COMFORT: Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia

• Sponsor: University of British Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01704456
• Collaborator: (none)
• Enrollment: 130
• Locations: 2
• Arms: 2
• Duration (Months): 59
• Patients Per Site: 65
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Provoked Vestibulodynia	Behavioral: Mindfulness-based Cognitive Therapy; Behavioral: Cognitive Behavioural Therapy	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.; Other Names: MBCT
Experimental: 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.	Behavioral: 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.; Other Names: CBT

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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".

3. 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.

4. 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]

5. 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].

6. 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]

7. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	British Columbia Centre for Sexual Medicine	Vancouver	British Columbia	Canada	V5Z 1M9
2	Department of Gynaecology	Vancouver	British Columbia	Canada	V5Z 1M9

Sponsors and Collaborators

• University of British Columbia

Investigators

• Principal Investigator: Lori A Brotto, PhD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• UBC Sexual Health Lab
• Published Paper

Publications

None provided.

• Responsible Party: Lori Brotto, Associate Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT01704456
• Other Study ID Numbers: H12-02358
• First Posted: Oct 11, 2012
• Last Update Posted: Mar 10, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Lori Brotto, Associate Professor, University of British Columbia: provoked vestibulodynia; dyspareunia; vulvodynia; mindfulness; cognitive behavioural therapy
• Additional relevant MeSH terms: Vulvodynia; Vulvar Vestibulitis

Study Results

Participant Flow

Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)	Cognitive Behavioural Therapy (CBT)
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	67	63
COMPLETED	59	49
NOT COMPLETED	8	14

Baseline Characteristics

Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)	Cognitive Behavioural Therapy (CBT)	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	67	63	130
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.72 (7.48)	31.24 (8.99)	32.35 (8.21)
Sex: Female, Male (Count of Participants)
Female	67 100%	63 100%	130 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Euro-Canadian	46 68.7%	38 60.3%	84 64.6%
South/East Asian	10 14.9%	11 17.5%	21 16.2%
Other	9 13.4%	12 19%	21 16.2%
Prefer Not To Answer	2 3%	2 3.2%	4 3.1%
Relationship status (Count of Participants)
Married / Common Law	45 67.2%	41 65.1%	86 66.2%
Dating	11 16.4%	13 20.6%	24 18.5%
Single	11 16.4%	8 12.7%	19 14.6%
Did Not Disclose	0 0%	1 1.6%	1 0.8%
Length of relationship (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.77 (6.16)	7.56 (6.79)	7.67 (7.52)
Satisfaction with relationship closeness (/10) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.26 (2.29)	7.79 (1.99)	7.52 (2.15)
Education (participants) [Number]
High School	1 1.5%	2 3.2%	3 2.3%
Some College	10 14.9%	17 27%	27 20.8%
University Degree	31 46.3%	24 38.1%	55 42.3%
Post-Graduate	17 25.4%	13 20.6%	30 23.1%
Prefer Not To Answer	8 11.9%	7 11.1%	15 11.5%
Level of typical pain (/10) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.04 (1.82)	5.96 (2.11)	6.00 (1.96)
Level of worst pain (/10) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.23 (1.10)	8.23 (1.32)	8.23 (1.21)
Years since diagnosis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.85 (7.72)	6.02 (4.72)	7.95 (6.67)
PVD history (Count of Participants)
Lifelong	43 64.2%	37 58.7%	80 61.5%
Aquired	24 35.8%	26 41.3%	50 38.5%
Past treatments received (participants) [Number]
Number [participants]	36 53.7%	29 46%	65 50%
Past medications received (participants) [Number]
Number [participants]	8 11.9%	11 17.5%	19 14.6%

Outcome Measures

1. Primary Outcome

Title	Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)	Cognitive Behavioural Therapy (CBT)
Arm/Group Description	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.	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.
Measure Participants	67	63
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)

2. Secondary Outcome

Title	Self-reported Pain During Penetration
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)	Cognitive Behavioural Therapy (CBT)
Arm/Group Description	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.	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.
Measure Participants	67	63
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)

3. Secondary Outcome

Title	Sexual Function
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)	Cognitive Behavioural Therapy (CBT)
Arm/Group Description	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.	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.
Measure Participants	67	63
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)

4. Secondary Outcome

Title	Sexual Distress
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)	Cognitive Behavioural Therapy (CBT)
Arm/Group Description	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.	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.
Measure Participants	67	63
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)

5. Secondary Outcome

Title	Pain Catastrophizing
Description	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..

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)	Cognitive Behavioural Therapy (CBT)
Arm/Group Description	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.	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.
Measure Participants	67	63
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)

6. Secondary Outcome

Title	Pain Hypervigilance
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)	Cognitive Behavioural Therapy (CBT)
Arm/Group Description	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.	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.
Measure Participants	67	63
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)

7. Secondary Outcome

Title	Chronic Pain Acceptance, Activities Engagement
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)	Cognitive Behavioural Therapy (CBT)
Arm/Group Description	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.	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.
Measure Participants	67	63
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)

8. Secondary Outcome

Title	Chronic Pain Acceptance, CPAQ Pain Willingness
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)	Cognitive Behavioural Therapy (CBT)
Arm/Group Description	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.	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.
Measure Participants	67	63
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)

Adverse Events

Time Frame	The entire duration of the study up to 6 months post treatment.
Adverse Event Reporting Description	Adverse event data was not collected; only reason for withdrawal. We interpreted risk as being due to a medication and this was a behavioral trial. We did not exclude participants with symptoms of anxiety or depression, and it is possible that those symptoms may have put participants at risk.
Arm/Group Title	Mindfulness-based Cognitive Therapy (MBCT)		Cognitive Behavioural Therapy (CBT)
Arm/Group Description	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.		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.
All Cause Mortality
	Mindfulness-based Cognitive Therapy (MBCT)		Cognitive Behavioural Therapy (CBT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Mindfulness-based Cognitive Therapy (MBCT)		Cognitive Behavioural Therapy (CBT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Mindfulness-based Cognitive Therapy (MBCT)		Cognitive Behavioural Therapy (CBT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.