Internet-based Treatment for Provoked Vestibulodynia
Primary Purpose
Provoked Vestibulodynia, Vulvodynia, Generalized
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Acceptance and commitment therapy
Sponsored by
About this trial
This is an interventional treatment trial for Provoked Vestibulodynia focused on measuring Provoked vestibulodynia, Exposure treatment, Cognitive behaviour therapy, Acceptance and commitment therapy, Pain, Internet-based, Vulvodynia
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
Sites / Locations
- Department of psycholology, Uppsala university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control group
Arm Description
10 week internet-based acceptance and commitment therapy
Waiting-list control.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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).
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.
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
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.
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).
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.
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.
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.
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04045041
Brief Title
Internet-based Treatment for Provoked Vestibulodynia
Official Title
A Guided Internet-based CBT Treatment for Provoked Vestibulodynia:a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Provoked Vestibulodynia, Vulvodynia, Generalized
Keywords
Provoked vestibulodynia, Exposure treatment, Cognitive behaviour therapy, Acceptance and commitment therapy, Pain, Internet-based, Vulvodynia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
10 week internet-based acceptance and commitment therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Waiting-list control.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and commitment therapy
Intervention Description
An acceptance based intervention with focus on exposure.
Primary Outcome Measure Information:
Title
Female sexual function index
Description
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
Time Frame
Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Title
Female sexual distress-scale
Description
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
Time Frame
Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Secondary Outcome Measure Information:
Title
Brunnsviken Brief Quality of Life Inventory (BBQ)
Description
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).
Time Frame
Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Title
Pain severity scale in Multidimensional Pain Inventory (MPI)
Description
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.
Time Frame
Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Title
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Description
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
Time Frame
Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Title
Generalised Anxiety Disorder 7-item scale (GAD-7)
Description
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.
Time Frame
Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Title
Vaginal penetration cognition questionnaire (VPCQ)
Description
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).
Time Frame
Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Title
Chronic pain acceptance questionnaire (CPAQ)
Description
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.
Time Frame
Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
Title
Committed Action Questionnaire-8 (CAQ-8)
Description
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.
Time Frame
Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
Title
Mindful Attention Awareness Scale (MAAS)
Description
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.
Time Frame
Baseline-, mid-(week 5), post-(at 10 weeks) and follow up- measure (6months)
Title
Treatment credibility scale (TCS)
Description
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.
Time Frame
After the first treatment week
Title
CHAMP Sexual Pain Coping Scale (CSPCS),
Description
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
Time Frame
Baseline-, post-(at 10 weeks) and follow up- measure (6months)
Title
Quality of dyadic relationship (QDR-36)
Description
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.
Time Frame
Baseline-, post-(at 10 weeks) and follow up- measure (6months)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study was aimed at individuals with a vagina since it is a treatment for vestibulodynia.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Buhrman, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lance McCracken, Professor
Organizational Affiliation
Uppsala University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of psycholology, Uppsala university
City
Uppsala
State/Province
Uppland
ZIP/Postal Code
75237
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Internet-based Treatment for Provoked Vestibulodynia
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