
Official Title
Virtual Reality Exposure Therapy Versus No Treatment for Acrophobia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 13, 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Mental Health, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia, Acrophobia, Fear of Heights, Anxiety Disorders
Keywords
virtual reality exposure therapy, specific phobia, acrophobia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Exposure
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure Therapy (Virtual Reality)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Information Session
Intervention Description
This includes 20-minute information session about general principles of exposure therapy before the start of the study.
Primary Outcome Measure Information:
Title
Visual Height Intolerance Severity Scale (vHISS)
Description
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.
Time Frame
Immediately Post-Treatment (Controlling for Baseline Score)
Title
Visual Height Intolerance Severity Scale (vHISS)
Description
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.
Time Frame
2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
Title
Severity Measure for Specific Phobia-Adult (SMSP-A)
Description
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.
Time Frame
Immediately Post-Treatment (Controlling for Baseline Score)
Title
Severity Measure for Specific Phobia-Adult (SMSP-A)
Description
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.
Time Frame
2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
Title
The IAPT phobia scale-avoidance
Description
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).
Time Frame
2-Weeks In-Treatment (Controlling for Baseline Score)
Title
The IAPT phobia scale-avoidance
Description
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).
Time Frame
Immediately Post-Treatment (Controlling for Baseline Score)
Title
The IAPT phobia scale-avoidance
Description
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).
Time Frame
2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
Secondary Outcome Measure Information:
Title
Six-item State-Trait Anxiety Inventory (STAI-6)
Description
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).
Time Frame
Immediately Post-Sessions
Title
Subjective Units of Distress Scale (SUDS)
Description
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.
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).
Title
Anxiety Hierarchy
Description
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.
Time Frame
Immediately Post-Treatment (Controlling for Baseline Score)
Other Pre-specified Outcome Measures:
Title
The Igroup Presence Questionnaire (IPQ)
Description
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.
Time Frame
Immediately Post-First Session
Title
Simulator Sickness Questionnaire (SSQ)
Description
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.
Time Frame
Immediately Post-First Session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iveta Fajnerova
Phone
00420608501034
Email
iveta.fajnerova@nudz.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Francova
Email
anna.francova@nudz.cz
Facility Information:
Facility Name
National Institute of Mental Health
City
Klecany
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iveta Fajnerova
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD (primary outcome measures) that underlie results in a publication.
IPD Sharing Time Frame
IPD will be shared starting 6 month after the publication.
IPD Sharing Access Criteria
Data access requests will be reviewed using an online form. Requestors will be required to sign a data access agreement.
Learn more about this trial
Virtual Reality Exposure Therapy for Acrophobia
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