Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia

The study design consists of a mixed-methods design, where different methods are applied in the various sub-studies of the project.

Study 1, is an effectiveness evaluation, applying a sequential single case experimental AB design (SCED) with randomized baseline length, replicated across five healthcare contexts (n≈10-15 per unit, total N≈50-75).

Potential participants will be informed about the study at their health care unit and answer a few questions digitally to ensure that participation in the study is appropriate for them. An assessment will then be conducted and questions will be asked about the pain, psychological, sexual and relational health, and a diagnostic interview will be conducted to exclude other psychological issues that needs to be prioritized before vulvodynia treatment. After the assessment interview and inclusion, participants will be randomized to a 4, 5, or 6 week baseline period. Thereafter, the treatment will begin. During the baseline and treatment period, participants will complete a short self-assessment questionnaire, twice a week, to measure pain (primary outcome) and other key variables. To facilitate the repeated assessments, we will use the m-Path app, which was developed by KU Leuven University in Belgium to easily evaluate treatment for both patients and therapists. In addition to the repeated assessments, the treatment will be evaluated through a comprehensive web-based self-assessment questionnaire before and after the intervention and at a six-month follow-up, using the secure survey system called Survey and Report. through Karlstad university. The outcome measures are based on the ongoing work by the Swedish Agency for Health Technology Assessment and Assessment of Social Services.

Study 2, is a qualitative evaluation and initial assessment of the possibilities for implementing the treatment in the Swedish healthcare context.

Individual interviews with patients will be conducted and questions will be asked regarding their experience of the treatment model. Focus group interviews will be conducted with practitioners and questions will be asked regarding relevance, relative advantages, consistency with standard practices, usability, and adaptability. Since the treatment will be carried out in five healthcare units with different organizational and practical conditions, questions will specifically address unit-specific aspects that therapists and patients perceive as having facilitated or hindered the implementation and what could be improved in both treatment content and execution. The questions are based on the recommendations of the Swedish National Board of Health and Welfare and the Public Health Agency regarding the initial assessment of implementation possibilities.

To obtain the healthcare organization's perspective on implementation possibilities, interviews will be held with health care stakeholders within the participating healthcare units. These interviews will also focus on relevance, relative advantages, consistency with standard practices, usability, and adaptability.

The individual and focus group interviews will be conducted in person at the health care units or through digital video meetings. Data from focus group interviews and individual interviews will be recorded by audio, transcribed, and analyzed according to standard qualitative analysis methods, primarily inductive empirically driven Thematic Analysis (TA).

• Change in sexual function [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
• Change in treatment goal attainment [Срок оценки: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.]
• Change in pelvic floor tension [Срок оценки: Pre, post treatment (25 weeks after the baseline measurement started) and at a 6 month follow-up. During baseline and treatment period measured twice a week, for 25 weeks.]
• Change in sexual satisfaction [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
• Change in interpersonal and self focused sexual goals [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started), and at 6 months follow-up]
• Change in perceived intimacy [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started), and at 6 months follow-up]
• Change in life interference, sexual function interference and impact on relationship [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
• Change in depressive symptoms [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
• Change in anxiety symptoms [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
• Change in quality of life [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]