An interventional study of Mindfulness-based Cognitive Therapy and Cognitive Behavioural Therapy in Provoked Vestibulodynia, sponsored by University of British Columbia. Completed at 2 sites in Canada. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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:
106 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's enrollment of 130 is above the median of 44 across 79 interventional studies indexed under Vulvodynia.
Browse Vulvodynia studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Mindfulness-based Cognitive Therapy
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.
Behavioral: Cognitive Behavioural 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.
Also known as: MBCT
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.
Also known as: CBT
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.
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.
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.
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.
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..
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.
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.
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.
| Milestone | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) |
|---|---|---|
| Started | 67 | 63 |
| Completed | 59 | 49 |
| Not completed | 8 | 14 |
| Withdrew: Lost to follow-up | 8 | 14 |
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).
| score on a scale | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) |
|---|---|---|
| pre-treatment | 6.66 ± 2.17 | 6.62 ± 2.19 |
| one month post-treatment | 3.21 ± 1.96 | 3.60 ± 2.14 |
| 6 months follow up | 2.92 ± 2.31 | 2.86 ± 1.89 |
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).
| score on a scale | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) |
|---|---|---|
| Pre-treatment | 6.69 ± 1.91 | 5.86 ± 2.13 |
| One Month Post-Treatment | 4.34 ± 2.22 | 4.65 ± 2.21 |
| 6 months follow up | 3.39 ± 1.89 | 4.03 ± 2.11 |
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".
| score on a scale | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) |
|---|---|---|
| Pre-Treatment | 19.57 ± 6.29 | 21.18 ± 6.10 |
| One Month Post-Treatment | 21.79 ± 6.83 | 23.41 ± 5.72 |
| 6 months follow up | 24.75 ± 5.62 | 23.20 ± 5.45 |
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.
| score on a scale | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) |
|---|---|---|
| Pre-Treatment | 34.28 ± 11.18 | 35.68 ± 10.43 |
| One Month Post-Treatment | 26.60 ± 13.35 | 24.93 ± 91.31 |
| 6 months follow up | 22.81 ± 12.98 | 23.77 ± 9.61 |
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 \[Overall Range: 0 - 52\]
| score on a scale | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) |
|---|---|---|
| Pre-Treatment | 26.92 ± 12.86 | 25.62 ± 11.97 |
| One Month Post-Treatment | 15.64 ± 12.54 | 12.57 ± 8.13 |
| 6 months follow up | 11.55 ± 9.91 | 10.83 ± 7.66 |
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 \[Scores Range: 0 - 80\].
| score on a scale | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) |
|---|---|---|
| Pre-Treatment | 43.24 ± 14.67 | 42.46 ± 12.12 |
| One Month Post-Treatment | 39.74 ± 13.72 | 40.32 ± 14.19 |
| 6 months follow up | 38.50 ± 13.88 | 38.76 ± 14.47 |
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 \[Scores Range: 0 - 54\]
| score on a scale | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) |
|---|---|---|
| Pre-Treatment | 42.40 ± 10.91 | 42.39 ± 10.14 |
| One Month Post-Treatment | 47.97 ± 10.26 | 46.63 ± 9.34 |
| 6 months follow up | 49.24 ± 9.29 | 47.83 ± 8.70 |
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 \[Scores Range: 0 - 54\]
| score on a scale | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) |
|---|---|---|
| Pre-Treatment | 23.99 ± 9.29 | 22.91 ± 8.05 |
| One Month Post-Treatment | 29.34 ± 10.07 | 29.20 ± 8.42 |
| 6 months follow up | 33.72 ± 8.80 | 31.29 ± 8.51 |
Collected over The entire duration of the study up to 6 months post treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | — | — | — |
| Cognitive Behavioural Therapy (CBT) | — | — | — |
Participants comprised a total of 130 women diagnosed with PVD by a physician.
| Age, Continuous(years) | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) | Total |
|---|---|---|---|
| Mean | 33.72 ± 7.48 | 31.24 ± 8.99 | 32.35 ± 8.21 |
| Sex: Female, Male(Participants) | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) | Total |
|---|---|---|---|
| Female | 67 | 63 | 130 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) | Total |
|---|---|---|---|
| Euro-Canadian | 46 | 38 | 84 |
| South/East Asian | 10 | 11 | 21 |
| Other | 9 | 12 | 21 |
| Prefer Not To Answer | 2 | 2 | 4 |
| Relationship status(Participants) | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) | Total |
|---|---|---|---|
| Married / Common Law | 45 | 41 | 86 |
| Dating | 11 | 13 | 24 |
| Single | 11 | 8 | 19 |
| Did Not Disclose | 0 | 1 | 1 |
| Length of relationship(years) | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) | Total |
|---|---|---|---|
| Mean | 7.77 ± 6.16 | 7.56 ± 6.79 | 7.67 ± 7.52 |
| Satisfaction with relationship closeness (/10)(units on a scale) | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) | Total |
|---|---|---|---|
| Mean | 7.26 ± 2.29 | 7.79 ± 1.99 | 7.52 ± 2.15 |
| Education(participants) | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) | Total |
|---|---|---|---|
| High School | 1 | 2 | 3 |
| Some College | 10 | 17 | 27 |
| University Degree | 31 | 24 | 55 |
| Post-Graduate | 17 | 13 | 30 |
| Prefer Not To Answer | 8 | 7 | 15 |
| Level of typical pain (/10)(units on a scale) | Mindfulness-based Cognitive Therapy (MBCT) | Cognitive Behavioural Therapy (CBT) | Total |
|---|---|---|---|
| Mean | 6.04 ± 1.82 | 5.96 ± 2.11 | 6.00 ± 1.96 |
5 further baseline measures are reported on the registry.
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University of British Columbia