Internet-based treatment for vulvodynia (EMBLA) – Study protocol for a randomised controlled study

Abstract

Background Vulvodynia is defined as vulvar pain for at least 3 months without a clear cause. To the best of our knowledge, there are no trials investigating the effects of internet treatment using CBT (Cognitive behavioural therapy) treatment with Acceptance and Commitment Therapy (ACT) components for women with vulvodynia. The aim of this study is to examine the effects of such a guided internet-based intervention on provoked vulvar pain during the waiting period before clinical treatment. Methods We will randomise 52 patients to either guided internet-based intervention with CBT with (ACT) components or no intervention during the waiting period for treatment as usual. Online assessments are conducted at baseline, posttreatment, and at follow-up after 9 months. The primary outcome measure is provoked vulvar pain. Secondary outcomes are depression, anxiety, sexual function, and quality of life. Linear-mixed effect models will be used to assess the effect of the internet-based intervention on vulvar pain, pain acceptance, depression, anxiety, sexual function, and quality of life over time, by applying the intention-to-treat approach. Continuous data will be analysed with general linear models using intention-to-treat and also per protocol approaches to assess the effects of the intervention at different time points. Ordinal and binary data will be analysed with Mann Whitney's test, Fischer's exact test and multivariate logistic regression, respectively. Discussion As a randomised controlled trial with short- and long-term follow-up points, the EMBLA study intends to provide a novel and better understanding regarding the treatment of vulvodynia and the role of internet-based treatment as a complement to standard care for women suffering from vulvodynia. The effects of vulvodynia on pain, sexual function, quality of life, depression, and anxiety are investigated. The study's results are expected to be of value in the planning of clinical care in the medical area. High dropout rates and technical difficulties associated with using the platform are common in similar studies. Trial registration number NCT02809612

Experiences of internet-based treatment for vulvodynia: A qualitative study

“…Women who had completed the EMBLA study's internet-based treatment were eligible for participation in the present study. Eligibility was assessed by a telephone screening interview using a structured questionnaire for diagnostics of provoked vulvodynia [21,22].…”

“…It consisted of six modules and each module had a different theme and encompassed both information and exercises. A full description of the eligibility criteria for the randomized trial, and the intervention are described elsewhere [18,22].…”

“…The criteria for inclusion were to be over 18 years, to present symptoms of provoked vulvodynia for at least 6 months, to have access to a computer and internet, and to have a Swedish personal identification number as it was a requirement to be able to log in to the platform. Unclear diagnosis after the telephone screening interview, language barriers and severe or acute mental illness were criteria for exclusion [18,22].…”

Health economic evaluation of a randomized controlled trial (EMBLA study), an internet-based treatment for provoked vulvodynia

“…This health economic evaluation has a healthcare service perspective and is based on data from the EMBLA study, a multicenter randomized study that investigated the effects of a 6-week guided internet intervention for provoked vulvodynia 21 . The study was approved by the Ethical Regional Board in Uppsala, Sweden (registration numbers 2015/031 and 2020–07,179), and registered at clinicaltrials.gov (protocol ID EMBLA, ID NCT02809612, 22/06/2016).…”

“…Up to this point, to our knowledge, only one randomized clinical trial investigating the effects of internet-based treatment for provoked vulvodynia could be identified 21 , 22 . The results of that study indicated that internet-based treatment for provoked vulvodynia reduced pain during intercourse and increased pain acceptance 21 , 22 . This form of treatment has been described as credible and helpful to manage vulvodynia symptoms 23 .…”