Implementing Virtual Reality Exposure Therapy for Vaginismus: From Efficacy to Clinical Integration (VIVID 3)

PURPOSE: Vaginismus is a gynecologic condition characterized by involuntary tightening of the pelvic floor muscles. It is defined by intense fear of vaginal insertion, leading to persistent difficulties with vaginal intercourse and gynaecological exams The anticipation of pain provokes hypervigilance, negative cognitions, and avoidance behaviour, leading vaginismus to be conceptualized as a phobia. Equipped with data from Studies 1 and 2 from our 3-stage program for VRE to treat vaginismus, we have demonstrated that our VRE paradigm is feasible to deliver, usable, satisfactory to participants, and highly efficacious. We are now ideally positioned to evaluate the implementation of our VRE paradigm at VCH's BCCVH, which offers multidisciplinary treatment for individuals with chronic and distressing vulvo-vaginal pain and fear of vaginal insertion. Our goal is to use implementation science to study the phased implementation of our VRE protocol within the BCCVH, ultimately leading to better treatment options for women with vaginismus.

JUSTIFICATION: Lack of effective treatments: While vaginismus is common, believed to impact 6% of the female population, it remains underdiagnosed, effective treatment options are limited, and patients often feel dismissed by care providers. Available psychological treatments for vaginismus rely on gradual self-insertion of vaginal dilators at home combined with psychological therapy. However, many individuals experience severe fear and avoidance that make it difficult to engage with these exercises, reducing treatment success. VRE Theoretical approach: This project uses a theoretical approach recognizing that the psychological fear of pain drives hypervigilance to sexual stimuli, leading to physiological responses such as tightening of the pelvic floor muscles which in turn causes physical pain. Thus, addressing fear is a key piece of managing this condition and can be achieved through fear extinction approaches such as exposure therapy. Traditionally, this approach involves repeatedly exposing an individual to the fear-inducing stimulus until their fear decreases (habituates). When exposure is successful, a new association develops and inhibits the retrieval of the original fear memory. Our VRE paradigm is built upon this theory. VRE immerses people in 3D simulations of feared situations and is as effective as real-life exposure for specific phobias. VRE for vaginismus is gradual exposure to feared sexual encounters in a virtual environment and can diminish phobic responses to vaginal insertion. Given that people with vaginismus cope via intense avoidance and often do not perform recommended at-home exposure exercises, the "immersive" nature of VRE ideally target this avoidance.

PROOF OF CONCEPT: Findings from Study 1 \& 2 of this 3-stage VRE research program showed that: 1) VR sexual stimuli elicit a greater fear in individuals with vaginismus relative to individuals without, 2) most participants would participate in a VRE intervention in clinic if it was available, and 3) participants strongly support the efficacy of the VRE approach. Together, these findings support the readiness to move forward with preparing for clinic implementation of this approach. The BCCVH is a provincial referral centre providing interdisciplinary, evidence-based care for vulvar and pelvic pain conditions, seeing 250 new patients each year. Its established clinical infrastructure, patient volume, and commitment to innovation make it an ideal setting to evaluate the implementation of VRE within existing clinic workflow.

OBJECTIVES: Our goal is to use implementation science to study the phased implementation of our VRE protocol within the BCCVH. The specific aims are to: (1) Conduct a barriers/facilitators assessment; (2) Evaluate clinician uptake, feasibility, and acceptability with pilot implementation of VRE; and (3) Assess patient reported outcomes of anxiety, sexual distress, pain, and home treatment engagement after VRE.

• Implementation of Virtual Reality Exposure (Behavioral): To inform implementation, clinicians at BCCVH (n=6) will participate in individual semi-structured interviews prior to implementation to identify barriers and facilitators. Findings from these interviews will refine the implementation protocol. Following implementation, clinicians will complete questionnaires assessing implementation outcomes, including adoption, implementation, and maintenance. Participants (n=167) will receive a single VRE session in addition to standard clinical care at the BCCVH. The VRE session is designed to support treatment of vaginismus and will be delivered according to the study protocol. Participants will complete study questionnaires at baseline and follow-up.

Primary outcomes

• VRE session duration [Assessed every session through study completion, 20 months]: Time duration of a VRE session will be measured from start to end of each VRE sessions in minutes and logged by facilitators in an Excel session log.
• Staff time & resource utilization [Assessed every session through study completion, 20 months]: Staff time, personnel type and equipment used per VRE session will be measured each VRE session and logged by facilitator in an Excel session log.
• Cost of VRE delivery [Assessed at study completion]: Estimated cost per session based on staff time, equipment and other resources used to deliver VRE will be calculated from the Excel resource-use log.
• Technical challenges & adaptations [Assessed every session through study completion, 20 months.]: Number and types of technical challenges encountered when conducting VRE session, and adaptations to protocol made as a result. This will be documented in an Excel study log.
• Fidelity of VRE delivery [Assessed every session through study completion, 20 months.]: Percentage of planned VRE components delivered as intended. Measured using an Excel fidelity log completed by facilitator that conducts VRE session.
• Clinicians trained in VRE delivery [Assessed at time of training (unknown for now).]: Number and proportion of eligible clinicians and staff members receiving training for VRE session delivery. Measured by training attendance log.
• Adoption of VRE [Assessed 6-months and 12-months after implementation.]: Adoption will be measured as the proportion of clinicians who report willingness to incorporate VRE into routine clinical practice following implementation, assessed through a survey.
• Maintenance of VRE [Assessed before implementation, 6-months and 12-months after implementation.]: Clinicians will answer questionnaires on their intention to use VRE, confidence implementing VRE, and perceived skills and readiness to implement VRE.
• Reach [Assessed yearly through study completion, 20 months.]: Number of patients seen in one year at the BCCVH who are offered and accept the VRE session.

Secondary outcomes

• Mean change from baseline in State-Trait Inventory for Cognitive and Somatic Anxiety-State score [Baseline at 48 hours before VRE session, 48 hours after VRE session, and 6-months after VRE session.]: Participants will answer the State-Trait Inventory for Cognitive and Somatic Anxiety, a 21-item measure, 48 hours before the VRE session, 48 hours after the VRE session, and 6-months following the VRE session. Change will be calculated separately from baseline (48 hours before the VRE session) to 48 hours and 6 months after the VRE session.
• Mean change from baseline in Vaginal Penetration Cognition score [Baseline at 48 hours before VRE session, 48 hours after VRE session, and 6-months after VRE session.]: Participants will answer the Vaginal Penetration Cognition Questionnaire, a 40-item questionnaire, 48 hours before the VRE session, 48 hours after the VRE session, and 6-months following the VRE session. Change will be calculated separately from baseline (48 hours before the VRE session) to 48 hours and 6 months after the VRE session.
• Mean change from baseline in Female Sexual Distress score [Baseline at 48 hours before VRE session, 48 hours after VRE session, and 6-months after VRE session.]: Participants will answer the Female Sexual Distress Scale-Revised, a 13-item questionnaire, 48 hours before the VRE session, 48 hours after the VRE session, and 6-months following the VRE session. Change will be calculated separately from baseline (48 hours before the VRE session) to 48 hours and 6 months after the VRE session.
• Mean change from before to after VRE in Shortened State scale of the State-Trait Anxiety Inventory score [Immediately before VRE session and immediately after VRE session.]: Participants will answer the Shortened State scale of the State-Trait Anxiety Inventory, a 6-item measure, immediately before and immediately after completing the VRE session. Change will be calculated as the immediately post-VRE score to immediately pre-VRE score.
• Igroup Presence Questionnaire score [Immediately after VRE session.]: Participants will answer the Igroup Presence Questionnaire, a 14-item questionnaire, immediately after completing the VRE session. Score will indicate the sense of presence in the virtual environment experienced by the participant.
• Reported ease of vaginal accommodator insertion [Immediately after VRE, if optional vaginal accommodator insertion attempted.]: Participants who choose to attempt vaginal accommodator insertion during the VRE session will rate the ease of insertion on a scale from 0 to 10, where 0 indicates "unable to insert-too difficult" and 10 indicates "could insert with ease".
• Reported pain with vaginal accommodator insertion [Immediately after VRE, if optional vaginal accommodator insertion attempted.]: Participants who choose to attempt vaginal accommodator insertion during the VRE session will rate the pain with insertion on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain".

Sex: Female, ages: 19 Years to any

Inclusion Criteria:

* Diagnosis of vaginismus defined by a "marked fear or anxiety about vulvovaginal or pelvic pain in anticipation of, during, or because of vaginal penetration" (criterion from the DSM-5 definition of Genito-Pelvic Pain Penetration Disorder)
* Aged >19 y, of any sexual orientation
* Fluent in English (psychoeducational materials and questionnaires delivered in English)
* Normal or corrected-to-normal vision (to view the VR scenes during exposure)
* Able to travel to Vancouver

Exclusion Criteria:

* Presence of: unprovoked vaginal pain
* Vulvar skin condition (i.e., lichen sclerosus)
* Epilepsy characterized by photosensitive seizures.

Note: provoked vulvar pain is not an exclusion criterion because at least 40% of people with vaginismus report pain with attempted penetration.

• Lori Brotto, Principal investigator, The University of British Columbia