Mindfulness-Based Group Cognitive Behavior Therapy for Provoked Localized Vulvodynia: A Randomized Controlled Trial

Guillet, Alyson; Cirino, Nicole; Hart, Kyle D.; Leclair, Catherine M.

doi:10.1097/lgt.0000000000000456

Cited by 23 publications

(20 citation statements)

References 38 publications

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“…The tampon test was chosen as a primary outcome based on recommendations for self-report outcome measures in vulvodynia clinical trials (33). This test has been used as a primary outcome measure in various clinical trials for vulvodynia, evaluating the effect of various treatments (34)(35)(36)(37)(38)(39)(40). It is an alternative measure for pain associated with vulvovaginal penetration and allows the inclusion of women with PVD who are unable to have intercourse.…”

Section: Registration Of Received Treatment Assessment Packagementioning

confidence: 99%

Feasibility and Acceptability of Somatocognitive Therapy in the Management of Women with Provoked Localized Vestibulodynia - ProLoVe Feasibility Study

Kaarbø¹,

Danielsen²,

Haugstad³

et al. 2021

Preprint

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Background: Provoked vestibulodynia (PVD) is a prevalent chronic pain condition especially among young women. Pain is localized to the vulvar vestibule and is provoked by touch or pressure, such as penetrative intercourse. PVD can have profound consequences, adversely affecting a woman’s sexual life, relation to her partner and her psychological health. There is an urgent need for well-designed randomized clinical trials (RCTs) to identify the most effective interventions for this neglected women’s health condition. Aims: The primary aim of this study is to assess the feasibility of undertaking a full-scale RCT of somatocognitive therapy (SCT), a multimodal physiotherapy intervention, for women with PVD. The secondary aim is to evaluate implementation and acceptability of SCT and its potential treatment effectiveness in PVD. In the full-scale RCT SCT will be compared to standard PVD treatment.Methods: This multi-method feasibility study utilized a single subject study design with nested qualitative data. Ten women with PVD, aged 18-35, were recruited from the Vulva Clinic at Oslo University Hospital. The intervention took place at Oslo Metropolitan University. Participants were assessed at baseline, post-treatment and at the eight month’s follow-up with the tampon test and self-report questionnaires. The main feasibility outcomes were evaluation of recruitment rate, adherence to assessment tools and follow-up rate. The participants’ experiences with the primary outcome and the intervention were explored with semi-structured interviews. Results: Ten out of 18 eligible patients were recruited over 11 weeks. None were lost to follow-up. Adherence to self-report questionnaires was excellent. Adherence to tampon tests and to the reporting of treatments was good, whereas adherence to the 14-day diary was poor. No adverse events were reported. The tampon test was suboptimal as a primary outcome. SCT was found to be an acceptable treatment based on Global Perceived Effect scores and the participants’ experiences.Conclusion: The findings suggest that it is feasible to deliver a full-scale RCT of the SCT intervention for women with PVD. Some changes are suggested to optimize the protocol, such as increasing recruitment sites, change of primary outcome measure and adding a booster session. Trial registration: ClinicalTrials.gov NCT04208204, Registered December 23, 2019 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04208204

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Section: Registration Of Received Treatment Assessment Packagementioning

confidence: 99%

Feasibility and Acceptability of Somatocognitive Therapy in the Management of Women with Provoked Localized Vestibulodynia - ProLoVe Feasibility Study

Kaarbø¹,

Danielsen²,

Haugstad³

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…There are also promising results regarding CBT intervention delivered via the internet for women with sexual dysfunction, including genital pain ( Jones and McCabe, 2011 ). Further, in two trials regarding mindfulness cognitive therapy, also called third wave cognitive behavioural therapy, an effect, similar to CBT, on pain and sexual function is reported ( Brotto et al, 2015 ; Guillet et al, 2019 ).…”

Section: Introductionmentioning

confidence: 99%

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

Engström

Jawad

Hesselman

et al. 2021

Internet Interventions

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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

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“…The test has been used as a primary outcome measure in various clinical trials for vulvodynia ranging from case studies, 6 case series, 7 to several randomized clinical trials (RCTs). [8][9][10][11][12] Furthermore, the tampon test has been used as part of the trial inclusion process, where an average pain level of four, or greater, on the NRS has been required to fulfil the eligibility criteria. 9,10,13,14 Nevertheless, it is unknown if pain experienced during this test is proportional to, or representative, for the pain experienced during intercourse, or if such inclusion criteria may deprive some women with PVD from study participation.…”

Section: Introductionmentioning

confidence: 99%

The Tampon Test as a Primary Outcome Measure in Provoked Vestibulodynia: A Mixed Methods Study

Kaarbø

Danielsen

Haugstad

et al. 2021

The Journal of Sexual Medicine

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Background: Provoked vestibulodynia (PVD) is characterized by severe pain, often induced by penetrative sex. This may lead to women abstaining from sexual intercourse, hence the recording of pain intensity levels in PVD research is often challenging. The standardized tampon test was designed as an alternative outcome measure to sexual intercourse pain and has frequently been used in clinical studies. Aim: The aim of this mixed methods study is to evaluate the tampon test as a primary outcome measure for an upcoming randomized clinical trial for women with PVD. Methods: An explanatory sequential design was applied, integrating quantitative and qualitative methods. In phase one, pain intensity levels were evaluated with the tampon test amongst 10 women, aged 18-33, with PVD. The test was repeated on day 1, 7 and 14. Pain intensity was rated on the Numerical Rating Scale (NRS), (0-10), 10 being worst possible pain. In phase two, the participants' experiences with the test were explored with semi-structured interviews using a descriptive and inductive qualitative design. All participants were recruited from the Vulva Clinic,

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Mindfulness-Based Group Cognitive Behavior Therapy for Provoked Localized Vulvodynia: A Randomized Controlled Trial

Cited by 23 publications

References 38 publications

Feasibility and Acceptability of Somatocognitive Therapy in the Management of Women with Provoked Localized Vestibulodynia - ProLoVe Feasibility Study

Feasibility and Acceptability of Somatocognitive Therapy in the Management of Women with Provoked Localized Vestibulodynia - ProLoVe Feasibility Study

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

The Tampon Test as a Primary Outcome Measure in Provoked Vestibulodynia: A Mixed Methods Study

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