Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT01704456
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2012-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004414', 'term': 'Dyspareunia'}, {'id': 'D056650', 'term': 'Vulvodynia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099025', 'term': 'Mindfulness-Based Cognitive Therapy'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lori.brotto@vch.ca', 'phone': '604-875-4111', 'title': 'Dr Lori Brotto', 'phoneExt': '68898', 'organization': 'UBC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The entire duration of the study up to 6 months post treatment.', '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.'}, {'id': 'OG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.'}], 'classes': [{'title': 'pre-treatment', 'categories': [{'measurements': [{'value': '6.66', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '6.62', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': 'one month post-treatment', 'categories': [{'measurements': [{'value': '3.21', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': '6 months follow up', 'categories': [{'measurements': [{'value': '2.92', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '2.86', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, one month post-treatment and 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).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported Pain During Penetration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.'}, {'id': 'OG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '6.69', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '5.86', 'spread': '2.13', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-Treatment', 'categories': [{'measurements': [{'value': '4.34', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '4.65', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': '6 months follow up', 'categories': [{'measurements': [{'value': '3.39', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '4.03', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment,one month post-treatment, and 6 months follow-up.', '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sexual Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.'}, {'id': 'OG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.'}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '19.57', 'spread': '6.29', 'groupId': 'OG000'}, {'value': '21.18', 'spread': '6.10', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-Treatment', 'categories': [{'measurements': [{'value': '21.79', 'spread': '6.83', 'groupId': 'OG000'}, {'value': '23.41', 'spread': '5.72', 'groupId': 'OG001'}]}]}, {'title': '6 months follow up', 'categories': [{'measurements': [{'value': '24.75', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '23.20', 'spread': '5.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post-treatment.', '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.\n\nSubscales:\n\nDesire- 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)\\]\n\nNote: Ranges applicable only if question 4 was answered "yes".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sexual Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.'}, {'id': 'OG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.'}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '34.28', 'spread': '11.18', 'groupId': 'OG000'}, {'value': '35.68', 'spread': '10.43', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-Treatment', 'categories': [{'measurements': [{'value': '26.60', 'spread': '13.35', 'groupId': 'OG000'}, {'value': '24.93', 'spread': '91.31', 'groupId': 'OG001'}]}]}, {'title': '6 months follow up', 'categories': [{'measurements': [{'value': '22.81', 'spread': '12.98', 'groupId': 'OG000'}, {'value': '23.77', 'spread': '9.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post-treatment.', '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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Catastrophizing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.'}, {'id': 'OG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.'}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '26.92', 'spread': '12.86', 'groupId': 'OG000'}, {'value': '25.62', 'spread': '11.97', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-Treatment', 'categories': [{'measurements': [{'value': '15.64', 'spread': '12.54', 'groupId': 'OG000'}, {'value': '12.57', 'spread': '8.13', 'groupId': 'OG001'}]}]}, {'title': '6 months follow up', 'categories': [{'measurements': [{'value': '11.55', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '10.83', 'spread': '7.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post-treatment..', '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.\n\nSubscales: 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\\]", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Hypervigilance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.'}, {'id': 'OG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.'}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '43.24', 'spread': '14.67', 'groupId': 'OG000'}, {'value': '42.46', 'spread': '12.12', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-Treatment', 'categories': [{'measurements': [{'value': '39.74', 'spread': '13.72', 'groupId': 'OG000'}, {'value': '40.32', 'spread': '14.19', 'groupId': 'OG001'}]}]}, {'title': '6 months follow up', 'categories': [{'measurements': [{'value': '38.50', 'spread': '13.88', 'groupId': 'OG000'}, {'value': '38.76', 'spread': '14.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post treatment.', '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\\].", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Chronic Pain Acceptance, Activities Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.'}, {'id': 'OG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.'}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '42.40', 'spread': '10.91', 'groupId': 'OG000'}, {'value': '42.39', 'spread': '10.14', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-Treatment', 'categories': [{'measurements': [{'value': '47.97', 'spread': '10.26', 'groupId': 'OG000'}, {'value': '46.63', 'spread': '9.34', 'groupId': 'OG001'}]}]}, {'title': '6 months follow up', 'categories': [{'measurements': [{'value': '49.24', 'spread': '9.29', 'groupId': 'OG000'}, {'value': '47.83', 'spread': '8.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post-treatment.', '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.\n\nSubscales:\n\nActivities 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\\]", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Chronic Pain Acceptance, CPAQ Pain Willingness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.'}, {'id': 'OG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.'}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '23.99', 'spread': '9.29', 'groupId': 'OG000'}, {'value': '22.91', 'spread': '8.05', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-Treatment', 'categories': [{'measurements': [{'value': '29.34', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '29.20', 'spread': '8.42', 'groupId': 'OG001'}]}]}, {'title': '6 months follow up', 'categories': [{'measurements': [{'value': '33.72', 'spread': '8.80', 'groupId': 'OG000'}, {'value': '31.29', 'spread': '8.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post treatment.', '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.\n\nSubscales:\n\nActivities 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\\]", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.'}, {'id': 'FG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness-based Cognitive Therapy (MBCT)', '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.\n\nMindfulness-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.'}, {'id': 'BG001', 'title': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.\n\nCognitive 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.72', 'spread': '7.48', 'groupId': 'BG000'}, {'value': '31.24', 'spread': '8.99', 'groupId': 'BG001'}, {'value': '32.35', 'spread': '8.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Euro-Canadian', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': 'South/East Asian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Prefer Not To Answer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Relationship status', 'classes': [{'categories': [{'title': 'Married / Common Law', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Dating', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Single', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Did Not Disclose', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Length of relationship', 'classes': [{'categories': [{'measurements': [{'value': '7.77', 'spread': '6.16', 'groupId': 'BG000'}, {'value': '7.56', 'spread': '6.79', 'groupId': 'BG001'}, {'value': '7.67', 'spread': '7.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Satisfaction with relationship closeness (/10)', 'classes': [{'categories': [{'measurements': [{'value': '7.26', 'spread': '2.29', 'groupId': 'BG000'}, {'value': '7.79', 'spread': '1.99', 'groupId': 'BG001'}, {'value': '7.52', 'spread': '2.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'How satisfied are you with the level of closeness in your relationship on a scale where 0=completely dissatisfied and 10=completely satisfied', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Education', 'classes': [{'title': 'High School', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Some College', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'University Degree', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Post-Graduate', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Prefer Not To Answer', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Level of typical pain (/10)', 'classes': [{'categories': [{'measurements': [{'value': '6.04', 'spread': '1.82', 'groupId': 'BG000'}, {'value': '5.96', 'spread': '2.11', 'groupId': 'BG001'}, {'value': '6.00', 'spread': '1.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Level of worst pain (/10)', 'classes': [{'categories': [{'measurements': [{'value': '8.23', 'spread': '1.10', 'groupId': 'BG000'}, {'value': '8.23', 'spread': '1.32', 'groupId': 'BG001'}, {'value': '8.23', 'spread': '1.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Years since diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '9.85', 'spread': '7.72', 'groupId': 'BG000'}, {'value': '6.02', 'spread': '4.72', 'groupId': 'BG001'}, {'value': '7.95', 'spread': '6.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PVD history', 'classes': [{'title': 'Lifelong', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'Aquired', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Lifelong vs Aquired PVD', 'unitOfMeasure': 'Participants'}, {'title': 'Past treatments received', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Past medications received', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants comprised a total of 130 women diagnosed with PVD by a physician.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2012-08-22', 'resultsFirstSubmitDate': '2019-10-09', 'studyFirstSubmitQcDate': '2012-10-09', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-25', 'studyFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment', 'timeFrame': 'Pre-treatment, one month post-treatment and 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)."}], 'secondaryOutcomes': [{'measure': 'Self-reported Pain During Penetration', 'timeFrame': 'Pre-treatment,one month post-treatment, and 6 months follow-up.', '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).'}, {'measure': 'Sexual Function', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post-treatment.', '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.\n\nSubscales:\n\nDesire- 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)\\]\n\nNote: Ranges applicable only if question 4 was answered "yes".'}, {'measure': 'Sexual Distress', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post-treatment.', '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."}, {'measure': 'Pain Catastrophizing', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post-treatment..', '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.\n\nSubscales: 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\\]"}, {'measure': 'Pain Hypervigilance', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post treatment.', '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\\]."}, {'measure': 'Chronic Pain Acceptance, Activities Engagement', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post-treatment.', '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.\n\nSubscales:\n\nActivities 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\\]"}, {'measure': 'Chronic Pain Acceptance, CPAQ Pain Willingness', 'timeFrame': 'Pre-treatment, one month post-treatment, and 6 months post treatment.', '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.\n\nSubscales:\n\nActivities 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\\]"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['provoked vestibulodynia', 'dyspareunia', 'vulvodynia', 'mindfulness', 'cognitive behavioural therapy'], 'conditions': ['Provoked Vestibulodynia']}, 'referencesModule': {'references': [{'pmid': '32843320', 'type': 'DERIVED', 'citation': 'Brotto LA, Zdaniuk B, Rietchel L, Basson R, Bergeron S. Moderators of Improvement From Mindfulness-Based vs Traditional Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia. J Sex Med. 2020 Nov;17(11):2247-2259. doi: 10.1016/j.jsxm.2020.07.080. Epub 2020 Aug 22.'}], 'seeAlsoLinks': [{'url': 'http://brottolab.med.ubc.ca', 'label': 'UBC Sexual Health Lab'}, {'url': 'https://med-fom-brotto.sites.olt.ubc.ca/files/2019/07/Brotto-et-al.-A-comparison-of-mindfulness2019.pdf', 'label': 'Published Paper'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'PURPOSE:\n\nThe 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.\n\nHYPOTHESES:\n\n1. 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.\n2. 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.\n3. 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.\n4. 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.\n5. 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of provoked vestibulodynia (PVD)\n* 19 years of age or older\n* premenopausal\n* fluent in English\n* during the study, women must agree not to change any medications they are taking for PVD.\n\nExclusion Criteria:\n\n* unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain\n* being uncomfortable and unwilling to participate in a group setting.'}, 'identificationModule': {'nctId': 'NCT01704456', 'acronym': 'COMFORT', 'briefTitle': 'Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia', 'orgStudyIdInfo': {'id': 'H12-02358'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-based cognitive therapy (MBCT)', '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.', 'interventionNames': ['Behavioral: Mindfulness-based Cognitive Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioural Therapy (CBT)', 'description': '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.', 'interventionNames': ['Behavioral: Cognitive Behavioural Therapy']}], 'interventions': [{'name': 'Mindfulness-based Cognitive Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['MBCT'], 'description': '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.', 'armGroupLabels': ['Mindfulness-based cognitive therapy (MBCT)']}, {'name': 'Cognitive Behavioural Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': '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.', 'armGroupLabels': ['Cognitive Behavioural Therapy (CBT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Centre for Sexual Medicine', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Department of Gynaecology', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Lori A Brotto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lori Brotto', 'investigatorAffiliation': 'University of British Columbia'}}}}