Provoked Vestibulodynia
Conditions
Keywords
provoked vestibulodynia, dyspareunia, vulvodynia, mindfulness, cognitive behavioural therapy
Brief summary
This randomized trial, nicknamed the COMFORT (Cognitive therapy or Mindfulness FOR Treatment of pvd) study, will compare the effects of an 8-session group Mindfulness-based Cognitive Therapy (MBCT) to an 8-session group Cognitive Behavioural Therapy (CBT) for women with provoked vestibulodynia (PVD). Women with PVD will be randomly assigned to attend either eight sessions of group MBCT or CBT. Each session is 2.25 hours long and spaced 1 week apart. The purpose of this study is to determine whether the 8-session MBCT intervention for PVD is no worse than an 8-session CBT intervention for decreasing women's pain intensity, sexual distress, catastrophizing and hypervigilance towards pain.
Detailed description
PURPOSE: The purpose of this study is to determine whether an 8-session MBCT intervention for PVD is no worse than an 8-session CBT intervention for improving women's pain intensity and reducing their sexual distress, catastrophizing and hypervigilance towards pain. The investigators will also examine whether pain improvements at follow-up are mediated by changes in self-compassion and mindfulness (in the MBCT arm only) and moderated by pre-treatment credibility, personality, and anxiety sensitivity. HYPOTHESES: 1. At follow-up (4 weeks, 6 months and 12 months post-treatment), women in the MBCT arm will experience a greater decline (vs. pre-treatment) in vestibular pain intensity compared to women in the CBT arm. 2. At follow-up (4 weeks, 6 months and 12 months post-treatment), women in the MBCT arm will experience a greater decline (vs. pre-treatment) in sex-related distress, pain catastrophizing, hypervigilance, and self-reported pain during intercourse/other penetrative sex compared to women in the CBT arm. 3. The investigators hypothesize that improvements in pain intensity during vestibular touch will be mediated by changes in self-compassion and mindfulness in the MBCT arm only at 6 and 12 months follow-up. 4. The investigators hypothesize that pre-treatment credibility, personality, and anxiety sensitivity will significantly moderate improvements in pain intensity during vestibular touch at 6 and 12 months follow-up. 5. The investigators hypothesize improvements in both arms on the Patient Global Impression of Change Scale and significantly greater improvements in the MBCT arm relative to the CBT arm at follow-up (4 weeks, 6 months and 12 months post-treatment).
Interventions
BEHAVIORALMindfulness-based Cognitive Therapy
The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.
BEHAVIORALCognitive Behavioural Therapy
The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of provoked vestibulodynia (PVD) * 19 years of age or older * premenopausal * fluent in English * during the study, women must agree not to change any medications they are taking for PVD.
Exclusion criteria
* unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain * being uncomfortable and unwilling to participate in a group setting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment | Pre-treatment, one month post-treatment and 6 months post-treatment. | The investigators have selected pain intensity during a controlled examination as the primary endpoint in this study. Specifically, pain intensity at the vulvar vestibule will be assessed using a vulvalgesiometer. The vulvalgesiometer is an instrument that provides a measure of pain/sensitivity that can be standardized across time points. The vulvalgesiometer is calibrated to exert a fixed amount of pressure. In this study, 30 grams of pressure at the 1, 3, 4, 6, 8, 9, and 11 o'clock positions (randomly) around the vestibule will be applied using the vulvalgestiometer. Women will also report their pain at each site using a numeric rating scale from 0 (no pain) to 10 (worst pain ever). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Function | Pre-treatment, one month post-treatment, and 6 months post-treatment. | The investigators will examine women's self-reported sexual function by administering the Female Sexual Function Index (FSFI). The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire which assesses sexual function in women. It covers six sexual domains: lubrication, arousal, desire, pain, orgasm and satisfaction. Scores range from 7.2 - 36 where increase in sexual dysfunction is represented by lower scores. Subscales: Desire- 2, 3 \[Subscale scores Range: 1.2 - 6\] Arousal- 5,6,7,8 \[Subscale Scores Range: 1.2 - 6\] Lubrication- 9,10,11,12 \[Subscale Scores Range: 1.2 - 6\] Orgasm- 13, 14, 15 \[Subscale Scores Range: 1.2 - 6\] Satisfaction- 1, 16, 17 \[Subscale Scores Range: 1.2 - 6\] Pain- 18, 19, 20 \[Subscale Scores Range: 1.2 - 6\] Extra item: (4) have you been sexually active in past 4 weeks? (yes/no) \[Scores Range 0 (no) - 1 (yes)\] Note: Ranges applicable only if question 4 was answered yes. |
| Sexual Distress | Pre-treatment, one month post-treatment, and 6 months post-treatment. | The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised. This is a 12-item self-report questionnaire assessing for sexuality related personal distress. Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress. |
| Pain Catastrophizing | Pre-treatment, one month post-treatment, and 6 months post-treatment.. | The investigators will examine women's self-reported pain catastrophizing by administering the Pain Catastrophizing Scale. The Pain Catastrophizing Scale (PCS) is a self-report questionnaire that asks participants to think about past painful experiences, or a specific experience of pain, and to indicate the degree to which they have any of the presented thoughts or feelings when they are experiencing pain. Each one of the 13-items is rated on a Likert scale from 0 (not at all) to 4 (all the time), where a higher total score indicates higher pain catastrophizing. Subscales: Rumination- (4 items) 8, 9, 10, and 11 \[Scores Range: 0 - 16\] Magnification- (3 items) 6, 7, and 13 \[Scores Range: 0 - 12\] Helplessness- (6 items) 1, 2, 3, 4, 5, and 12 \[Scores Range: 0 - 24\] Sum of all items \[Overall Range: 0 - 52\] |
| Self-reported Pain During Penetration | Pre-treatment,one month post-treatment, and 6 months follow-up. | The investigators will measure self-report of pain during attempted or completed intercourse (or dildo entry for non-heterosexual women). Numeric Rating Scale that asked participants to rate the intensity of pain during vaginal penetration attempts with sexual intercourse or penetration over the past 4 weeks This question was rated on a 0 to 10 scale from no pain (0) to worst possible pain (10). |
| Chronic Pain Acceptance, Activities Engagement | Pre-treatment, one month post-treatment, and 6 months post-treatment. | The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains, Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance. Subscales: Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 \[Scores Range: 0 - 66\] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 \[Scores Range: 0 - 54\] |
| Chronic Pain Acceptance, CPAQ Pain Willingness | Pre-treatment, one month post-treatment, and 6 months post treatment. | The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains: Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance. Subscales: Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 \[Scores Range: 0 - 66\] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 \[Scores Range: 0 - 54\] |
| Pain Hypervigilance | Pre-treatment, one month post-treatment, and 6 months post treatment. | The investigators will examine women's self-reported hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire. The Pain Vigilance and Awareness Questionnaire (PVAQ) is a 16 item self-report measure to assess the awareness, vigilance, preoccupation and observation of pain. Sum total score \[Scores Range: 0 - 80\]. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain. | 67 |
| Cognitive Behavioural Therapy (CBT) Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training. | 63 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 14 |
Baseline characteristics
| Characteristic | Total | Cognitive Behavioural Therapy (CBT) | Mindfulness-based Cognitive Therapy (MBCT) |
|---|---|---|---|
| Age, Continuous | 32.35 years STANDARD_DEVIATION 8.21 | 31.24 years STANDARD_DEVIATION 8.99 | 33.72 years STANDARD_DEVIATION 7.48 |
| Education High School | 3 participants | 2 participants | 1 participants |
| Education Post-Graduate | 30 participants | 13 participants | 17 participants |
| Education Prefer Not To Answer | 15 participants | 7 participants | 8 participants |
| Education Some College | 27 participants | 17 participants | 10 participants |
| Education University Degree | 55 participants | 24 participants | 31 participants |
| Length of relationship | 7.67 years STANDARD_DEVIATION 7.52 | 7.56 years STANDARD_DEVIATION 6.79 | 7.77 years STANDARD_DEVIATION 6.16 |
| Level of typical pain (/10) | 6.00 units on a scale STANDARD_DEVIATION 1.96 | 5.96 units on a scale STANDARD_DEVIATION 2.11 | 6.04 units on a scale STANDARD_DEVIATION 1.82 |
| Level of worst pain (/10) | 8.23 units on a scale STANDARD_DEVIATION 1.21 | 8.23 units on a scale STANDARD_DEVIATION 1.32 | 8.23 units on a scale STANDARD_DEVIATION 1.1 |
| Past medications received | 19 participants | 11 participants | 8 participants |
| Past treatments received | 65 participants | 29 participants | 36 participants |
| PVD history Aquired | 50 Participants | 26 Participants | 24 Participants |
| PVD history Lifelong | 80 Participants | 37 Participants | 43 Participants |
| Race/Ethnicity, Customized Euro-Canadian | 84 participants | 38 participants | 46 participants |
| Race/Ethnicity, Customized Other | 21 participants | 12 participants | 9 participants |
| Race/Ethnicity, Customized Prefer Not To Answer | 4 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized South/East Asian | 21 participants | 11 participants | 10 participants |
| Relationship status Dating | 24 Participants | 13 Participants | 11 Participants |
| Relationship status Did Not Disclose | 1 Participants | 1 Participants | 0 Participants |
| Relationship status Married / Common Law | 86 Participants | 41 Participants | 45 Participants |
| Relationship status Single | 19 Participants | 8 Participants | 11 Participants |
| Satisfaction with relationship closeness (/10) | 7.52 units on a scale STANDARD_DEVIATION 2.15 | 7.79 units on a scale STANDARD_DEVIATION 1.99 | 7.26 units on a scale STANDARD_DEVIATION 2.29 |
| Sex: Female, Male Female | 130 Participants | 63 Participants | 67 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Years since diagnosis | 7.95 years STANDARD_DEVIATION 6.67 | 6.02 years STANDARD_DEVIATION 4.72 | 9.85 years STANDARD_DEVIATION 7.72 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment
The investigators have selected pain intensity during a controlled examination as the primary endpoint in this study. Specifically, pain intensity at the vulvar vestibule will be assessed using a vulvalgesiometer. The vulvalgesiometer is an instrument that provides a measure of pain/sensitivity that can be standardized across time points. The vulvalgesiometer is calibrated to exert a fixed amount of pressure. In this study, 30 grams of pressure at the 1, 3, 4, 6, 8, 9, and 11 o'clock positions (randomly) around the vestibule will be applied using the vulvalgestiometer. Women will also report their pain at each site using a numeric rating scale from 0 (no pain) to 10 (worst pain ever).
Time frame: Pre-treatment, one month post-treatment and 6 months post-treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment | pre-treatment | 6.66 score on a scale | Standard Deviation 2.17 |
| Mindfulness-based Cognitive Therapy (MBCT) | Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment | one month post-treatment | 3.21 score on a scale | Standard Deviation 1.96 |
| Mindfulness-based Cognitive Therapy (MBCT) | Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment | 6 months follow up | 2.92 score on a scale | Standard Deviation 2.31 |
| Cognitive Behavioural Therapy (CBT) | Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment | pre-treatment | 6.62 score on a scale | Standard Deviation 2.19 |
| Cognitive Behavioural Therapy (CBT) | Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment | one month post-treatment | 3.60 score on a scale | Standard Deviation 2.14 |
| Cognitive Behavioural Therapy (CBT) | Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment | 6 months follow up | 2.86 score on a scale | Standard Deviation 1.89 |
Secondary
Chronic Pain Acceptance, Activities Engagement
The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains, Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance. Subscales: Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 \[Scores Range: 0 - 66\] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 \[Scores Range: 0 - 54\]
Time frame: Pre-treatment, one month post-treatment, and 6 months post-treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | Chronic Pain Acceptance, Activities Engagement | Pre-Treatment | 42.40 score on a scale | Standard Deviation 10.91 |
| Mindfulness-based Cognitive Therapy (MBCT) | Chronic Pain Acceptance, Activities Engagement | One Month Post-Treatment | 47.97 score on a scale | Standard Deviation 10.26 |
| Mindfulness-based Cognitive Therapy (MBCT) | Chronic Pain Acceptance, Activities Engagement | 6 months follow up | 49.24 score on a scale | Standard Deviation 9.29 |
| Cognitive Behavioural Therapy (CBT) | Chronic Pain Acceptance, Activities Engagement | Pre-Treatment | 42.39 score on a scale | Standard Deviation 10.14 |
| Cognitive Behavioural Therapy (CBT) | Chronic Pain Acceptance, Activities Engagement | One Month Post-Treatment | 46.63 score on a scale | Standard Deviation 9.34 |
| Cognitive Behavioural Therapy (CBT) | Chronic Pain Acceptance, Activities Engagement | 6 months follow up | 47.83 score on a scale | Standard Deviation 8.7 |
Secondary
Chronic Pain Acceptance, CPAQ Pain Willingness
The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains: Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance. Subscales: Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 \[Scores Range: 0 - 66\] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 \[Scores Range: 0 - 54\]
Time frame: Pre-treatment, one month post-treatment, and 6 months post treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | Chronic Pain Acceptance, CPAQ Pain Willingness | Pre-Treatment | 23.99 score on a scale | Standard Deviation 9.29 |
| Mindfulness-based Cognitive Therapy (MBCT) | Chronic Pain Acceptance, CPAQ Pain Willingness | One Month Post-Treatment | 29.34 score on a scale | Standard Deviation 10.07 |
| Mindfulness-based Cognitive Therapy (MBCT) | Chronic Pain Acceptance, CPAQ Pain Willingness | 6 months follow up | 33.72 score on a scale | Standard Deviation 8.8 |
| Cognitive Behavioural Therapy (CBT) | Chronic Pain Acceptance, CPAQ Pain Willingness | Pre-Treatment | 22.91 score on a scale | Standard Deviation 8.05 |
| Cognitive Behavioural Therapy (CBT) | Chronic Pain Acceptance, CPAQ Pain Willingness | One Month Post-Treatment | 29.20 score on a scale | Standard Deviation 8.42 |
| Cognitive Behavioural Therapy (CBT) | Chronic Pain Acceptance, CPAQ Pain Willingness | 6 months follow up | 31.29 score on a scale | Standard Deviation 8.51 |
Secondary
Pain Catastrophizing
The investigators will examine women's self-reported pain catastrophizing by administering the Pain Catastrophizing Scale. The Pain Catastrophizing Scale (PCS) is a self-report questionnaire that asks participants to think about past painful experiences, or a specific experience of pain, and to indicate the degree to which they have any of the presented thoughts or feelings when they are experiencing pain. Each one of the 13-items is rated on a Likert scale from 0 (not at all) to 4 (all the time), where a higher total score indicates higher pain catastrophizing. Subscales: Rumination- (4 items) 8, 9, 10, and 11 \[Scores Range: 0 - 16\] Magnification- (3 items) 6, 7, and 13 \[Scores Range: 0 - 12\] Helplessness- (6 items) 1, 2, 3, 4, 5, and 12 \[Scores Range: 0 - 24\] Sum of all items \[Overall Range: 0 - 52\]
Time frame: Pre-treatment, one month post-treatment, and 6 months post-treatment..
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | Pain Catastrophizing | Pre-Treatment | 26.92 score on a scale | Standard Deviation 12.86 |
| Mindfulness-based Cognitive Therapy (MBCT) | Pain Catastrophizing | One Month Post-Treatment | 15.64 score on a scale | Standard Deviation 12.54 |
| Mindfulness-based Cognitive Therapy (MBCT) | Pain Catastrophizing | 6 months follow up | 11.55 score on a scale | Standard Deviation 9.91 |
| Cognitive Behavioural Therapy (CBT) | Pain Catastrophizing | Pre-Treatment | 25.62 score on a scale | Standard Deviation 11.97 |
| Cognitive Behavioural Therapy (CBT) | Pain Catastrophizing | One Month Post-Treatment | 12.57 score on a scale | Standard Deviation 8.13 |
| Cognitive Behavioural Therapy (CBT) | Pain Catastrophizing | 6 months follow up | 10.83 score on a scale | Standard Deviation 7.66 |
Secondary
Pain Hypervigilance
The investigators will examine women's self-reported hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire. The Pain Vigilance and Awareness Questionnaire (PVAQ) is a 16 item self-report measure to assess the awareness, vigilance, preoccupation and observation of pain. Sum total score \[Scores Range: 0 - 80\].
Time frame: Pre-treatment, one month post-treatment, and 6 months post treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | Pain Hypervigilance | Pre-Treatment | 43.24 score on a scale | Standard Deviation 14.67 |
| Mindfulness-based Cognitive Therapy (MBCT) | Pain Hypervigilance | One Month Post-Treatment | 39.74 score on a scale | Standard Deviation 13.72 |
| Mindfulness-based Cognitive Therapy (MBCT) | Pain Hypervigilance | 6 months follow up | 38.50 score on a scale | Standard Deviation 13.88 |
| Cognitive Behavioural Therapy (CBT) | Pain Hypervigilance | Pre-Treatment | 42.46 score on a scale | Standard Deviation 12.12 |
| Cognitive Behavioural Therapy (CBT) | Pain Hypervigilance | One Month Post-Treatment | 40.32 score on a scale | Standard Deviation 14.19 |
| Cognitive Behavioural Therapy (CBT) | Pain Hypervigilance | 6 months follow up | 38.76 score on a scale | Standard Deviation 14.47 |
Secondary
Self-reported Pain During Penetration
The investigators will measure self-report of pain during attempted or completed intercourse (or dildo entry for non-heterosexual women). Numeric Rating Scale that asked participants to rate the intensity of pain during vaginal penetration attempts with sexual intercourse or penetration over the past 4 weeks This question was rated on a 0 to 10 scale from no pain (0) to worst possible pain (10).
Time frame: Pre-treatment,one month post-treatment, and 6 months follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | Self-reported Pain During Penetration | Pre-treatment | 6.69 score on a scale | Standard Deviation 1.91 |
| Mindfulness-based Cognitive Therapy (MBCT) | Self-reported Pain During Penetration | One Month Post-Treatment | 4.34 score on a scale | Standard Deviation 2.22 |
| Mindfulness-based Cognitive Therapy (MBCT) | Self-reported Pain During Penetration | 6 months follow up | 3.39 score on a scale | Standard Deviation 1.89 |
| Cognitive Behavioural Therapy (CBT) | Self-reported Pain During Penetration | Pre-treatment | 5.86 score on a scale | Standard Deviation 2.13 |
| Cognitive Behavioural Therapy (CBT) | Self-reported Pain During Penetration | One Month Post-Treatment | 4.65 score on a scale | Standard Deviation 2.21 |
| Cognitive Behavioural Therapy (CBT) | Self-reported Pain During Penetration | 6 months follow up | 4.03 score on a scale | Standard Deviation 2.11 |
Secondary
Sexual Distress
The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised. This is a 12-item self-report questionnaire assessing for sexuality related personal distress. Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress.
Time frame: Pre-treatment, one month post-treatment, and 6 months post-treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | Sexual Distress | Pre-Treatment | 34.28 score on a scale | Standard Deviation 11.18 |
| Mindfulness-based Cognitive Therapy (MBCT) | Sexual Distress | One Month Post-Treatment | 26.60 score on a scale | Standard Deviation 13.35 |
| Mindfulness-based Cognitive Therapy (MBCT) | Sexual Distress | 6 months follow up | 22.81 score on a scale | Standard Deviation 12.98 |
| Cognitive Behavioural Therapy (CBT) | Sexual Distress | Pre-Treatment | 35.68 score on a scale | Standard Deviation 10.43 |
| Cognitive Behavioural Therapy (CBT) | Sexual Distress | One Month Post-Treatment | 24.93 score on a scale | Standard Deviation 91.31 |
| Cognitive Behavioural Therapy (CBT) | Sexual Distress | 6 months follow up | 23.77 score on a scale | Standard Deviation 9.61 |
Secondary
Sexual Function
The investigators will examine women's self-reported sexual function by administering the Female Sexual Function Index (FSFI). The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire which assesses sexual function in women. It covers six sexual domains: lubrication, arousal, desire, pain, orgasm and satisfaction. Scores range from 7.2 - 36 where increase in sexual dysfunction is represented by lower scores. Subscales: Desire- 2, 3 \[Subscale scores Range: 1.2 - 6\] Arousal- 5,6,7,8 \[Subscale Scores Range: 1.2 - 6\] Lubrication- 9,10,11,12 \[Subscale Scores Range: 1.2 - 6\] Orgasm- 13, 14, 15 \[Subscale Scores Range: 1.2 - 6\] Satisfaction- 1, 16, 17 \[Subscale Scores Range: 1.2 - 6\] Pain- 18, 19, 20 \[Subscale Scores Range: 1.2 - 6\] Extra item: (4) have you been sexually active in past 4 weeks? (yes/no) \[Scores Range 0 (no) - 1 (yes)\] Note: Ranges applicable only if question 4 was answered yes.
Time frame: Pre-treatment, one month post-treatment, and 6 months post-treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | Sexual Function | Pre-Treatment | 19.57 score on a scale | Standard Deviation 6.29 |
| Mindfulness-based Cognitive Therapy (MBCT) | Sexual Function | One Month Post-Treatment | 21.79 score on a scale | Standard Deviation 6.83 |
| Mindfulness-based Cognitive Therapy (MBCT) | Sexual Function | 6 months follow up | 24.75 score on a scale | Standard Deviation 5.62 |
| Cognitive Behavioural Therapy (CBT) | Sexual Function | Pre-Treatment | 21.18 score on a scale | Standard Deviation 6.1 |
| Cognitive Behavioural Therapy (CBT) | Sexual Function | One Month Post-Treatment | 23.41 score on a scale | Standard Deviation 5.72 |
| Cognitive Behavioural Therapy (CBT) | Sexual Function | 6 months follow up | 23.20 score on a scale | Standard Deviation 5.45 |