NCT06906770

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

4 days

First QC Date

March 24, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

Eye Movement Desensitization and Reprocessing (EMDR)Virtual Reality

Outcome Measures

Primary Outcomes (4)

  • Change in Subjective Units of Distress (SUDs)

    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)

    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

    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).

  • The Severity Measure for Specific Phobia-Adult

    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 Outcomes (3)

  • Simulator Sickness Questionnaire (SSQ) Score Change

    Day 1 and Day 5 post-intervention.

  • Participant Adherence

    Day 5 post-intervention.

  • Participant Acceptability

    Day 5 post-intervention

Study Arms (1)

VR EMDR

EXPERIMENTAL
Other: Eye movement desensitization and reprocessing phobia treatment in virtual reality

Interventions

Short form and frequent eye movement desensitization and reprocessing (EMDR) in virtual reality for specific phobia treatment.

VR EMDR

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have a specific phobia (not necessarily clinically significant)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Northampton

Northampton, Northamptonshire, NN1 5PH, United Kingdom

Location

MeSH Terms

Conditions

Phobia, Specific

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 2, 2025

Study Start

April 28, 2025

Primary Completion

May 2, 2025

Study Completion

May 2, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

The increased risk of patients being identified.

Locations