Virtual Reality and Post Traumatic Stress

NCT06684977 | Enrolling By Invitation

• 1 other identifier: IRAS Project ID - 325495
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Northern Ireland has a legacy of trauma-related mental health problems and a higher estimated prevalence of post-traumatic stress disorder (PTSD) than other comparable post-civil conflict societies. Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) is an effective treatment for PTSD and is currently recommended by the National Institute For Health and Social Care Excellence (NICE) as the first line of clinical treatment. During therapy, clients with PTSD revisit the trauma memory to process what has occurred. This technique is known as Imaginal Exposure (IE) which can be a difficult process. Clients can be highly avoidant and emotionally distant from trauma memories, making it challenging to engage with the exposure process. When trauma has occurred several decades previously, traumatic memories may be difficult to access, resulting in poor treatment outcomes. Technology such as Virtual Reality (VR) can aid this process, as patients can enter a world that exposes them to the traumatic memory in a controlled therapeutic way which has shown to be effective in the treatment of PTSD. VR is yet to be used in routine clinical settings. The investigators are proposing to create low-cost VR environments via 360° video and a new process called VR Photoscan, which will allow a clinical setting to use this beneficial tool to support patients who are receiving TF-CBT to treat PTSD. This is a three-arm intervention feasibility study using a mixed methods evaluation framework designed to explore the acceptability of low-cost VR as an adjunct within existing TF-CBT therapy. Participants will be split into 3 groups of 5: Group one (N=5) to use 360° Video alongside standard TF-CBT. Group two (N=5) to use VR Photo Scan alongside standard TF-CBT. Group three (N=5) is a control group that will only receive TF-CBT. The individuals selected for the technological interventions will be offered the opportunity of a personalized 360° video / VR Photoscan environment to aid their therapy session. Pre and post-measures will be collected from participants and semi-structured interviews will be held with participants at the end of their therapy and with the clinicians who have delivered the intervention. This protocol aims to investigate the potential of low-cost VR technology in supporting PTSD treatment, addressing both the practical and theoretical challenges of immersive trauma therapy. By examining the feasibility of 360° video and VR Photoscan, the study hopes to contribute valuable insights into VR's applicability in clinical mental health settings.

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

PTSD; Trauma; Virtual Reality; Mental Health

Outcome Measures

Primary Outcomes (2)

• PCL 5 - Measure for PTSD

  The PCL-5 is a 20 item self-report scale that assesses the 20 DSM-5 symptoms of PTSD and usually takes 5-10 minutes to complete. DSM-5 symptoms cluster severity scores can be obtained by summing the scores for the items within a given cluster i.e. Intrusion (5 items); avoidance (2 items); negative alteration in cognitions and mood (7 items) and alterations in arousal and reactivity (6 items). These items are rated on a 4-point Likert Scale ranging from 0 (not at all) to 4 (extremely) and are based on the participants experiences over the past month. Interpretation of the PCL-5 is made by the clinician and includes a total symptom severity score range 0-80 by summing the scores for each of the 20 items. A provisional PTSD diagnosis can be made using this scale and research suggests a PCL-5 cut off score between 31-33 is indicative of probable PTSD.

  From enrolment to the end of treatment approx. week 16

• ITQ - International Trauma Questionnaire

  The ITQ is an 18-question self-report measure that focuses on the core features of PTSD and Complex PTSD. All ITQ items are answered on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Scores are calculated for each symptom allowing clinicians to assess both PTSD and C-PTSD symptom severity. Higher scores typically indicate greater severity of trauma-related symptoms.

  From enrolment to the end of treatment approx. week 16

Secondary Outcomes (5)

• Beck Depression Inventory-II

  From enrolment to the end of treatment approx. week 16

• Igroup Presence Questionnaire

  This measure will be given at the end of the first session where 360° video or VR Photoscan technology has been used. Approx. week 4

• Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)

  From enrolment to the end of treatment approx. week 16

• Measurement of Subjective Unit of Distress Scale (SUDS)

  This measure will be used during the sessions in which 360° video or VR Photoscan technology has been used. Approx. Week 4-8

• United Theory of Acceptance and Use of Technology (UTAUT2) Scale

  Clinicians will complete a pre measure prior to enrolment and post, once they have completed the intervention using both arms of the technology. On average, one year.

Study Arms (3)

Treatment As Usual

ACTIVE COMPARATOR

(N=5) as a control group who will only receive TF-CBT.

360 Video

EXPERIMENTAL

(N=5) to use 360° Video alongside standard TF-CBT.

VR Photoscan

EXPERIMENTAL

(N=5) to use VR Photo Scan alongside standard TF-CBT.

Interventions

360 Video BEHAVIORAL

360° Video consists of video recordings, made with a camera to simultaneously capture and combine scenes in a 360 degrees perspective such as Instant Google Street View Instant Google Street View (instantstreetview.com). When uploaded to a VR headset, 360° videos may provide a more cost-effective method for rapidly creating virtual environments in which users can experience a sense of immersion and the viewer can control and change the viewing angle at any stage through head movement. While photorealism may be superior, this option is known to be less interactive as the viewer can't move or walk around within the virtual space. In addition, the landscape and imagery may have been changed or developed meaning the recordings captured do not match the traumatic memory. Despite these limitations, the use of 360° video has been trialled in clinical mental health settings showing positive outcomes for both user and clinician.

VR Photoscan BEHAVIORAL

VR Photoscan creates immersive virtual environments by transforming real-world imagery into detailed 3D models. Using high-resolution images captured from a smartphone, these images are processed in 3D graphics software to sculpt realistic virtual scenes. The resulting 3D models are imported into a game engine, adding VR functionality, allowing users to navigate freely with six degrees of freedom. Interactive content, such as animated cars and people, can be added in real-time, while menu systems guide users through the experience. Environmental factors like lighting, weather, and time of day can be adjusted to simulate real conditions. Spatial 360° audio enhances immersion, providing sounds from various directions. This VR environment creation process is efficient and cost-effective, requiring no specialised equipment, and ensuring high-quality immersive experiences at minimal production time and cost.

Standard TF-CBT BEHAVIORAL

Ehlers and Clark's model follows the general style of reliving (recommended by NICE) suggested by Foa and Rothbaum with some fluidity and in vivo exposure (i.e., trauma site visit). During the treatment process of reliving, clients are asked to close their eyes and intentionally recall the traumatic memories, i.e., relive the trauma in their mind in detail and narrate their experience in present tense, including recalling images, sensory experiences, thoughts, and feelings. VR-based PTSD treatments can promote emotional engagement and the process of trauma via providing visual, auditory, and haptic sensory cues.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who self-report the experience of type 1 trauma (NI related)
• PTSD symptoms as identified via PCL-5 \> 31
• Ability to give informed consent
• Suitable and willingness to engage in TF-CBT
• Scene of the traumatic event is accessible for 360° video or VR Photoscan

You may not qualify if:

• History of severe motion sickness
• History of seizures, seizure disorder, or epilepsy
• History of bipolar disorder, psychosis, or schizophrenia
• Younger than 18 years old
• Experiences their trauma at a site that is not accessible (i.e., would not be possible to capture images)
• Previously engaged in TF-CBT within the PTS in the past 12 months
• Actively suicidal or undertaken suicidal action in the past 3 months

Sponsors & Collaborators

• Queen's University, Belfast: lead
• South Eastern Health and Social Care Trust: collaborator

Study Sites (1)

South Eastern Health and Social Care Trust (Regional Trauma Network)

Belfast, Dundonald, BT16 1RH, United Kingdom

Location

Related Publications (7)

• Rothbaum BO, Hodges LF, Ready D, Graap K, Alarcon RD. Virtual reality exposure therapy for Vietnam veterans with posttraumatic stress disorder. J Clin Psychiatry. 2001 Aug;62(8):617-22. doi: 10.4088/jcp.v62n0808.

  PMID: 11561934 BACKGROUND

• Ehlers A, Clark DM, Hackmann A, McManus F, Fennell M. Cognitive therapy for post-traumatic stress disorder: development and evaluation. Behav Res Ther. 2005 Apr;43(4):413-31. doi: 10.1016/j.brat.2004.03.006.

  PMID: 15701354 BACKGROUND

• Difede J, Hoffman H, Jaysinghe N. Innovative use of virtual reality technology in the treatment of PTSD in the aftermath of September 11. Psychiatr Serv. 2002 Sep;53(9):1083-5. doi: 10.1176/appi.ps.53.9.1083. No abstract available.

  PMID: 12221305 BACKGROUND

• Blair C, Walsh C, Best P. Immersive 360 degrees videos in health and social care education: a scoping review. BMC Med Educ. 2021 Nov 24;21(1):590. doi: 10.1186/s12909-021-03013-y.

  PMID: 34819063 BACKGROUND

• Beck JG, Coffey SF, Palyo SA, Gudmundsdottir B, Miller LM, Colder CR. Psychometric Properties of the Posttraumatic Cognitions Inventory (PTCI): a replication with motor vehicle accident survivors. Psychol Assess. 2004 Sep;16(3):289-98. doi: 10.1037/1040-3590.16.3.289.

  PMID: 15456384 BACKGROUND

• Anderson PL, Price M, Edwards SM, Obasaju MA, Schmertz SK, Zimand E, Calamaras MR. Virtual reality exposure therapy for social anxiety disorder: a randomized controlled trial. J Consult Clin Psychol. 2013 Oct;81(5):751-60. doi: 10.1037/a0033559. Epub 2013 Jun 24.

  PMID: 23796315 BACKGROUND

• Hess S, Zemishlany Z. [THE PSYCHIATRIC DIAGNOSIS GUIDE - DSM-5 - INNOVATIONS AND CRITICISM]. Harefuah. 2015 May;154(5):319-22, 338. Hebrew.

  PMID: 26168644 BACKGROUND

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Wounds and Injuries; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Dr Best, MSc in CBT

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: June 10, 2024
• Primary Completion: October 10, 2025
• Study Completion: December 31, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)