Clinical trial NCT04045041: Internet-based Treatment for Provoked Vestibulodynia
Official title: A Guided Internet-based CBT Treatment for Provoked Vestibulodynia:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Provoked Vestibulodynia
Vulvodynia, Generalized
Keywords: Provoked vestibulodynia
Exposure treatment
Cognitive behaviour therapy
Acceptance and commitment therapy
Pain
Internet-based
Vulvodynia
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Provoked vestibulodynia is a pain condition, which is associated with lower quality of life and discomfort. Furthermore, it is underdiagnosed and undertreated. Provoked vestibulodynia is defined as vulvar pain with no known cause. Provoked vestibulodynia can be generalized and involve several areas of the vulva. It can also be localized and involve only one area of the vulva. Pain is often provoked by touch or pressure but it can also be spontaneous or both. The life prevalence for vestibulodynia varies between 3-28 percent in different populations. Persons with vestibulodynia report more frequently anxiety-, depression- and stress- symptoms than the normal population.

The aim of the present study is to evaluate an internet-based treatment for vestibulodynia. The intervention will be based on Acceptance and commitment therapy (ACT) and cognitive behavior therapy with focus on exposure and acceptance.

Detailed description: Patients suffering from vestibulodynia often experience psychological distress. Acceptance and commitment therapy (ACT) has been shown to be effective in treating psychological distress and pain. However delivering relevant treatment can be difficult due to logistics, cost and lack of personnel with required competence. Delivering ACT though the internet (iACT) is a novel approach, sidestepping logistical issues while lowering costs. There is however, a need to research this kind of treatment for persons with vestibulodynia.

This study will primarily investigate whether an ACT-treatment administered through the internet can be beneficial for patients suffering from provoked vestibulodynia. The treatment will be 10 weeks long. Participants will be randomized to the treatment program or a waiting-list control group. Analysis of possible mediating variables will be able to give insight into the internal workings of the treatment itself, further elucidating efficacy of specific interventions, data which will be useful in future developments of treatment design.

The treatment will consist of a 10-week period where participants would get access to a series of treatment modules, each addressing a separate problem area using ACT techniques. The treatment includes modules focuses on acceptance and exposure techniques. The participants will receive every week different exposure assignments. The platform used is an existing platform employed by the Pain Center at Uppsala university hospital for delivering internet based treatments.

The study will be conducted using a randomized controlled trial with a between-group design. Participants will be randomized to two groups, were one group will gain access to iACT treatment while the second group will be a wait-list control, and will gain access to the program once treatment of the active group is finished. A licensed psychologist will assess participants. In addition to online ACT modules, consisting of information, exercises and homework assignments, all participants will have regular contact by secure email-channel with a licensed psychologists or last-year psychology student under supervision. This contact will guide treatment, providing support, feedback on homework, and if necessary clarify treatment content and help with IT-related problems interfering with treatment adherence. After a year, participants will be invited to take part in a follow-up module, consisting of limited treatment recapitulation and evaluation.

Eligibility criteria: Inclusion Criteria:

* suffer from provoked vestibulodynia/symptoms of vestibulodynia for three months or more or have been received the diagnosis vestibulodynia
* access to the internet
* 18 years old or older
* good knowledge of Swedish (since the material will be in Swedish)

Exclusion Criteria:

* suffer from serious psychological problems that requires clinical care or problems with addiction
* involved in an ongoing psychological treatment
* scheduled activity that will impede the participant to participate in the treatment

Primary outcomes:
measure: Female sexual function index
timeFrame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
measure: Female sexual distress-scale
timeFrame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Secondary outcomes:
measure: Brunnsviken Brief Quality of Life Inventory (BBQ)
timeFrame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
measure: Pain severity scale in Multidimensional Pain Inventory (MPI)
timeFrame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
measure: Montgomery Åsberg Depression Rating Scale (MADRS-S)
timeFrame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
measure: Vaginal penetration cognition questionnaire (VPCQ)
timeFrame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
measure: Chronic pain acceptance questionnaire (CPAQ)
timeFrame: Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
measure: Committed Action Questionnaire-8 (CAQ-8)
timeFrame: Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
measure: Treatment credibility scale (TCS)
timeFrame: After the first treatment week
measure: CHAMP Sexual Pain Coping Scale (CSPCS),
timeFrame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
measure: Quality of dyadic relationship (QDR-36)
timeFrame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of psycholology, Uppsala university
state: Uppland
Study officials:
affiliation: Uppsala University
name: Monica Buhrman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Lance McCracken, Professor
role: STUDY_CHAIR
References: