VestibulodyniaNCT01582373
Pilot Study to Assess the Efficacy of Cognitive-behavioral Couple Therapy for Provoked Vestibulodynia
A study testing Cognitive-behavioral couple therapy in people with Vestibulodynia, run by Université de Montréal at 1 site in Canada.
Trial summary
The current pilot study aims to assess the feasibility and preliminary efficacy of a novel, 12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Vestibulodynia
- What is being tested?
- Cognitive-behavioral couple therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Dec 2014
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- pain during intercourse which is a) subjectively distressing, b) occurs on 80% of intercourse attempts, and c) has lasted for at least one year
- pain limited to intercourse and other activities involving pressure to the vestibule
- significant pain in one or more locations of the vestibule during the gynaecological exam, which is operationalized as a minimum average patient pain rating of 4 on a scale of 0 to 10
- having been sexually active as a couple in the last three months (intercourse, manual or oral stimulation)
- in a committed relationship for at least six months
Who cannot join
- vulvar pain not clearly linked to intercourse or pressure applied to the vestibule
- presence of one of the following: a) major medical and/or psychiatric illness, b) active infection, c) deep dyspareunia, d) vaginismus (as defined by DSM-IV), e) dermatologic lesion, f) pregnancy or planning a pregnancy
- age less than 18 or greater than 45
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Assess the Efficacy of an Experimental 12-week Cognitive-behavioral Couple Therapy in the Treatment of Provoked Vestibulodynia
The current pilot study aims to assess the feasibility and preliminary efficacy of a novel, 12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners.
Read the detailed description
Chronic pain problems involving the female reproductive system are major health concerns in women of all ages. As conditions which are poorly understood, they entail a great personal cost to patients and a significant financial cost to society. One such condition is vulvodynia, or chronic unexplained vulvar pain, which has a prevalence of 16%. Despite its negative impact on psychosexual and relationship satisfaction, there has been a paucity of research to provide empirically validated treatments for afflicted couples. The proposed research draws on findings from our work focusing on the influence of romantic relationships in the experience of vulvodynia as well as on our past studies evaluating the efficacy of group cognitive-behavioral therapy for this problem. The proposed pilot study aims to assess the feasibility and preliminary efficacy of a novel, 12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners. The primary research question is: Is there a significant difference between pre- and post-treatment measures of pain during intercourse? We hypothesize that CBCT will yield pain reduction from pre- to post-treatment. The secondary research question focuses on pre- and post-treatment differences in 1) the multidimensional aspects of pain, 2) sexuality outcomes, 3) psychological adjustment, 4) relationship factors, and 5) patient self-reported improvement and treatment satisfaction. We hypothesize that the CBCT will result in significantly greater improvements on all outcome measures, and that the intervention will demonstrate adequate feasibility. Results of this study may improve the health and quality of life of patients afflicted with vulvodynia by helping us further develop this intervention for future clinical trial testing. For exploratory purposes, a 3-month follow-up assessment of treatment outcomes will also be conducted.
This pilot trial addresses the urgent need for empirically validated treatments for vulvodynia, and will help refine an intervention for future clinical trial testing. Results may improve the health and quality of life of couples afflicted with this highly prevalent women's health care problem. Findings will generate information about the feasibility and preliminary efficacy of a frequently recommended intervention for PVD, counselling targeting the couple. The findings will help provide women with PVD and their partners with scientifically based treatment options and may allow them to reduce the pain experienced during intercourse, in addition to improving their sexual functioning, overall well-being, and romantic relationship.
- Conditions
- Vestibulodynia
- Being tested
- Cognitive-behavioral couple therapy
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral couple therapyBehavioural
Also called Cognitive Behavioral Pain and Sex Therapy (CBPST)
The treatment package will include the following: information about the nature of CBCT; education about PVD and how it impacts on sexuality; education concerning a multifactorial view of pain; relaxation techniques; vaginal dilatation exercises; cognitive restructuring exercises (replacing distorted or irrational beliefs about pain and sexuality by more realistic ones); distraction techniques focusing on sexual imagery; expansion of the sexual repertoire; and exercises to improve pain and sexuality-relevant couple interactions (e.g., communication skills training, modification of maladaptive partner responses to pain, emotional disclosure and validation exercises).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral couple therapy | Experimental | The goals of CBCT are to enable participants to: (1) re-conceptualize PVD as a multidimensional pain problem influenced by a variety of factors including thoughts, emotions, behaviors and couple interactions; (2) re-conceptualize PVD as a couple problem in which both members of the couple affect and are affected by the pain; (3) modify those factors associated with pain during intercourse with a view to increasing adaptive coping, for example, by increasing self-efficacy and decreasing catastrophizing, as well as decreasing pain intensity; (4) improve the quality of their sexual functioning, reduce their sexual distress and increase their sexual satisfaction; (5) consolidate skills. Receives: Behavioral: Cognitive-behavioral couple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during intercourse (Visual analog scale)
Pain during intercourse will be assessed using a visual analog scale (VAS) ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever. The main outcome will be the change in the VAS scores from pre- to post-treatment. This method for measuring pain has been shown to detect significant treatment effects in women with PVD and demonstrates a significant positive correlation with other pain intensity measures. Pain during intercourse is the main symptom of PVD and the one that most interferes with quality of life, hence the most relevant measure of functional outcome.
Measured: change in the VAS scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Secondary outcomes (9)
Sexual function (Derogatis Interview for Sexual Functioning - Self-Report)
Sexual function will be assessed using the Derogatis Interview for Sexual Functioning - Self-Report (DISF-SR), which is a 25-item self-report version of a semi-structured interview designed to assess sexual function for both men and women. It measures five dimensions of sexuality: sexual cognition/fantasy, sexual arousal, sexual behavior/experience, orgasm, and sexual drive/relationship. Scores can be calculated for each dimension and for global sexual functioning. The DISF-SR boasts good internal consistency and reliability, specifically with women experiencing sexual dysfunction.
Measured: change in the DISF-SR scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Global Measure of Sexual Satisfaction scale
Sexual satisfaction will be assessed using the Global Measure of Sexual Satisfaction scale, which consists of 5 items assessing global sexual satisfaction. Internal consistency of this scale is high (alpha = 0.90), as is test-retest reliability (r = 0.84) (Lawrance \& Byers, 1998).
Measured: change in GMSEX scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
West Haven-Yale Multidimensional Pain Inventory - Significant Other Response Scale (MPI)
Partner responses from the point of view of the women with PVD and their partners will be measured with the West Haven-Yale Multidimensional Pain Inventory - Significant Other Response Scale (MPI) (Kerns, Turk, \& Rudy, 1985), and the Spouse Response Inventory - Facilitative subscale (SRI; (L. Schwartz, Mark P. Jensen, \& Joan M. Romano, 2005) which have been adapted to our population of women with PVD and their partners.
Measured: changes in MPI scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Couple Satisfaction Index (CSI)
Couple Satisfaction, or dyadic adjustment will be measured with the Couple Satisfaction Index (CSI). The CSI (Funk \& Rogge, 2007) is a 32-item measure of relationship satisfaction. Compared to other well-known relationship satisfaction measures (e.g., Dyadic Adjustment Scale; Spanier, 1976; and the Marital Adjustment Test; Locke \& Wallace, 1959) it demonstrates strong convergent validity, and a higher precision and power for detecting distinctions in satisfaction levels (Funk \& Rogge, 2007).
Measured: changes in CSI scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Pain Catastrophizing Scale (PCS)
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (Sullivan, Bishop, \& Pivik, 1995), which consists of 13 items measuring exaggerated negative thoughts and feelings about the meaning of pain. Items are scored on a 5-point scale with the end points (0) not at all and (4) all the time. The PCS is a reliable and valid measure that has demonstrated a stable factorial structure across clinical and general populations, including a French population (French et al., 2005; Osman et al., 2000; Sullivan, et al., 1995).
Measured: changes in PSC scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
Spielberger State-Trait Anxiety Inventory (STAI)
Anxiety will be assessed using the Spielberger State-Trait Anxiety Inventory (STAI - (Spielberger, Gorsuch, \& Lushene, 1970); ASTA - (Gauthier \& Bouchard, 1993)). The STAI is a 40-item, well-known and widely used measure of state and trait anxiety that has demonstrated very good psychometric properties (Cronbach's alpha State = .93, Trait = .97) in various clinical and non-clinical samples including pain populations (Gauthier \& Bouchard, 1993; Greenberg \& Burns, 2003; Rule \& Traver, 1983; Tanaka-Masumi \& Kameoka, 1986).
Measured: changes in STAI from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
Self-reported improvement and satisfaction
Patient self-reported improvement [scale of 0 (completely dissatisfied) to 10 (completely satisfied)] and treatment satisfaction [scale of 0 (worse) to 5 (complete cure)] will be measured at the post-treatment structured interview in order to assess the clinical significance of results.
Measured: Reported at the end of treatment
Painful Intercourse Self-Efficacy Scale (PISES)
Pain self-efficacy will be assessed using the Painful Intercourse Self-Efficacy Scale (PISES; (Desrochers, et al., 2009), which was adapted from the Arthritis Self-Efficacy Scale (Lorig, Chastain, Ung, Shoor, \& Holman, 1989). The PISES consists of 20 items with three subscales: self-efficacy for controlling pain during intercourse, self-efficacy for sexual function, and self-efficacy for controlling other symptoms.
Measured: Changes in PISES scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
Beck Depression Inventory (BDI-II)
Depression or depression symptoms will be measured with the Beck Depression Inventory-II (BDI-II). The BDI-II is comprised of 21 items, with scores for most items ranging from 0 (low intensity) to 3 (high intensity) (Beck, Steer \& Brown, 1996; Beck, Steer \& Garvin, 1988). This measure of depression has been validated for use in chronic pain populations (Turner \& Romano, 1984).
Measured: changes in BDI-II scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VestibulodyniaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Bergeron, Université de Montréal
- Investigators
- Sophie Bergeron, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582373
- Sponsor's protocol ID
- CBCT-01
- Other IDs
- 274271
- Status last verified
- Dec 2014
- First submitted
- 19 Apr 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Efficacy of an Experimental 12-week Cognitive-behavioral Couple Therapy in the Treatment of Provoked Vestibulodynia
- ClinicalTrials.gov ID
- NCT01582373
- Acronym / sponsor ID
- CBCT-01
- Conditions
- Vestibulodynia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Apr 2012 (estimated)
- 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.
The current pilot study aims to assess the feasibility and preliminary efficacy of a novel, 12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners.
Detailed description
Chronic pain problems involving the female reproductive system are major health concerns in women of all ages. As conditions which are poorly understood, they entail a great personal cost to patients and a significant financial cost to society. One such condition is vulvodynia, or chronic unexplained vulvar pain, which has a prevalence of 16%. Despite its negative impact on psychosexual and relationship satisfaction, there has been a paucity of research to provide empirically validated treatments for afflicted couples. The proposed research draws on findings from our work focusing on the influence of romantic relationships in the experience of vulvodynia as well as on our past studies evaluating the efficacy of group cognitive-behavioral therapy for this problem. The proposed pilot study aims to assess the feasibility and preliminary efficacy of a novel, 12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners. The primary research question is: Is there a significant difference between pre- and post-treatment measures of pain during intercourse? We hypothesize that CBCT will yield pain reduction from pre- to post-treatment. The secondary research question focuses on pre- and post-treatment differences in 1) the multidimensional aspects of pain, 2) sexuality outcomes, 3) psychological adjustment, 4) relationship factors, and 5) patient self-reported improvement and treatment satisfaction. We hypothesize that the CBCT will result in significantly greater improvements on all outcome measures, and that the intervention will demonstrate adequate feasibility. Results of this study may improve the health and quality of life of patients afflicted with vulvodynia by helping us further develop this intervention for future clinical trial testing. For exploratory purposes, a 3-month follow-up assessment of treatment outcomes will also be conducted.
This pilot trial addresses the urgent need for empirically validated treatments for vulvodynia, and will help refine an intervention for future clinical trial testing. Results may improve the health and quality of life of couples afflicted with this highly prevalent women's health care problem. Findings will generate information about the feasibility and preliminary efficacy of a frequently recommended intervention for PVD, counselling targeting the couple. The findings will help provide women with PVD and their partners with scientifically based treatment options and may allow them to reduce the pain experienced during intercourse, in addition to improving their sexual functioning, overall well-being, and romantic relationship.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral couple therapy | Experimental | Behavioral: Cognitive-behavioral couple therapyThe goals of CBCT are to enable participants to: (1) re-conceptualize PVD as a multidimensional pain problem influenced by a variety of factors including thoughts, emotions, behaviors and couple interactions; (2) re-conceptualize PVD as a couple problem in which both members of the couple affect and are affected by the pain; (3) modify those factors associated with pain during intercourse with a view to increasing adaptive coping, for example, by increasing self-efficacy and decreasing catastrophizing, as well as decreasing pain intensity; (4) improve the quality of their sexual functioning, reduce their sexual distress and increase their sexual satisfaction; (5) consolidate skills. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pain during intercourse which is a) subjectively distressing, b) occurs on 80% of intercourse attempts, and c) has lasted for at least one year
- pain limited to intercourse and other activities involving pressure to the vestibule
- significant pain in one or more locations of the vestibule during the gynaecological exam, which is operationalized as a minimum average patient pain rating of 4 on a scale of 0 to 10
- having been sexually active as a couple in the last three months (intercourse, manual or oral stimulation)
- in a committed relationship for at least six months
Key exclusion criteria (3 listed)
- vulvar pain not clearly linked to intercourse or pressure applied to the vestibule
- presence of one of the following: a) major medical and/or psychiatric illness, b) active infection, c) deep dyspareunia, d) vaginismus (as defined by DSM-IV), e) dermatologic lesion, f) pregnancy or planning a pregnancy
- age less than 18 or greater than 45
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 |
|---|---|---|
| Cognitive-behavioral couple therapyAlso: Cognitive Behavioral Pain and Sex Therapy (CBPST)The treatment package will include the following: information about the nature of CBCT; education about PVD and how it impacts on sexuality; education concerning a multifactorial view of pain; relaxation techniques; vaginal dilatation exercises; cognitive restructuring exercises (replacing distorted or irrational beliefs about pain and sexuality by more realistic ones); distraction techniques focusing on sexual imagery; expansion of the sexual repertoire; and exercises to improve pain and sexuality-relevant couple interactions (e.g., communication skills training, modification of maladaptive partner responses to pain, emotional disclosure and validation exercises). | Behavioural | Cognitive-behavioral couple therapy |
Primary outcome
Pain during intercourse (Visual analog scale)
Time frame: change in the VAS scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Pain during intercourse will be assessed using a visual analog scale (VAS) ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever. The main outcome will be the change in the VAS scores from pre- to post-treatment. This method for measuring pain has been shown to detect significant treatment effects in women with PVD and demonstrates a significant positive correlation with other pain intensity measures. Pain during intercourse is the main symptom of PVD and the one that most interferes with quality of life, hence the most relevant measure of functional outcome.
9 secondary outcomes
Sexual function (Derogatis Interview for Sexual Functioning - Self-Report)
Time frame: change in the DISF-SR scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Global Measure of Sexual Satisfaction scale
Time frame: change in GMSEX scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
West Haven-Yale Multidimensional Pain Inventory - Significant Other Response Scale (MPI)
Time frame: changes in MPI scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Couple Satisfaction Index (CSI)
Time frame: changes in CSI scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
Pain Catastrophizing Scale (PCS)
Time frame: changes in PSC scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: changes in STAI from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
Self-reported improvement and satisfaction
Time frame: Reported at the end of treatment
Painful Intercourse Self-Efficacy Scale (PISES)
Time frame: Changes in PISES scores from pre-to post-treatment, and from pre-treatment to 3-month post-treatment
Beck Depression Inventory (BDI-II)
Time frame: changes in BDI-II scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment
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 3 Dec 2014.
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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.
Sophie Bergeron, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral couple therapy in people with Vestibulodynia, run by Université de Montréal at 1 site in Canada.
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 5 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 3 Dec 2014. 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 Canada. 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?
Pain during intercourse (Visual analog scale) (time frame: change in the VAS scores from pre- to post-treatment, and from pre-treatment to 3-month post-treatment). 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 3 Dec 2014.