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

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.

Study Overview

• Status: Completed
• Conditions: Low Female Sexual Desire
• Intervention / Treatment: Behavioral: Mindfulness-based treatment; Behavioral: Sex therapy, education, and support treatment

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 Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Department of Gynaecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
ACTIVE_COMPARATOR: 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.	Behavioral: 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of British Columbia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: September 21, 2012
• First Posted (ESTIMATE): September 24, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Mindfulness; Psychoeducational intervention; Female sexual desire
• Other Study ID Numbers: H12-01659