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

Low Female Sexual Desire Clinical Trial

— DESIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690897
• Other study ID #: H12-01659
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: March 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Female Sexual Desire

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Department of Gynaecology	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression	Depression will be measured with the Hamilton Depression Scale - Short Form (McIntyre et al., 2005)	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.
Other	Mindfulness	Mindfulness will be measured with the Five Factor Mindfulness questionnaire (Baer, Smith, Hopkins, Krietemeyer & Tony, 2006).	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.
Other	Relationship satisfaction	Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988).	Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment.
Other	Motivations for sex	Motivations for sex will be measured with the Motivations for Sex Measure (Muise et al., 2013); disruptions to the sexual response cycle (each cycle is one sexual encounter, specifically the most recent sexual encounter), which will be measured using the Sexual Response Cycle Worksheet (Basson, 2000).	For Motivations for Sex Measure: Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment. Time frame for sexual response cycle worksheet: measured at weeks 2, 5, and 8 of treatment.
Other	Perceived stress	Perceived stress will be measured with the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983).	Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment.
Other	Rumination	Rumination will be measured with the Rumination-Reflection Questionnaire - Adapted Rumination Subscale (adapted from Trapnell & Campbell, 1999 to inquire about sexuality-related rumination).	Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment.
Other	Trait anxiety and situational anxiety	At the sexual arousal assessments, which will be measured with the State-Trait Anxiety Inventory (Spielberger, Gorsuch, & Lushene, 1970).	Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment.
Other	Anxiety sensitivity	Anxiety sensitivity will be measured with the Anxiety Sensitivity Index - 3 (Taylor et al., 2007).	Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment.
Other	Self-compassion	Self-compassion will be measured with the Self-Compassion Scale (Neff, 2003).	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.
Other	Non-attachment	Non-attachment will be measures with Non-Attachment Scale (Sahdra, Shaver, & Brown, 2010).	Up to 2.5 months before treatment, 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment.
Other	Expectations of change with treatment	Will be measured with the Expectations Measure [a two-item questionnaire completed following the session 1, designed for and used in our approved mindfulness-based treatment study for provoked vestibulodynia (H12-02358)], and participants' impressions of change with treatment with the Patient Global Impression of Change Scale - Revised (adapted from Hurst & Bolton, 2004; as used in H12-02358).	Expectations Measure: after session 1. For Patient Global Impression of Change Scale: 2-4 weeks post treatment, 6 months post treatment, and 12 months post treatment.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.