Internet-based Treatment for Provoked Vestibulodynia

NCT04045041 | Completed

• 1 other identifier: 20180501
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Provoked Vestibulodynia; Vulvodynia, Generalized

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Female sexual function index

  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

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

• Female sexual distress-scale

  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

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

Secondary Outcomes (11)

• 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)

• Generalised Anxiety Disorder 7-item scale (GAD-7)

  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)

Study Arms (2)

Treatment group

EXPERIMENTAL

10 week internet-based acceptance and commitment therapy

Behavioral: Acceptance and commitment therapy

Control group

NO INTERVENTION

Waiting-list control.

Interventions

Acceptance and commitment therapy BEHAVIORAL

An acceptance based intervention with focus on exposure.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study was aimed at individuals with a vagina since it is a treatment for vestibulodynia.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Department of psycholology, Uppsala university

Uppsala, Uppland, 75237, Sweden

Location

MeSH Terms

Conditions

Vulvodynia; Pain

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Monica Buhrman, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

• Lance McCracken, Professor

  Uppsala University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, licensed psychologist & psychotherapist

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: January 20, 2019
• Primary Completion: December 30, 2020
• Study Completion: June 30, 2021
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

SE (1)