Randomized Comparison of Mindfulness Versus Group Support for Treatment of Low Sexual Desire in Women
NCT ID: NCT01690897
Last Updated: 2024-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
149 participants
INTERVENTIONAL
2015-01-01
2020-03-01
Brief Summary
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Detailed Description
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1. Compared to baseline, the MBCT group will have significant post-treatment improvements in self-report measures of: (a) sexual distress; (b) sexual desire, subjective sexual arousal, perception of genital arousal, and sexual pleasure; (c) relationship satisfaction; (d) depressive symptoms and rumination; (e) perceived stress, general anxiety, anxiety sensitivity, and sexuality-related situational anxiety (as self-reported at the sexual arousal assessment); and (f) mindfulness, self-compassion, non-attachment, and interoceptive awareness.
2. Compared to baseline, the MBCT group will have significant post-treatment improvements in laboratory physiological measures of: (a) genital sexual response as measured by a vaginal photoplethysmograph, (b) interoceptive awareness, as measured by a heart rate perception task, and (c) cortisol:DHEA ratio as measured by hormonal assays of saliva samples.
3. We hypothesize that the changes in the endpoints listed in #1 or #2 will be significantly greater in the MBCT group than in the support group.
4. We hypothesize that participation in the MBCT group will significantly increase concordance between genital and subjective sexual arousal.
5. Mindfulness, self-compassion, and interoceptive awareness will significantly mediate improvements in sexual distress and desire in the MBCT group at all post-treatment assessment points.
6. Expectations of change with treatment will not significantly moderate improvements in sexual distress and desire in the MBCT group.
7. Participants' impressions of change will be significantly greater in the MBCT group compared to the support group at all post-treatment assessment points.
8. We hypothesize that participants will experience fewer breaks in the sexual response cycle throughout the course of the eight-week treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MBCT group
Women randomized into the MBCT group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the mindfulness-based treatment.
Mindfulness-based treatment
The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
Support group
Women randomized into the support group will undergo pre-treatment testing (questionnaires, saliva sample collection, and physiological assessment) within 2.5 months of beginning the sex therapy, education, and support treatment.
Sex therapy, education, and support treatment
The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
Interventions
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Mindfulness-based treatment
The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
Sex therapy, education, and support treatment
The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
Eligibility Criteria
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Inclusion Criteria
* must between the ages of 19 - 65
* must be fluent in English
Exclusion Criteria
* not between the ages of 19-65
* unable to read, write, speak and understand English
19 Years
65 Years
FEMALE
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Lori Brotto
Professor, UBC Department of Gynaecology
Principal Investigators
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Lori A Brotto, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Department of Gynaecology
Vancouver, British Columbia, Canada
Countries
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References
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Brotto LA, Basson R, Grabovac A, Chivers ML, Zdaniuk B, Bodnar TS, Weinberg J. Impact of mindfulness versus supportive sex education on stress in women with sexual interest/arousal disorder. J Behav Med. 2024 Aug;47(4):721-733. doi: 10.1007/s10865-024-00491-5. Epub 2024 Apr 26.
Brotto LA, Zdaniuk B, Chivers ML, Jabs F, Grabovac A, Lalumiere ML, Weinberg J, Schonert-Reichl KA, Basson R. A randomized trial comparing group mindfulness-based cognitive therapy with group supportive sex education and therapy for the treatment of female sexual interest/arousal disorder. J Consult Clin Psychol. 2021 Jul;89(7):626-639. doi: 10.1037/ccp0000661.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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H12-01659
Identifier Type: -
Identifier Source: org_study_id