Internet-based Treatment for Provoked Vestibulodynia

NCT ID: NCT04045041

Last Updated: 2022-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-20
• Study Completion Date: 2021-06-30

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.

Conditions

Provoked Vestibulodynia; Vulvodynia, Generalized

Keywords

Provoked vestibulodynia; Exposure treatment; Cognitive behaviour therapy; Acceptance and commitment therapy; Pain; Internet-based; Vulvodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

10 week internet-based acceptance and commitment therapy

Group Type: EXPERIMENTAL

Acceptance and commitment therapy

Intervention Type: BEHAVIORAL

An acceptance based intervention with focus on exposure.

Control group

Waiting-list control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acceptance and commitment therapy

An acceptance based intervention with focus on exposure.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Monica Buhrman

PhD, licensed psychologist & psychotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica Buhrman, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Lance McCracken, Professor

Role: STUDY_CHAIR

Uppsala University

Locations

Department of psycholology, Uppsala university

Uppsala, Uppland, Sweden

Countries

Sweden

Other Identifiers

20180501

Identifier Type: -

Identifier Source: org_study_id