Low Female Sexual DesireDESIRENCT01690897
Randomized Comparison of Mindfulness Versus Group Support for Treatment of Low Sexual Desire in Women
A study testing Mindfulness-based treatment and Sex therapy, education, and support treatment in people with Low Female Sexual Desire, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Low Female Sexual Desire
- What is being tested?
- Mindfulness-based treatment and Sex therapy, education, and support treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2015to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must be experiencing distressing sexual interest/desire and/or sexual arousal concerns
- must between the ages of 19 - 65
- must be fluent in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
HYPOTHESES:
- 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.
- 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.
- 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.
- We hypothesize that participation in the MBCT group will significantly increase concordance between genital and subjective sexual arousal.
- 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.
- Expectations of change with treatment will not significantly moderate improvements in sexual distress and desire in the MBCT group.
- Participants' impressions of change will be significantly greater in the MBCT group compared to the support group at all post-treatment assessment points.
- We hypothesize that participants will experience fewer breaks in the sexual response cycle throughout the course of the eight-week treatment.
- Conditions
- Low Female Sexual Desire
- Being tested
- Mindfulness-based treatment, Sex therapy, education, and support treatment
- Keywords
- Female sexual desire, Psychoeducational intervention, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based treatmentBehavioural
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 treatmentBehavioural
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 group | Role | What they receive |
|---|---|---|
| MBCT group | Experimental | 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. Receives: Behavioral: Mindfulness-based treatment |
| Support group | Active comparator | 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. Receives: Behavioral: Sex therapy, education, and support treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 Interest and Desire Inventory (SIDI)
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.
Measured: 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
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.
Measured: 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 Assessment Scale (RAS)
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.
Measured: 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 (4)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Stress Hormone Cortisol Slope
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Female Sexual DesireStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
- Investigators
- Lori A Brotto, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690897
- Sponsor's protocol ID
- H12-01659
- Acronym
- DESIRE
- Status last verified
- Nov 2024
- First submitted
- 22 Aug 2012
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Brotto LA, Basson R, Grabovac A, Chivers ML, Zdaniuk B, Bodnar TS, Weinberg J. Impact of mindfulness versus supportive sex education on stress in women with sexual interest/arousal disorder. J Behav Med. 2024 Aug;47(4):721-733. doi: 10.1007/s10865-024-00491-5. Epub 2024 Apr 26.
PubMed 38668816Brotto 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.
PubMed 34383535
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Mindfulness Versus Group Support for Treatment of Low Sexual Desire in Women
- ClinicalTrials.gov ID
- NCT01690897
- Acronym / sponsor ID
- DESIRE / H12-01659
- Conditions
- Low Female Sexual Desire
- Keywords
- Female sexual desire, Psychoeducational intervention, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- We hypothesize that participation in the MBCT group will significantly increase concordance between genital and subjective sexual arousal.
- 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.
- Expectations of change with treatment will not significantly moderate improvements in sexual distress and desire in the MBCT group.
- Participants' impressions of change will be significantly greater in the MBCT group compared to the support group at all post-treatment assessment points.
- We hypothesize that participants will experience fewer breaks in the sexual response cycle throughout the course of the eight-week treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCT group | Experimental | Behavioral: Mindfulness-based treatmentWomen 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. |
| Support group | Active comparator | Behavioral: Sex therapy, education, and support treatmentWomen 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- must be experiencing distressing sexual interest/desire and/or sexual arousal concerns
- must between the ages of 19 - 65
- must be fluent in English
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based treatmentThe 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. | Behavioural | MBCT group |
| Sex therapy, education, and support treatmentThe 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. | Behavioural | Support group |
Primary outcome
Female Sexual Distress Scale-Revised (FSDS-R)
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.
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)
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.
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
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.
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)
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.
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.
4 secondary outcomes
Subjective Sexual Arousal
Time frame: 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
Time frame: 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
Time frame: 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
Stress Hormone Cortisol Slope
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38668816Brotto LA, Basson R, Grabovac A, Chivers ML, Zdaniuk B, Bodnar TS, Weinberg J. Impact of mindfulness versus supportive sex education on stress in women with sexual interest/arousal disorder. J Behav Med. 2024 Aug;47(4):721-733. doi: 10.1007/s10865-024-00491-5. Epub 2024 Apr 26.
- Derived from this study: PubMed 34383535Brotto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A Brotto, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based treatment and Sex therapy, education, and support treatment in people with Low Female Sexual Desire, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Distress Scale-Revised (FSDS-R) (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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690897, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.