- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06906770
Virtual Reality-based Eye Movement Desensitisation and Reprocessing Therapy for Specific Phobias
The goal of this clinical trial is to study the effectiveness of a virtual reality-based eye movement desensitization and reprocessing (EMDR) application in treating phobia. It will also learn about the feasibility and safety of the application for independent use.
The main questions it aims to answer are:
Does the VR EMDR application reduce distress, improve positive cognitions, and decrease avoidance of specific phobias? Can the application help diminish phobia-related bodily sensations and encourage cognitive shifts toward positive beliefs and greater confidence in confronting previously avoided situations? Can the participants independently administer the treatment with minimum assistance?
Participants will:
Visit the site and take the VR EMDR phobia treatment every day for one week. Report their phobia and simulator sickness symptoms through self-report questionnaires or semi-structured interviews.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Northamptonshire
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Northampton, Northamptonshire, United Kingdom, NN1 5PH
- University of Northampton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have a specific phobia (not necessarily clinically significant)
Exclusion Criteria:
- Diagnosis of mental health disorders
- History of trauma associated with their phobia
- History of panic attacks associated with their phobia
- History of psychosis
- Current self-harm
- Current suicidal ideation
- Regular use of substances that might affect mental state
- Regular use of medications that might affect mental state
- Significant visual impairments
- Severe motion sickness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR EMDR
|
Short form and frequent eye movement desensitization and reprocessing (EMDR) in virtual reality for specific phobia treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Subjective Units of Distress (SUDs)
Time Frame: Recorded 4 times during each VR EMDR session (first being baseline, and the subsequent three were recorded after each eye movement set in desensitisation phrase) across the 5 consecutive intervention days.
|
The Subjective Units of Distress Scale (SUDs) is a self-reported measure of distress experienced by participants during each virtual reality (VR) EMDR session.
Participants will rate their level of distress on a scale from 0 (no distress) to 10 (highest distress).
Outcome is measured by the change in SUD score throughout each session and cumulative change from Day 1 to Day 5.
|
Recorded 4 times during each VR EMDR session (first being baseline, and the subsequent three were recorded after each eye movement set in desensitisation phrase) across the 5 consecutive intervention days.
|
|
Change in Validity of Cognitions (VoC)
Time Frame: Recorded 4 times during each VR EMDR session (first being baseline, and the subsequent three were recorded after each eye movement set in installation phrase) across the 5 consecutive intervention days.
|
The Validity of Cognition (VoC) scale measures the strength of positive cognitions related to the phobic trigger.
Participants will rate how true their preferred positive cognition feels on a scale from 1 (completely false) to 7 (completely true) during each VR EMDR session.
Outcome is measured by change in VoC score throughout each session and cumulative change from Day 1 to Day 5.
|
Recorded 4 times during each VR EMDR session (first being baseline, and the subsequent three were recorded after each eye movement set in installation phrase) across the 5 consecutive intervention days.
|
|
Change in IAPT Phobia Scale Score
Time Frame: Baseline (Day 0, pre-intervention) and post-intervention (Day 5).
|
The Improving Access to Psychological Therapies (IAPT) Phobia Scale assesses the severity of phobic symptoms in terms of avoidance behaviour.
Participants will complete the scale before the intervention (baseline) and immediately after the final session (Day 5).
Outcome is measured by the change in IAPT Phobia Scale score from baseline to Day 5 post-intervention.
Participants achieved remission if they scored below the threshold of 4 in the Improving Access to Psychological Therapies Phobia (IAPT) phobia scale.
|
Baseline (Day 0, pre-intervention) and post-intervention (Day 5).
|
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The Severity Measure for Specific Phobia-Adult
Time Frame: Baseline (Day 0, pre-intervention) and post-intervention (Day 5).
|
The Severity Measure for Specific Phobia-Adult is a 10-item measure that assesses the severity of specific phobia in individuals age 18 and older.
The measure was designed to be completed by an individual upon receiving a diagnosis of specific phobia (or clinically significant specific phobia symptoms) and thereafter, prior to follow-up visits with the clinician.
Each item asks the individual to rate the severity of his or her specific phobia during the past 7 days.
|
Baseline (Day 0, pre-intervention) and post-intervention (Day 5).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simulator Sickness Questionnaire (SSQ) Score Change
Time Frame: Day 1 and Day 5 post-intervention.
|
The Simulator Sickness Questionnaire (SSQ) is used to assess potential side effects of virtual reality exposure, including nausea, oculomotor discomfort, and disorientation.
Participants will complete the SSQ at the end of the first and last intervention days.
Outcome is measured by the change in total SSQ score between Day 1 and Day 5.
|
Day 1 and Day 5 post-intervention.
|
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Participant Adherence
Time Frame: Day 5 post-intervention.
|
Description: Adherence will be assessed based on the number of sessions completed
|
Day 5 post-intervention.
|
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Participant Acceptability
Time Frame: Day 5 post-intervention
|
Description: Acceptability will be evaluated using participant feedback collected at the end of the intervention period.
|
Day 5 post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FHSHEA000372
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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