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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01690897

Acronym

DESIRE

Enrollment

149

Registered

2012-09-24

Start date

2015-01-01

Completion date

2020-03-01

Last updated

2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Female Sexual Desire

Keywords

Female sexual desire, Psychoeducational intervention, Mindfulness

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.

Interventions

BEHAVIORALMindfulness-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.

BEHAVIORALSex 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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.

Secondary

Measure	Time frame	Description
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.
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.
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.

Other

Measure	Time frame	Description
Depression	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	Depression is measured with the Hamilton Depression Scale - Short Form (McIntyre et al., 2005). Seven questions on a scale of 0 - 4 with higher score meaning higher depression. Totals are summed with a possible range of scores from 0 - 28.
Perceived Stress	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	Perceived stress will be measured with the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983). Questions are likert scale from 0 - 4. Possible range of scores 0 - 40 with higher score indicating higher stress.
Mindfulness	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	Mindfulness will be measured with the Five Factor Mindfulness questionnaire (Baer, Smith, Hopkins, Krietemeyer & Tony, 2006). Questions are answered on a 5-point Likert scale ranging from 1 to 5. Possible range of scores 39 to 195 with higher score meaning higher mindfulness.

Countries

Canada

Participant flow

Participants by arm

Arm	Count
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. 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.	70
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. 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.	78
Total	148

Baseline characteristics

Characteristic	MBCT Group	Support Group	Total
Age, Continuous	39.3 years STANDARD_DEVIATION 13.2	37.9 years STANDARD_DEVIATION 12.2	38.6 years STANDARD_DEVIATION 12.6
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants	71 Participants	138 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants	6 Participants	9 Participants
Female Sexual Distress Scale-Revised (FSDS-R)	32.97 units on a scale STANDARD_DEVIATION 11.27	32.22 units on a scale STANDARD_DEVIATION 7.99	32.58 units on a scale STANDARD_DEVIATION 9.68
Region of Enrollment Canada	70 participants	78 participants	148 participants
Relationship Assessment Scale (RAS)	3.87 units on a scale STANDARD_DEVIATION 0.8	4.14 units on a scale STANDARD_DEVIATION 0.74	4.01 units on a scale STANDARD_DEVIATION 0.77
Rumination-Reflection Questionnaire (RRQ)	3.08 units on a scale STANDARD_DEVIATION 0.96	3.00 units on a scale STANDARD_DEVIATION 0.79	3.04 units on a scale STANDARD_DEVIATION 0.87
Sex: Female, Male Female	70 Participants	78 Participants	148 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants
Sexual Interest/Desire Inventory (SIDI)	16.99 units on a scale STANDARD_DEVIATION 8.16	15.41 units on a scale STANDARD_DEVIATION 6.66	16.17 units on a scale STANDARD_DEVIATION 7.43

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 70	0 / 78
other Total, other adverse events	0 / 70	0 / 78
serious Total, serious adverse events	0 / 70	0 / 78

Outcome results

Primary

Female Sexual Distress Scale-Revised (FSDS-R)

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.

Time frame: 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.