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

Not Applicable

Completed

• Conditions: Low Female Sexual Desire
• Interventions: Behavioral: Sex therapy, education, and support treatment; Behavioral: Mindfulness-based treatment

• Registration Number: NCT01690897
• Lead Sponsor: University of British Columbia

Brief Summary

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

HYPOTHESES:

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.

Study Timeline

• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-24
• Study Start: 2015-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-01
• Results First Submitted: 2022-11-01
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Results First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Support group	Sex therapy, education, and support treatment	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.
MBCT group	Mindfulness-based treatment	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.

Primary Outcome Measures

Name	Time	Method
Female Sexual Distress Scale-Revised (FSDS-R)	2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.	Sexual distress will be measured with the revised version of the Female Sexual Distress Scale-R (Derogatis et al., 2008). Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress.
Sexual Interest and Desire Inventory (SIDI)	2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.	The Sexual Interest and Desire Inventory (SIDI; Clayton et al. 2006) will be used to measure sexual desire. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning.
Rumination	2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.	Rumination was measured with the Rumination-Reflection Questionnaire - Adapted Rumination Subscale (adapted from Trapnell \& Campbell, 1999 to inquire about sexuality-related rumination). Likert scale 1 - 5 with higher score indicating higher rumination.
Relationship Assessment Scale (RAS)	2-4 weeks post treatment (10-12 weeks after start of treatment), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start of treatment). Assessments completed past 1 year were due to personal delays by co-investigator.	Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988). Scoring: Add each item score and divide by 7 to get a mean score. Higher score relates to higher satisfaction. Minimum mean score 1, maximum score 5.

Secondary Outcome Measures

Name	Time	Method
Subjective Sexual Arousal	Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-I	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.
Interoceptive Awareness	Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-I	Interoceptive awareness will be measured using the Multidimensional Assessment of Interoceptive Awareness (MAIA; Mehling et al., 2012) questionnaire. Possible range of scores 0 - 5. Higher score means higher awareness.
Physiological Sexual Arousal	Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-I	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). There is no threashold on the millivolts (MV) reading.
Stress Hormone Cortisol Slope	Up to 2 mos pre-treatment, 2-4 weeks post treatment (10-12 weeks after treatment start), 6 months post (approx 8 months after start), and 12 months post (approx 14 months after start). Assessments completed past 1 year were due to personal delays by Co-I	The diurnal cortisol slope is the difference in cortisol levels from morning to evening (PM minus AM). To assay salivary cortisol concentrations, samples were vortexed and centrifuged at 1,400 g for 10 minutes at 18°C. Salivary cortisol was measured using the commercially available High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit (Salimetrics Assays, 1-3002, State College, PA) according to the standard protocol. The minimum amount of saliva required by this assay is 25 μl, and intra- and inter-assay coefficients of variation were 4.6% and 6.0%, respectively.

Trial Locations

Locations (1)

Department of Gynaecology; 🇨🇦 Vancouver, British Columbia, Canada