Clinical trial NCT01690897: Randomized Comparison of Mindfulness Versus Group Support for Treatment of Low Sexual Desire in Women
Official title: Randomized Comparison of Mindfulness Versus Group Support for Treatment of Low Sexual Desire in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Female Sexual Desire
Keywords: Female sexual desire
Psychoeducational intervention
Mindfulness
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 149
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Female Sexual Distress Scale-Revised (FSDS-R)
timeFrame: 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.
measure: Sexual Interest and Desire Inventory (SIDI)
timeFrame: 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.
measure: Rumination
timeFrame: 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.
measure: Relationship Assessment Scale (RAS)
timeFrame: 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.
Secondary outcomes:
measure: Subjective Sexual Arousal
timeFrame: 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
measure: Interoceptive Awareness
timeFrame: 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
measure: Physiological Sexual Arousal
timeFrame: 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
measure: Stress Hormone Cortisol Slope
timeFrame: 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
Other outcomes:
measure: Depression
timeFrame: 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
measure: Mindfulness
timeFrame: 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
measure: Perceived Stress
timeFrame: 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
Locations:
city: Vancouver
country: Canada
facility: Department of Gynaecology
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lori A Brotto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.