Integrated Mindfulness for Provoked Vestibulodynia (IMPROVED)
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| ClinicalTrials.gov Identifier: NCT01704443 |
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Recruitment Status :
Completed
First Posted : October 11, 2012
Last Update Posted : June 1, 2017
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Sponsor:
University of British Columbia
Information provided by (Responsible Party):
Lori Brotto, University of British Columbia
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Brief Summary:
This study aims to test the efficacy of a 4-session intervention (Group psychoeducational treatment) using a randomized study design. Participants will be randomized in to 'immediate treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session IMPROVED treatment, just as women randomized to the experimental group, after the end of their wait-list period.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Provoked Vestibulodynia | Behavioral: Group Psychoeducational Treatment Other: Waitlist control | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 97 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Integrated Mindfulness for Provoked Vestibulodynia |
| Study Start Date : | April 2008 |
| Actual Primary Completion Date : | November 2012 |
| Actual Study Completion Date : | April 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Immediate treatment
Women in the Immediate treatment arm will receive the Group Psychoeducational treatment in the next available group. There will be 8-9 womenper group and each session will be 2.25 hours in duration and there will be 4, bi-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.
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Behavioral: Group Psychoeducational Treatment
The Group Psychoeducational Treatment consists of treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be four, bi-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. Participants in the Waitlist Control Condition will receive this treatment at the end of the waitlist period (approximately 8 weeks) |
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Experimental: Waitlist Control- delayed treatment
Women in the Waitlist Control arm will receive no treatment for a period of approximately 8 weeks. After the waitlist period they will receive the same Group Psychoeducational treatment as the participants in the immediate treatment arm of the study.
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Other: Waitlist control
No treatment will be provided during the 8 week Waitlist control period |
Primary Outcome Measures :
- Pain intensity [ Time Frame: one week pre-treatment to one week post treatment ]Pain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch.
- Long-term pain intensity [ Time Frame: One week pre-treatment to 6 months post preatment ]Pain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch
Secondary Outcome Measures :
- Sexual Distress [ Time Frame: One week pre-treatment, one week post treatment and 6-months follow up ]The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised (Derogatis et al, 2008)
Other Outcome Measures:
- Pain Catastrophising [ Time Frame: one week pre-treatment, one week post treatment and 6-months follow-up ]The investigators will examine women's self-reported pain catastrophising by administering the Pain Catastrophizing Scale (Sullivan, Bishop & Pivik, 1995).
- Pain hypervigilance [ Time Frame: one week pre-treatment, one week post treatment and 6-months follow-up ]The investigators will examine women's self-report hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire, McCracken, 1997)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- must be a patient at the British Columbia Centre for Sexual Medicine
- diagnosis of provoked vestibulodynia (PVD)
- 19 years of age or older
- premenopausal
- fluent in English
Exclusion Criteria:
- not at patient at the BC Centre for Sexual Medicine
- unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain
- being uncomfortable and unwilling to participate in a group setting.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704443
Locations
| Canada, British Columbia | |
| British Columbia Centre for Sexual Medicine | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
Sponsors and Collaborators
University of British Columbia
Investigators
| Principal Investigator: | Lori A Brotto, PhD | University of British Columbia |
Additional Information:
| Responsible Party: | Lori Brotto, Principal Investigator, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01704443 History of Changes |
| Other Study ID Numbers: |
H08-00885 |
| First Posted: | October 11, 2012 Key Record Dates |
| Last Update Posted: | June 1, 2017 |
| Last Verified: | May 2017 |
Keywords provided by Lori Brotto, University of British Columbia:
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provoked vestibulodynia dyspareunia vulvodynia mindfulness cognitive behavioural therapy |
Additional relevant MeSH terms:
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Vulvodynia Vulvar Vestibulitis Vulvar Diseases Genital Diseases, Female Vulvitis |