Virtual Reality Exposure Therapy for Acrophobia

Sponsor
National Institute of Mental Health, Czech Republic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04975854
Collaborator
(none)
50
1
2
10.6
4.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exposure Therapy (Virtual Reality)
  • Other: Information Session
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Virtual Reality Exposure Therapy Versus No Treatment for Acrophobia: A Randomized Controlled Trial
Anticipated Study Start Date :
Jul 13, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality Exposure

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)
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.

Other: Control

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

Outcome Measures

Primary Outcome Measures

  1. Visual Height Intolerance Severity Scale (vHISS) [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) [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) [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) [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 [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 [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 [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 Outcome Measures

  1. 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).

  2. 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.

  3. 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.

Other Outcome Measures

  1. The Igroup Presence Questionnaire (IPQ) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute of Mental Health Klecany Czechia

Sponsors and Collaborators

  • National Institute of Mental Health, Czech Republic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Iveta Fajnerová, senior researcher, National Institute of Mental Health, Czech Republic
ClinicalTrials.gov Identifier:
NCT04975854
Other Study ID Numbers:
  • TL03000223-01
First Posted:
Jul 26, 2021
Last Update Posted:
Jul 26, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Iveta Fajnerová, senior researcher, National Institute of Mental Health, Czech Republic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2021