Clinical trial NCT06981611: Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia
Official title: Vulvodynia Intervention (VI): the Effect of Multimodal Treatment for Provoked Vulvodynia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vulvodynia (Chronic Vulvar Pain)
Keywords: Vulvodynia
Provoked vulvodynia
multimodal treatment
cognitive behavioral therapy
cbt
couple treatment
single-case experimental design
sced
chronic pain
Vulvodynia Intervention
Lead sponsor: Karlstad University
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Region Örebro County
name: Region Jönköping County
name: Region Värmland
First posted: 2025-05-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study utilizes a sequential single-case experimental AB design with randomized waiting period length (4, 5 or 6 weeks). Included in the design is also a pre-, post- and 6 month follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from patients, to explore experiences of participation in the study and the treatment.
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to develop and evaluate a multimodal treatment for provoked vulvodynia, by addressing the following specific research questions:

1. What is the feasibility and acceptability of this multimodal treatment protocol?
2. What are the effects on pain and psychosexual health?
3. How is the treatment perceived by patients, clinicians and stakeholders in the health care setting, and how do they view the possibilities for implementation?

Participants will be recruited through their health care unit and receive a multimodal treatment. The treatment consists of individual sessions with different professionals, in total 11 sessions over a time period of four months. It is possible to involve partners in the treatment during two of the treatment sessions. The majority of the sessions are digital video meetings but some are conducted at the health care unit. The treatment are based on physiological and psychosocial components that have previously shown positive effects for individuals with vulvodynia, and includes both educational and practical elements.

The participants will:

* Undergo a gynecological examination and a psychological assessment to determine if the treatment is suitable for their condition
* Undergo a multimodal treatment
* Complete questionnaires regarding their pain, physical tension, psychosexual and relational health and questions about the treatment
* Be asked to participate in an interview about their experience of the treatment and intimacy

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

Biological sex: Female 18-40 years old Provoked vulvodynia

Exclusion Criteria:

* Severe psychological issues that should be prioritized before vulvodynia treatment (e.g., substance abuse, psychosis)
* Ongoing pregnancy
* Childbirth within the last year
* Post-traumatic stress disorder (PTSD) related to sexual trauma
* Insufficient mastery of the Swedish language
* No experience of vaginal sex, as vaginismus might be suspected, which requires different treatment

Primary outcomes:
measure: Change in pain during touch and/or insertion of an object
timeFrame: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up, during baseline (4, 5 or 6 weeks) and treatment period measured twice a week for 25 weeks.
Secondary outcomes:
measure: Change in sexual function
timeFrame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
measure: Change in treatment goal attainment
timeFrame: 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.
measure: Change in pelvic floor tension
timeFrame: 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.
measure: Change in sexual satisfaction
timeFrame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
measure: Change in interpersonal and self focused sexual goals
timeFrame: Pre and post treatment (25 weeks after the baseline measurement started), and at 6 months follow-up
measure: Change in perceived intimacy
timeFrame: Pre and post treatment (25 weeks after the baseline measurement started), and at 6 months follow-up
measure: Change in life interference, sexual function interference and impact on relationship
timeFrame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
measure: Change in depressive symptoms
timeFrame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
measure: Change in anxiety symptoms
timeFrame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
measure: Change in quality of life
timeFrame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Other outcomes:
measure: Evaluation of how much time participants spend on the treatment and related exercises
timeFrame: during treatment period
measure: Demographic
timeFrame: Pre treatment (25 weeks after the baseline measurement started). Questions about partner/-s are measured pre and post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up.
measure: Change in sexual desire and arousal
timeFrame: Repeated measure twice a week during baseline and treatment period, for 25 weeks.
measure: Change in pain catastrophizing
timeFrame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
measure: Change in avoidance and endurance related to sexual activities
timeFrame: Repeated measure twice a week during baseline and treatment period, for 25 weeks
measure: Experiences of sexual and physical abuse
timeFrame: Pre treatment
measure: Treatment expectations
timeFrame: Pre treatment
measure: Negative treatment effects
timeFrame: Post treatment (25 weeks after the baseline measurement started)
measure: Perceived treatment improvement and satisfaction
timeFrame: Post treatment (25 weeks after the baseline measurement started)
measure: Change in sexual pain coping
timeFrame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
measure: Experience of treatment
timeFrame: Post treatment (25 weeks after the baseline measurement started)
Locations:
city: Karlstad
country: Sweden
facility: Karlstad University
Study officials:
References: