An interventional study of Exposure Therapy (Virtual Reality) and Information Session in Specific Phobia, Acrophobia and Fear of Heights, sponsored by National Institute of Mental Health, Czech Republic. Completed at 1 site in Czechia. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by National Institute of Mental Health, Czech Republic · Not applicable, Interventional, and Treatment
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.
5,113 studies on the registry are indexed under Anxiety Disorders; 1,418 are open to participants now.
This study's enrollment of 43 is below the median of 80 across 4,380 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →National Institute of Mental Health, Czech Republic is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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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).
Behavioral: Exposure Therapy (Virtual Reality) · Other: 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.
Other: Information Session
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.
This includes 20-minute information session about general principles of exposure therapy before the start of the study.
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.
Time frame: Immediately Post-Treatment (Controlling for Baseline Score)
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.
Time frame: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
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.
Time frame: Immediately Post-Treatment (Controlling for Baseline Score)
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.
Time frame: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
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).
Time frame: 2-Weeks In-Treatment (Controlling for Baseline Score)
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).
Time frame: Immediately Post-Treatment (Controlling for Baseline Score)
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).
Time frame: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
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).
Time frame: Immediately Post-Sessions
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.
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).
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.
Time frame: Immediately Post-Treatment (Controlling for Baseline Score)
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.
Time frame: Immediately Post-First Session
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.
Time frame: Immediately Post-First Session
Plan to share: Yes — IPD (primary outcome measures) that underlie results in a publication.
Supporting information: Study protocol
Time frame: IPD will be shared starting 6 month after the publication.
Access criteria: Data access requests will be reviewed using an online form. Requestors will be required to sign a data access agreement.
Ran from Jul 2021 to primary completion in Jun 2022, 11 months.
Of 2,759 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 11 months is close to that.
Counting every sponsor, half of 2,829 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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National Institute of Mental Health, Czech Republic