Trial Outcomes & Findings for Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia (NCT NCT01704456)
NCT ID: NCT01704456
Last Updated: 2020-03-10
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
Pre-treatment, one month post-treatment and 6 months post-treatment.
Results posted on
2020-03-10
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
63
|
|
Overall Study
COMPLETED
|
59
|
49
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
14
|
Baseline Characteristics
Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia
Baseline characteristics by cohort
| Measure |
Mindfulness-based Cognitive Therapy (MBCT)
n=67 Participants
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.
|
Cognitive Behavioural Therapy (CBT)
n=63 Participants
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
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.72 years
STANDARD_DEVIATION 7.48 • n=5 Participants
|
31.24 years
STANDARD_DEVIATION 8.99 • n=7 Participants
|
32.35 years
STANDARD_DEVIATION 8.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Euro-Canadian
|
46 participants
n=5 Participants
|
38 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South/East Asian
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Prefer Not To Answer
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Relationship status
Married / Common Law
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Relationship status
Dating
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Relationship status
Single
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Relationship status
Did Not Disclose
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Length of relationship
|
7.77 years
STANDARD_DEVIATION 6.16 • n=5 Participants
|
7.56 years
STANDARD_DEVIATION 6.79 • n=7 Participants
|
7.67 years
STANDARD_DEVIATION 7.52 • n=5 Participants
|
|
Satisfaction with relationship closeness (/10)
|
7.26 units on a scale
STANDARD_DEVIATION 2.29 • n=5 Participants
|
7.79 units on a scale
STANDARD_DEVIATION 1.99 • n=7 Participants
|
7.52 units on a scale
STANDARD_DEVIATION 2.15 • n=5 Participants
|
|
Education
High School
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Education
Some College
|
10 participants
n=5 Participants
|
17 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Education
University Degree
|
31 participants
n=5 Participants
|
24 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Education
Post-Graduate
|
17 participants
n=5 Participants
|
13 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Education
Prefer Not To Answer
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Level of typical pain (/10)
|
6.04 units on a scale
STANDARD_DEVIATION 1.82 • n=5 Participants
|
5.96 units on a scale
STANDARD_DEVIATION 2.11 • n=7 Participants
|
6.00 units on a scale
STANDARD_DEVIATION 1.96 • n=5 Participants
|
|
Level of worst pain (/10)
|
8.23 units on a scale
STANDARD_DEVIATION 1.10 • n=5 Participants
|
8.23 units on a scale
STANDARD_DEVIATION 1.32 • n=7 Participants
|
8.23 units on a scale
STANDARD_DEVIATION 1.21 • n=5 Participants
|
|
Years since diagnosis
|
9.85 years
STANDARD_DEVIATION 7.72 • n=5 Participants
|
6.02 years
STANDARD_DEVIATION 4.72 • n=7 Participants
|
7.95 years
STANDARD_DEVIATION 6.67 • n=5 Participants
|
|
PVD history
Lifelong
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
PVD history
Aquired
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Past treatments received
|
36 participants
n=5 Participants
|
29 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Past medications received
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Mindfulness-based Cognitive Therapy (MBCT)
n=67 Participants
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.
|
Cognitive Behavioural Therapy (CBT)
n=63 Participants
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.
|
|---|---|---|
|
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
|
6.62 score on a scale
Standard Deviation 2.19
|
|
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
|
3.60 score on a scale
Standard Deviation 2.14
|
|
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
|
2.86 score on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Mindfulness-based Cognitive Therapy (MBCT)
n=67 Participants
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.
|
Cognitive Behavioural Therapy (CBT)
n=63 Participants
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.
|
|---|---|---|
|
Self-reported Pain During Penetration
Pre-treatment
|
6.69 score on a scale
Standard Deviation 1.91
|
5.86 score on a scale
Standard Deviation 2.13
|
|
Self-reported Pain During Penetration
One Month Post-Treatment
|
4.34 score on a scale
Standard Deviation 2.22
|
4.65 score on a scale
Standard Deviation 2.21
|
|
Self-reported Pain During Penetration
6 months follow up
|
3.39 score on a scale
Standard Deviation 1.89
|
4.03 score on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: 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".
Outcome measures
| Measure |
Mindfulness-based Cognitive Therapy (MBCT)
n=67 Participants
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.
|
Cognitive Behavioural Therapy (CBT)
n=63 Participants
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.
|
|---|---|---|
|
Sexual Function
Pre-Treatment
|
19.57 score on a scale
Standard Deviation 6.29
|
21.18 score on a scale
Standard Deviation 6.10
|
|
Sexual Function
One Month Post-Treatment
|
21.79 score on a scale
Standard Deviation 6.83
|
23.41 score on a scale
Standard Deviation 5.72
|
|
Sexual Function
6 months follow up
|
24.75 score on a scale
Standard Deviation 5.62
|
23.20 score on a scale
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mindfulness-based Cognitive Therapy (MBCT)
n=67 Participants
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.
|
Cognitive Behavioural Therapy (CBT)
n=63 Participants
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.
|
|---|---|---|
|
Sexual Distress
Pre-Treatment
|
34.28 score on a scale
Standard Deviation 11.18
|
35.68 score on a scale
Standard Deviation 10.43
|
|
Sexual Distress
One Month Post-Treatment
|
26.60 score on a scale
Standard Deviation 13.35
|
24.93 score on a scale
Standard Deviation 91.31
|
|
Sexual Distress
6 months follow up
|
22.81 score on a scale
Standard Deviation 12.98
|
23.77 score on a scale
Standard Deviation 9.61
|
SECONDARY outcome
Timeframe: 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 \[Overall Range: 0 - 52\]
Outcome measures
| Measure |
Mindfulness-based Cognitive Therapy (MBCT)
n=67 Participants
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.
|
Cognitive Behavioural Therapy (CBT)
n=63 Participants
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.
|
|---|---|---|
|
Pain Catastrophizing
Pre-Treatment
|
26.92 score on a scale
Standard Deviation 12.86
|
25.62 score on a scale
Standard Deviation 11.97
|
|
Pain Catastrophizing
One Month Post-Treatment
|
15.64 score on a scale
Standard Deviation 12.54
|
12.57 score on a scale
Standard Deviation 8.13
|
|
Pain Catastrophizing
6 months follow up
|
11.55 score on a scale
Standard Deviation 9.91
|
10.83 score on a scale
Standard Deviation 7.66
|
SECONDARY outcome
Timeframe: 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 \[Scores Range: 0 - 80\].
Outcome measures
| Measure |
Mindfulness-based Cognitive Therapy (MBCT)
n=67 Participants
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.
|
Cognitive Behavioural Therapy (CBT)
n=63 Participants
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.
|
|---|---|---|
|
Pain Hypervigilance
Pre-Treatment
|
43.24 score on a scale
Standard Deviation 14.67
|
42.46 score on a scale
Standard Deviation 12.12
|
|
Pain Hypervigilance
One Month Post-Treatment
|
39.74 score on a scale
Standard Deviation 13.72
|
40.32 score on a scale
Standard Deviation 14.19
|
|
Pain Hypervigilance
6 months follow up
|
38.50 score on a scale
Standard Deviation 13.88
|
38.76 score on a scale
Standard Deviation 14.47
|
SECONDARY outcome
Timeframe: 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 \[Scores Range: 0 - 54\]
Outcome measures
| Measure |
Mindfulness-based Cognitive Therapy (MBCT)
n=67 Participants
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.
|
Cognitive Behavioural Therapy (CBT)
n=63 Participants
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.
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|---|---|---|
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Chronic Pain Acceptance, Activities Engagement
Pre-Treatment
|
42.40 score on a scale
Standard Deviation 10.91
|
42.39 score on a scale
Standard Deviation 10.14
|
|
Chronic Pain Acceptance, Activities Engagement
One Month Post-Treatment
|
47.97 score on a scale
Standard Deviation 10.26
|
46.63 score on a scale
Standard Deviation 9.34
|
|
Chronic Pain Acceptance, Activities Engagement
6 months follow up
|
49.24 score on a scale
Standard Deviation 9.29
|
47.83 score on a scale
Standard Deviation 8.70
|
SECONDARY outcome
Timeframe: 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 \[Scores Range: 0 - 54\]
Outcome measures
| Measure |
Mindfulness-based Cognitive Therapy (MBCT)
n=67 Participants
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.
|
Cognitive Behavioural Therapy (CBT)
n=63 Participants
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.
|
|---|---|---|
|
Chronic Pain Acceptance, CPAQ Pain Willingness
Pre-Treatment
|
23.99 score on a scale
Standard Deviation 9.29
|
22.91 score on a scale
Standard Deviation 8.05
|
|
Chronic Pain Acceptance, CPAQ Pain Willingness
One Month Post-Treatment
|
29.34 score on a scale
Standard Deviation 10.07
|
29.20 score on a scale
Standard Deviation 8.42
|
|
Chronic Pain Acceptance, CPAQ Pain Willingness
6 months follow up
|
33.72 score on a scale
Standard Deviation 8.80
|
31.29 score on a scale
Standard Deviation 8.51
|
Adverse Events
Mindfulness-based Cognitive Therapy (MBCT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Behavioural Therapy (CBT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place