Provoked VestibulodyniaNCT04045041
Internet-based Treatment for Provoked Vestibulodynia
A study testing Acceptance and commitment therapy in people with Provoked Vestibulodynia and Vulvodynia, Generalized, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Provoked Vestibulodynia, Vulvodynia, Generalized
- What is being tested?
- Acceptance and commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jan 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of psycholology, Uppsala university
Uppsala, Uppland, 75237
About this study
Official title: A Guided Internet-based CBT Treatment for Provoked Vestibulodynia:a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Acceptance and commitment therapy
- Keywords
- Provoked vestibulodynia, Exposure treatment, Cognitive behaviour therapy, Acceptance and commitment therapy, Pain, Internet-based, Vulvodynia
- Medical subject headings
- Vulvodynia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyBehavioural
An acceptance based intervention with focus on exposure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 10 week internet-based acceptance and commitment therapy Receives: Behavioral: Acceptance and commitment therapy |
| Control group | No intervention | Waiting-list control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Secondary outcomes (11)
Brunnsviken Brief Quality of Life Inventory (BBQ)
BBQ has a total of 12 items covering six life areas: Leisure, View on life, Creativity, Learning, Friends and Friendship, and View on self. All items are scored using the same response format, consisting of a five-step Likert rating scale, visually scored 0-4 with written anchor points at 0 (Strongly disagree) and 4 (Strongly agree). The BBQ total score is computed by summing the weighted satisfaction ratings, i.e. by multiplying the Satisfaction and Importance items for each life area and summing the six products for a total score (possible score range 0-96).
Measured: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Pain severity scale in Multidimensional Pain Inventory (MPI)
The pain severity scale contains three items ranging from 0 to 6 (seven points) and measures pain intensity. The score is calculated by adding the score for each item divided by the number of items (scores range from 0-6). Higher scores indicate greater pain intensity.
Measured: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Montgomery Åsberg Depression Rating Scale (MADRS-S)
The Montgomery Åsberg Depression Rating Scale measures depression symptom with 9 items.The respondents rate their symptoms on a scale that ranges from 0 to 6, where a higher value indicates a higher level of depressive symptoms. The score can range from 0-54, higher scores indicate more severe depressive symptoms e.g. a score >35 indicates a severe depression. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts
Measured: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Generalised Anxiety Disorder 7-item scale (GAD-7)
Generalized Anxiety Disorder 7-item scale /GAD-7) measures anxiety with 7 items. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21.
Measured: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Vaginal penetration cognition questionnaire (VPCQ)
The Vaginal penetration cognition questionnaire (VPCQ) measures cognitions regarding vaginal penetration are assessed where the participant score in a likert scale ranging from 0-6 in 22 statements. Possible answers range from "0 = not at all applicable" to "6 = very strongly applicable." The VPCQ consists of 5 subscales: Control Beliefs (4 items), Catastrophic and Pain Beliefs (5 items), Self-Image Beliefs (6 items), Positive Beliefs (5 items), and Genital Incompatibility Beliefs (2 items).
Measured: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Chronic pain acceptance questionnaire (CPAQ)
Chronic pain acceptance questionnaire (CPAQ) measures with 20 items acceptance related to pain and an aspect of psychological flexibility. It is a process variable and consists of two subscales, Willingness and Engagement. Items are rated on a scale from 0 (never true) to 6 (always true).Higher scores denote greater activity engagement and pain willingness.The total score is also reported, higher scores is associated with higher levels of acceptance.
Measured: Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
Committed Action Questionnaire-8 (CAQ-8)
Committed Action Questionnaire (CAQ-8) measures commitment, an aspect of psychological flexibility. It is a process variable and consists of 8 items. lease rate the truth of each statement as it applies to you by circling a number. The rating scale ranges from 0(never true)to 6 (always true). The total score represents an individual's general propensity to persist in goal-directed behaviour, capturing both positive and negative aspects of the construct. Higher values indicating higher levels of committed action.
Measured: Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
Mindful Attention Awareness Scale (MAAS)
The Mindful Attention Awareness Scale (MAAS) is a 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present. Mindful attention awareness, an aspect of psychological flexibility. It is a process variable. The responder mark their response in a 1-6 scale and indicate how frequently or infrequently the person currently have each experience. To score the scale, the mean of the 15 items is calculated. Higher scores reflect higher levels of dispositional mindfulness.
Measured: Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
Treatment credibility scale (TCS)
The treatment credibility scale (TCS) measures how credible the treatment is perceived by the participant where the participant rates five statements. Every item i rated on a scale from 1 to 10, the last question is rated from 0% to 100%. The score is calculated by adding the score for each item.Higher values are associated with higher expectancy and credibility.
Measured: After the first treatment week
CHAMP Sexual Pain Coping Scale (CSPCS),
Sexual Pain Coping Scale (CSPCS) measure avoidance and endurance coping behaviors during penetration with 12-item. This measure consists of three sub-scales: avoidance, endurance and alternative strategies. Respondents rate their agreement of each statement between 1 ("Never true") and 7 ("Always true"). Total scores range from 4-28 on each sub-scale.12 items that measures cognitions and emotions related to sex and sexual pain
Measured: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Quality of dyadic relationship (QDR-36)
Measures 5 dimensions (Dyadic Consensus, Dyadic Satisfaction, Dyadic Sensuality, Dyadic Cohesion and Dyadic Sexuality)of a relationship with 36 items. Answers are rated in a scale that ranges from 1-6, an average score is calculated for every dimension. The average in every dimension is summed and an index is calculated which ranges from 5-30. The quota for the total questionnaire ranges from 6 to 1. Higher scores indicate good perceived quality in the relationship while lower scores indicate lower quality in the relationship.
Measured: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start20 Jan 2019
- Primary completion30 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Provoked VestibulodyniaStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Buhrman, Uppsala University
- Investigators
- Monica Buhrman, PhD, Principal investigator, Uppsala UniversityLance McCracken, Professor, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045041
- Sponsor's protocol ID
- 20180501
- Status last verified
- Dec 2022
- First submitted
- 1 Aug 2019
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Guided Internet-based CBT Treatment for Provoked Vestibulodynia:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04045041
- Acronym / sponsor ID
- 20180501
- Conditions
- Provoked Vestibulodynia, Vulvodynia, Generalized
- Keywords
- Provoked vestibulodynia, Exposure treatment, Cognitive behaviour therapy, Acceptance and commitment therapy, Pain, Internet-based, Vulvodynia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Acceptance and commitment therapy10 week internet-based acceptance and commitment therapy |
| Control group | No intervention | –Waiting-list control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and commitment therapyAn acceptance based intervention with focus on exposure. | Behavioural | Treatment group |
Primary outcome
Female sexual function index
Time frame: 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
Time frame: 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
11 secondary outcomes
Brunnsviken Brief Quality of Life Inventory (BBQ)
Time frame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Pain severity scale in Multidimensional Pain Inventory (MPI)
Time frame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Time frame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Vaginal penetration cognition questionnaire (VPCQ)
Time frame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Chronic pain acceptance questionnaire (CPAQ)
Time frame: Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
Committed Action Questionnaire-8 (CAQ-8)
Time frame: Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
Treatment credibility scale (TCS)
Time frame: After the first treatment week
CHAMP Sexual Pain Coping Scale (CSPCS),
Time frame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Quality of dyadic relationship (QDR-36)
Time frame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Buhrman, PhD principal investigator
Uppsala University
Lance McCracken, Professor study chair
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy in people with Provoked Vestibulodynia and Vulvodynia, Generalized, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female sexual function index (time frame: Baseline-, post-(at 10 weeks) and follow up- measure (6months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.