Virtual Reality and Post Traumatic Stress
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: 360 Video, VR Photoscan, Standard TF-CBT.
- Кому может быть актуально
- Состояния в реестре: PTSD - Post Traumatic Stress Disorder. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Virtual Reality and Post-Traumatic Stress - Exploring the Feasibility and Acceptability of Low-Cost Virtual Reality and 360 Video to Treat Post Traumatic Stress Disorder
Обзор
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.
Подробное описание
Background Northern Ireland is a country that has recently emerged from around 30 years of civil conflict that has resulted in the deaths of over 3500 people. This period known colloquially as 'The Troubles' has resulted in a legacy of trauma-related mental health problems and has a higher estimated prevalence of Post-Traumatic Stress Disorder (PTSD) than any other comparable country that has experienced civil conflict. This has resulted in an estimated 39% of the population experiencing (directly or indirectly) a conflict-related 'event'. PTSD has an estimated prevalence of 3.6% in the general world population and a disproportionately high prevalence of 5.1% among the Northern Ireland population.
Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) has been demonstrated to be an effective treatment for PTSD evolved from the Ehlers and Clark Cognitive Model of persistent PTSD. The evidence-based treatment of non-conflict related trauma such as sexual assault, and road traffic accidents has highlighted the effectiveness and common acceptance of TF-CBT and is currently recommended by the NICE as the first line of clinical treatment for PTSD. TF-CBT for individuals in Northern Ireland suffering from PTSD which has arisen from acts of terrorism and civil conflict has added to the emergent evidence base as a successful therapeutic intervention.
The model, Ehlers \& Clark, suggests that PTSD can develop if the patient continues to feel a sense of current threat after the trauma has ended, which can lead to further dysfunctional behaviors and feelings, even after the event has taken place. During the course of therapy, clients with PTSD revisit the trauma memory in order to fully process what has occurred. This technique is known as Imaginal Exposure (IE) via Reliving and whilst shown to be effective, IE can be a difficult process for clients given the associated, somatic and cognitive symptoms that it incurs. People diagnosed with PTSD can be highly avoidant and emotionally distant from trauma memories, meaning they find it challenging to engage with the exposure process. In addition, when trauma has occurred several decades previously, the trauma memory may be difficult to access or may have lost detail resulting in poor treatment outcomes.
Given the role of imaginal techniques within PTSD treatment, a growing number of studies have explored the use of immersive technology such as Virtual Reality (VR) to support this process. VR is no longer a futuristic concept and headsets are readily accessible, being used in many households for entertainment purposes. Currently, there are many ways to create a virtual world and if used correctly can be therapeutically helpful to patients and clinicians. VR can generate environments such as social settings or classrooms that essentially simulate real or imagined worlds to meet the specific clinical requirements of the patient in therapy. Through the use of VR, patients can enter a world in which they are exposed to a traumatic memory in a controlled therapeutic way, and, as a result, has been shown to be effective in the treatment of PTSD patients across a number of settings such as military combat, terrorist attacks, and road traffic accidents. Specific to the military, in 2003, due to the deployments to Afghanistan and Iraq there was an increase in combat-related PTSD which the United States recognised the need to advance in evidence-based treatments to address these complexities. Despite these successes, there is yet to be a widespread adoption of VR-based interventions for PTSD in routine clinical settings. Potential barriers are hypothesized to occur due to the idiosyncratic nature of the trauma memory, which requires the recreation of a personalized environment and thus has significant cost implications. Another barrier may be due to the acceptability or lack thereof of these new technologies among clinicians.
Theoretical Framework
The clinical presentation of PTSD is idiosyncratic; with specific symptoms experienced differing from individual to individual. Unwanted, intrusive, and involuntary distressing memories of the traumatic event are a core symptom of PTSD. Most successful treatment protocols for PTSD focus on the patient's memory of the traumatic event and its meaning. Therefore, a range of interventions have been developed to reduce the stress associated with these memories. Such interventions include Prolonged Exposure (PE), imaginal reliving of the trauma, and cognitive interventions to support the elaboration of traumatic memory to link with autobiographical memories. For this study, Ehlers and Clark's Cognitive Model of Persistent PTSD was used as a framework to develop the current treatment protocol.
In their cognitive model, they posit that chronic PTSD develops because individuals engage in sensory processing of the event rather than processing the meaning and implications. This causes disturbance in autobiographical memory, i.e., episodic (personal memories including places, objects, events) and semantic memory (memories about general knowledge and facts). Subsequently, this prevents the processing of trauma memories. They also postulated that individuals who experience PTSD develop excessively negative appraisals in which the probability of risk of harm is overestimated, and the ability to cope with threat is underestimated. Such maladaptive cognitive errors/biases cause avoidance of threats and provide short-term relief. These include avoiding trauma-related stimuli, and remembering or suppressing unwanted trauma-related thoughts. However, in the long term, these activities maintain the sense of persistent threat as the coping strategies prevent negative appraisals from being corrected. Thus, the authors proposed that recalling the traumatic memories and updating them is the core of trauma treatment. 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 the present tense, including recalling images, sensory experiences, thoughts, and feelings. VR-based PTSD treatments can promote emotional engagement and the process of trauma by providing visual, auditory, and haptic sensory cues. The investigators posit that a similar effect can be achieved via the use of 360° video or VR Photoscan technologies.
This study seeks to address these barriers by implementing two acceptable but lower-cost alternatives to VR, namely (1) Immersive 360° Video and (2) VR Photoscan technology in a routine clinical setting in Northern Ireland.
Project Aim and Objectives 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.
Objectives
1. To explore the user (clinician and patient) acceptability of 360° video and VR Photoscan within a routine mental healthcare setting. 2. To understand the factors surrounding the recruitment and retention of participants using 360° video and VR Photoscan within a routine mental healthcare setting. 3. To explore differences between participants receiving 360° video or VR Photoscan or treatment as usual (TAU) within a routine mental healthcare setting using a three-arm design.
Intervention Developments (See Arms and Interventions Section)
Methods
This is a three-arm intervention development study using a mixed methods evaluation framework designed to explore and refine the use of low-cost VR as an adjunct within existing TF-CBT therapy. The study will take place within the Regional Trauma Network based in the South-Eastern Trust (SET). This study of approximately 15 participants (N=15) selected from the waitlist will be screened for suitability of therapy to treat conflict-related PTSD. The participants will be split into three random N-5 groups.
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.
It is preferred that the site trauma is suitable for the two arms of the study, but on the occasion that this is not possible, participants will be selected for each arm based on the accessibility of the trauma.
In line with the standard RTN OUTCOMES: MEASURES AGAINST STAGE OF THERAPY, each stage of treatment uses a choice of measures to collect data outcomes. (See the Outcome Measures section for more detail). Additionally, the co-researcher will hold semi-structured interviews to gather the views and experiences of the clinicians and clients once the intervention has ended.
Recruitment and Sampling
The target sample size is 15 participants (N-15). Recruitment is likely to take place in September 2023.
Numerous meetings have been held between the research team at QUB and the SET Regional Trauma Network to ensure the approach is refined and effective, ensuring the flow of the study and minimizing the additional workload for the clinicians involved. The Regional Trauma Network will be responsible for the recruitment under the lead of the Consultant Clinical Psychologist. Standard practice within the Regional Trauma Network is a four-stage RTN Flowchart in which during initial assessment baselines are collected and readiness and commitment for therapy are evaluated, at this stage a brief overview of the trauma location will be gathered and accessibility assessed for the purpose of the VR. It is amenable that both arms of the study are met however on the occasion this is not possible, participants will be selected based on suitability. A purposive sampling technique will gauge the service users' interest and suitability based on the exclusion and inclusion criteria of the study (See Eligibility section) which will be added to a series of questions within the RTN Screening Proforma. If clients show interest, the clinician will provide them with the Participants Information Sheet and the Consent Form. The decision to take part (or not) will not impact the service that they receive. As such, if the participant does not show interest in the study, they will remain on the standard treatment waitlist. Suitable participants will then be placed on a waitlist for the purpose of this study. As per the RTN Screening Proforma, the PIS will be disseminated to the GP alongside the Screening Outcome Letter to ensure the GP receives sufficient details on the study. The clinicians (N-5) identified to take part in the study are employed directly through SET are a Consultant Clinical Psychologist and four Psychological Therapists (Psychology, Nursing, and Social Work Core Professionals) trained in delivering TF-CBT. Each clinician will be trained in the use of both 360° video and VR Photoscan technologies. Patients will be screened with those referred earliest seen first. From the resultant list of consulting patients, they will be randomly allocated where possible to the three arms. A maximum of 5 patients per group will be assigned until all arms are full.
As per NICE guidelines standard treatment includes around 8-12 meetings and sessions at least approximately 60-90 minutes. As this study will be working with complex PTSD, therapy can run into 20+ sessions. The endpoint for data collection for this study will be after approximately 16-20 sessions
Randomization
Randomization will take place following registration and completion of baseline measures based on the acceptability of 360° video and VR Photoscan technology. Each participant
Вмешательства
- Поведенческое 360 Video
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 phot - Поведенческое VR Photoscan
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 system - Поведенческое Standard TF-CBT
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 treatme
Первичные конечные точки
- PCL 5 - Measure for PTSD [Срок оценки: From enrolment to the end of treatment approx. week 16]
- ITQ - International Trauma Questionnaire [Срок оценки: From enrolment to the end of treatment approx. week 16]
Вторичные конечные точки (5)
- Beck Depression Inventory-II [Срок оценки: From enrolment to the end of treatment approx. week 16]
- Igroup Presence Questionnaire [Срок оценки: 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) [Срок оценки: From enrolment to the end of treatment approx. week 16]
- Measurement of Subjective Unit of Distress Scale (SUDS) [Срок оценки: 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 [Срок оценки: 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.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
Великобритания · 1 центр
- South Eastern Health and Social Care Trust (Regional Trauma Network) — Belfast
Публикации
- 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
- 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
- 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
- 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
- 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
- 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
- Hess S, Zemishlany Z. [THE PSYCHIATRIC DIAGNOSIS GUIDE - DSM-5 - INNOVATIONS AND CRITICISM]. Harefuah. 2015 May;154(5):319-22, 338. Hebrew. PMID 26168644
Идентификаторы
NCT: NCT06684977 · IRAS Project ID - 325495