Randomized Comparison of Mindfulness Versus Group Support for Treatment of Low Sexual Desire in Women

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an 8-session mindfulness-based intervention (MBCT group) is effective for women with low sexual interest/desire in reducing sexual distress, improving their sexual response, and increasing their mindful skills, compared to a support group.

Detailed Description
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HYPOTHESES: 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. 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. 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. We hypothesize that participation in the MBCT group will significantly increase concordance between genital and subjective sexual arousal. 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. Expectations of change with treatment will not significantly moderate improvements in sexual distress and desire in the MBCT group. Participants' impressions of change will be significantly greater in the MBCT group compared to the support group at all post-treatment assessment points. We hypothesize that participants will experience fewer breaks in the sexual response cycle throughout the course of the eight-week treatment.

Official Title
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Randomized Comparison of Mindfulness Versus Group Support for Treatment of Low Sexual Desire in Women

Conditions
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Low Female Sexual Desire

Intervention / Treatment
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* Behavioral: Mindfulness-based treatment
* Behavioral: Sex therapy, education, and support treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must be experiencing distressing sexual interest/desire and/or sexual arousal concerns must between the ages of 19 - 65 must be fluent in English Exclusion Criteria: not experiencing distressing sexual interest/desire and/or sexual arousal concerns not between the ages of 19-65 unable to read, write, speak and understand English

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT group<br>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. | Behavioral: Mindfulness-based treatment<br>* 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.<br>|
| Active Comparator: Support group<br>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. | Behavioral: Sex therapy, education, and support treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual distress | Sexual distress will be measured with the revised version of the Female Sexual Distress Scale-R (Derogatis et al., 2008). | up to 12 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sexual arousal | Subjects will indicate their levels of subjective arousal while undergoing arousal testing. A device manufactured for the UBC Sexual Health Lab called the arousometer- a computer mouse mounted on a metal track divided into 10 equally spaced intervals corresponding to sexually turned off (-2) to the most sexually aroused you have ever been or could imagine being (7). This device allows continuous self-report measurement of subjective sexual arousal while viewing the erotic films. | Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment. | 
| Interoceptive awareness | Interoceptive awareness will be measured using the Heartbeat Perception task (Schandry, 1981) and with the Multidimensional Assessment of Interoceptive Awareness (MAIA; Mehling et al., 2012) questionnaire. | Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment. | 
| Physiological sexual arousal | Physiological sexual arousal will be measured with a Vaginal Photoplethysmograph (VPP) during exposure to erotic films. The VPP measures vaginal pulse amplitude (VPA) which has been found to be a sensitive and specific measure of genital arousal (Laan & Everaerd, 1995). | Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment. | 
| Sexual desire | The Sexual Interest and Desire Inventory (SIDI; Clayton et al. 2006) will be used to measure sexual desire. | Up to 2.5 months before treatment, mid-treatment (between week 4 and 5 of treatment), 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment. | 
| Stress hormone ratios | Stress hormone ratios will be measured through calculating the cortisol:DHEA slope within participants' saliva samples. This will be done by measuring the change in cortisol:DHEA secretions over the course of the day, and calculating a simple difference score (PM minus AM values). | Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female sexual desire, Psychoeducational intervention, Mindfulness