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临床试验/NCT04045041
NCT04045041已完成不适用

A Guided Internet-based CBT Treatment for Provoked Vestibulodynia:a Randomized Controlled Trial

Uppsala University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Female sexual function index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Female sexual function index

时间窗: Baseline-, post-(at 10 weeks) and follow up- measure (6months)

It measures sexual dysfunction with 19 items. The answers are rated in a likert scale ranging from 0-5 regarding sexual activity. The results are presented in one total scale

Female sexual distress-scale

时间窗: Baseline-, post-(at 10 weeks) and follow up- measure (6months)

It measures distress related to sexual function with 13 items and an additional question. The answers are rated from Always, Often, Sometimes, Rarely and Never. The results are presented in one total scale

次要结局

  • Generalised Anxiety Disorder 7-item scale (GAD-7)(Baseline-, post-(at 10 weeks) and follow up- measure (6months))
  • Chronic pain acceptance questionnaire (CPAQ)(Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months))
  • Treatment credibility scale (TCS)(After the first treatment week)
  • CHAMP Sexual Pain Coping Scale (CSPCS),(Baseline-, post-(at 10 weeks) and follow up- measure (6months))
  • Quality of dyadic relationship (QDR-36)(Baseline-, post-(at 10 weeks) and follow up- measure (6months))
  • Brunnsviken Brief Quality of Life Inventory (BBQ)(Baseline-, post-(at 10 weeks) and follow up- measure (6months))
  • Pain severity scale in Multidimensional Pain Inventory (MPI)(Baseline-, post-(at 10 weeks) and follow up- measure (6months))
  • Montgomery Åsberg Depression Rating Scale (MADRS-S)(Baseline-, post-(at 10 weeks) and follow up- measure (6months))
  • Vaginal penetration cognition questionnaire (VPCQ)(Baseline-, post-(at 10 weeks) and follow up- measure (6months))
  • Committed Action Questionnaire-8 (CAQ-8)(Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months))
  • Mindful Attention Awareness Scale (MAAS)(Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months))

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Monica Buhrman

PhD, licensed psychologist & psychotherapist

Uppsala University

研究点 (2)

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