Female Sexual DysfunctionNCT05168371
Cognitive-Behavioural & Mindfulness-Based Online Programs for Female Sexual Dysfunction
A study testing Cognitive-Behavioural Therapy - Online (CBT-O) and Mindfulness-Based Therapy - Online (MBT-O) in people with Female Sexual Dysfunction, run by University of British Columbia at 1 site in Canada.
Trial summary
Female sexual dysfunction (FSD) affects approximately one-third of women worldwide and is linked to negative physical, psychological, and interpersonal outcomes. Although both cognitive-behavioral therapy and mindfulness-based therapy are effective treatments for FSD, face-to-face treatments can be costly and are… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Cognitive-Behavioural Therapy - Online (CBT-O) and Mindfulness-Based Therapy - Online (MBT-O)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteCanada
- Study dates
- 12 Nov 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cis and trans women of any sexual orientation.
- Must be fluent in English (online materials delivered in English).
- Must have consistent access to the internet, basic competency in using online platforms (self-report).
- Must be in a committed, stable romantic relationship of at least 6 months (because aspects of the interventions require partner participation). Partners may be of any gender.
- Must meet telephone screening diagnostic criteria for sexual interest/arousal disorder.
- Must be sexually active with a partner over the preceding 4 weeks (due to the sexual function outcome measure), and willing to engage in sexual activity with their partner during the study.
- Must be able to participate in an 8-12-week online treatment.
Who cannot join
- Have sexual dysfunction that is, in their estimation, fully attributable to another psychiatric diagnosis, the effect of a substance, a general medical condition (e.g., Multiple Sclerosis), or non-sexual conflict in the relationship, none of which are meant to be addressed by the proposed interventions.
- Poorly managed Anxiety or Mood Disorder (as per degree of life interference assessed at screening).
- Report visual impairments that would make it difficult to read online materials.
- Are regularly using prescription narcotics illegal recreational drug (not including cannabis).
- Plan to change their medications known to impact sexual function over the course of the study.
- On assessment report plans to end their romantic relationship in the next 6 months.
- Engage in any other treatment for their sexual difficulties during the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
UBC Sexual Health Research Lab; Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Pilot RCT for Cognitive-Behavioural & Mindfulness-Based Online Programs for Female Sexual Dysfunction
Female sexual dysfunction (FSD) affects approximately one-third of women worldwide and is linked to negative physical, psychological, and interpersonal outcomes. Although both cognitive-behavioral therapy and mindfulness-based therapy are effective treatments for FSD, face-to-face treatments can be costly and are inaccessible to many people in remote areas. The goal of the current study is to pilot a randomized controlled trial to examine the effectiveness of and satisfaction with two online interventions for FSD. Women will be randomized to an online cognitive-behavioral program, an online mindfulness-based program, or a wait-list control group. Treatment will be administered entirely online and last 8-12 weeks. Women will meet weekly via Zoom with a navigator who will provide individualized support.
Read the detailed description
HYPOTHESES:
- Compared to women in the wait-list control arm, women in the CBT and MBT arms will have significant post-treatment and follow-up improvements in self-report measures of the primary outcomes: (a) sexual distress and (b) sexual desire.
- Compared to women in the wait-list control arm, women in the CBT and MBT arms will have significant post-treatment and follow-up improvements in self-report measures of the secondary outcomes: (a) overall sexual function, (b) sexual satisfaction, (c) relational sexual concern, (d) satisfaction with life, and (e) relationship satisfaction.
- Improvements in depression, sexual avoidance, and sexual consequences will significantly mediate improvements in primary outcomes at all post-treatment assessment points.
- Higher levels of baseline relationship satisfaction, higher levels of partner involvement, more positive baseline expectations about treatment efficacy, higher levels of treatment compliance, and perceiving higher levels of empathy and effectiveness from navigators will predict greater improvements in primary outcomes at post-treatment and follow-up.
- Baseline personality will moderate intervention effects at post-treatment and follow-up.
- Women in both the CBT and MBT arms will report being satisfied with treatment.
- Conditions
- Female Sexual Dysfunction
- Being tested
- Cognitive-Behavioural Therapy - Online (CBT-O), Mindfulness-Based Therapy - Online (MBT-O)
- Keywords
- Sexual Desire, Mindfulness, Cognitive Behavioral Therapy, Cognitive Behavioural Therapy, Mindfulness Based Therapy, Digital Health, Sexual Interest/Arousal Disorder, Female Sexual Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioural Therapy - Online (CBT-O)Behavioural
Face-to-face CBT was adapted for web-based self-directed therapy. CBT-O was found to be feasible and usable (Stephenson et al., 2021; Zippan et al., 2020).
Each of the eight modules has between-module activities to complete. The eight modules are: 1) Psychoeducation, introduction to CBT; 2) The cognitive model and thought records; 3) Unhelpful thinking patterns; 4) Cognitive restructuring; 5) Behavioral experiments; 6) Self-touch and sensate focus; 7) Sensate focus with your partner; and 8) Maintaining (and extending) your gains.
Mindfulness-Based Therapy - Online (MBT-O)Behavioural
The content of MBT-O was adapted from an efficacious face-to-face mindfulness intervention for women with Sexual Interest/Arousal Disorder (Brotto et al., 2021; Paterson et al., 2017). MBT-O was found to be feasible and usable (Brotto et al., under review).
Each of the eight modules has between-module activities to complete. The eight modules are: 1) Psychoeducation, introduction to mindfulness; 2) Increasing awareness of physical sensations in the body; 3) Exploring movement and body image; 4) Awareness of sexual thoughts and beliefs; 5) Working with aversion, self-touch; 6) Exploring sexual sensations, knowing limits; 7) Integrating the partner into mindful touching; and 8) Maintaining (and extending) your gains.
| Study group | Role | What they receive |
|---|---|---|
| CBT-O | Experimental | Women randomized to this arm will receive access to the eight modules of Cognitive-Behavioural Therapy-Online (CBT-O). Participants will meet weekly via Zoom with treatment navigators during the 8-12 weeks that it takes to complete the program. Receives: Behavioral: Cognitive-Behavioural Therapy - Online (CBT-O) |
| MBT-O | Experimental | Women randomized to this arm will receive access to the eight modules of Mindfulness-Based Therapy-Online (MBT-O). Participants will meet weekly via Zoom with treatment navigators during the 8-12 weeks that it takes to complete the program. Receives: Behavioral: Mindfulness-Based Therapy - Online (MBT-O) |
| Wait-List Control | No intervention | Participants who are randomized to the wait-list group will complete two baseline online questionnaire/assessment batteries before being randomized to one of the active treatment groups. Participants will be randomized into one of the active treatment groups after a 10 week waiting period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sexual distress
Revised version of the Female Sexual Distress Scale-R (Derogatis et al., 2008). Scores on the scale range from 0-52, where higher scores represent higher levels of distress.
Measured: baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Change in sexual desire
The Sexual Interest and Desire Inventory (SIDI; Clayton et al. 2006) total score will be used to measure sexual desire. Possible total scores range from 0-51, with higher scores indicating higher levels of sexual functioning.
Measured: baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Secondary outcomes (15)
Change in sexual function
Female Sexual Function Index total score (FSFI; Rosen et al., 2000). Scores range from 2 - 36 where increase in sexual dysfunction is represented by lower scores.
Measured: baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Change in sexual satisfaction
Quality of Sex Inventory (QSI; Shaw \& Rogge, 2016). For all items, responses are given values on a 0 to 5 point scale with 0 = Not at all TRUE and 5 = Completely TRUE. The items of the sexual satisfaction subscale are summed to create a total where higher scores indicate higher levels of sexual satisfaction (0-60). The items of the sexual dissatisfaction subscale are summed separately to create a total where higher scores reflect higher levels of sexual dissatisfaction (0-60).
Measured: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Change in relational sexual concern
Relational concern subscale of the Sexual Satisfaction Scale-Women (SSS-W; Meston \& Trapnell, 2005). Scores range from 6-30, with higher scores reflecting lower levels of sexual relational concern.
Measured: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Change in relationship satisfaction
Couples satisfaction index (CSI-16; Funk \& Rogge, 2007). CSI-16 scores can range from 0 to 81. Higher scores indicate higher levels of relationship satisfaction.
Measured: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Treatment satisfaction for module 1
Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 1.
Measured: An average of 1 week after starting the 8-module program
Treatment satisfaction for module 2
Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 2.
Measured: An average of 2 weeks after starting the 8-module program
Treatment satisfaction for module 3
Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 3.
Measured: An average of 3 weeks after starting the 8-module program
Treatment satisfaction for module 4
Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 4.
Measured: An average of 5 weeks after starting the 8-module program
Treatment satisfaction for module 5
Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 5.
Measured: An average of 6 weeks after starting the 8-module program
Treatment satisfaction for module 6
Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 6.
Measured: An average of 7 weeks after starting the 8-module program
Treatment satisfaction for module 7
Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 7.
Measured: An average of 9 weeks after starting the 8-module program
Treatment satisfaction for module 8
Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 8.
Measured: An average of 10 weeks after starting the 8-module program
Quantitative program treatment satisfaction as assessed by the adapted Erectile Dysfunction Inventory of Treatment Satisfaction
Adapted Erectile Dysfunction Inventory of Treatment Satisfaction (Althof et al., 1999; items 1-10). Scores range from 0-40, with higher scores reflecting higher treatment satisfaction.
Measured: post-treatment (within 2 weeks of completing the 8-module program)
Qualitative program treatment satisfaction
Qualitative feedback about eSense and between-module activities collected by treatment navigators.
Measured: through completion of the 8-module program, an average of 10 weeks
Change in satisfaction with life
Satisfaction with Life Scale (Diener et al., 1985). Scores range from 5-35, with higher scores reflecting higher levels of life satisfaction.
Measured: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start12 Nov 2021
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Sexual DysfunctionStudies 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
- 129 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 Brotto, PhD, Principal investigator, The University of British ColumbiaKyle Stephenson, PhD, Principal investigator, Xavier University of Louisiana.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168371
- Sponsor's protocol ID
- H20-03914
- Status last verified
- Mar 2025
- First submitted
- 23 Nov 2021
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brotto LA, Stephenson KR, Marshall N, Balvan M, Okara Y, Mahar EA. Evaluating a Digital Health Tool Designed to Improve Low Sexual Desire in Women: Mixed-Methods Implementation Science Study. J Med Internet Res. 2025 Mar 25;27:e69828. doi: 10.2196/69828.
PubMed 40132194
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT for Cognitive-Behavioural & Mindfulness-Based Online Programs for Female Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT05168371
- Acronym / sponsor ID
- H20-03914
- Conditions
- Female Sexual Dysfunction
- Keywords
- Sexual Desire, Mindfulness, Cognitive Behavioral Therapy, Cognitive Behavioural Therapy, Mindfulness Based Therapy, Digital Health, Sexual Interest/Arousal Disorder, Female Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Female sexual dysfunction (FSD) affects approximately one-third of women worldwide and is linked to negative physical, psychological, and interpersonal outcomes. Although both cognitive-behavioral therapy and mindfulness-based therapy are effective treatments for FSD, face-to-face treatments can be costly and are inaccessible to many people in remote areas. The goal of the current study is to pilot a randomized controlled trial to examine the effectiveness of and satisfaction with two online interventions for FSD. Women will be randomized to an online cognitive-behavioral program, an online mindfulness-based program, or a wait-list control group. Treatment will be administered entirely online and last 8-12 weeks. Women will meet weekly via Zoom with a navigator who will provide individualized support.
Detailed description
HYPOTHESES:
- Compared to women in the wait-list control arm, women in the CBT and MBT arms will have significant post-treatment and follow-up improvements in self-report measures of the primary outcomes: (a) sexual distress and (b) sexual desire.
- Compared to women in the wait-list control arm, women in the CBT and MBT arms will have significant post-treatment and follow-up improvements in self-report measures of the secondary outcomes: (a) overall sexual function, (b) sexual satisfaction, (c) relational sexual concern, (d) satisfaction with life, and (e) relationship satisfaction.
- Improvements in depression, sexual avoidance, and sexual consequences will significantly mediate improvements in primary outcomes at all post-treatment assessment points.
- Higher levels of baseline relationship satisfaction, higher levels of partner involvement, more positive baseline expectations about treatment efficacy, higher levels of treatment compliance, and perceiving higher levels of empathy and effectiveness from navigators will predict greater improvements in primary outcomes at post-treatment and follow-up.
- Baseline personality will moderate intervention effects at post-treatment and follow-up.
- Women in both the CBT and MBT arms will report being satisfied with treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-O | Experimental | Behavioral: Cognitive-Behavioural Therapy - Online (CBT-O)Women randomized to this arm will receive access to the eight modules of Cognitive-Behavioural Therapy-Online (CBT-O). Participants will meet weekly via Zoom with treatment navigators during the 8-12 weeks that it takes to complete the program. |
| MBT-O | Experimental | Behavioral: Mindfulness-Based Therapy - Online (MBT-O)Women randomized to this arm will receive access to the eight modules of Mindfulness-Based Therapy-Online (MBT-O). Participants will meet weekly via Zoom with treatment navigators during the 8-12 weeks that it takes to complete the program. |
| Wait-List Control | No intervention | –Participants who are randomized to the wait-list group will complete two baseline online questionnaire/assessment batteries before being randomized to one of the active treatment groups. Participants will be randomized into one of the active treatment groups after a 10 week waiting period. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cis and trans women of any sexual orientation.
- Must be fluent in English (online materials delivered in English).
- Must have consistent access to the internet, basic competency in using online platforms (self-report).
- Must be in a committed, stable romantic relationship of at least 6 months (because aspects of the interventions require partner participation). Partners may be of any gender.
- Must meet telephone screening diagnostic criteria for sexual interest/arousal disorder.
Key exclusion criteria (7 listed)
- Have sexual dysfunction that is, in their estimation, fully attributable to another psychiatric diagnosis, the effect of a substance, a general medical condition (e.g., Multiple Sclerosis), or non-sexual conflict in the relationship, none of which are meant to be addressed by the proposed interventions.
- Poorly managed Anxiety or Mood Disorder (as per degree of life interference assessed at screening).
- Report visual impairments that would make it difficult to read online materials.
- Are regularly using prescription narcotics illegal recreational drug (not including cannabis).
- Plan to change their medications known to impact sexual function over the course of the study.
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 |
|---|---|---|
| Cognitive-Behavioural Therapy - Online (CBT-O)Face-to-face CBT was adapted for web-based self-directed therapy. CBT-O was found to be feasible and usable (Stephenson et al., 2021; Zippan et al., 2020). Each of the eight modules has between-module activities to complete. The eight modules are: 1) Psychoeducation, introduction to CBT; 2) The cognitive model and thought records; 3) Unhelpful thinking patterns; 4) Cognitive restructuring; 5) Behavioral experiments; 6) Self-touch and sensate focus; 7) Sensate focus with your partner; and 8) Maintaining (and extending) your gains. | Behavioural | CBT-O |
| Mindfulness-Based Therapy - Online (MBT-O)The content of MBT-O was adapted from an efficacious face-to-face mindfulness intervention for women with Sexual Interest/Arousal Disorder (Brotto et al., 2021; Paterson et al., 2017). MBT-O was found to be feasible and usable (Brotto et al., under review). Each of the eight modules has between-module activities to complete. The eight modules are: 1) Psychoeducation, introduction to mindfulness; 2) Increasing awareness of physical sensations in the body; 3) Exploring movement and body image; 4) Awareness of sexual thoughts and beliefs; 5) Working with aversion, self-touch; 6) Exploring sexual sensations, knowing limits; 7) Integrating the partner into mindful touching; and 8) Maintaining (and extending) your gains. | Behavioural | MBT-O |
Primary outcome
Change in sexual distress
Time frame: baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Revised version of the Female Sexual Distress Scale-R (Derogatis et al., 2008). Scores on the scale range from 0-52, where higher scores represent higher levels of distress.
Change in sexual desire
Time frame: baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
The Sexual Interest and Desire Inventory (SIDI; Clayton et al. 2006) total score will be used to measure sexual desire. Possible total scores range from 0-51, with higher scores indicating higher levels of sexual functioning.
15 secondary outcomes
Change in sexual function
Time frame: baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Change in sexual satisfaction
Time frame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Change in relational sexual concern
Time frame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Change in relationship satisfaction
Time frame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Treatment satisfaction for module 1
Time frame: An average of 1 week after starting the 8-module program
Treatment satisfaction for module 2
Time frame: An average of 2 weeks after starting the 8-module program
Treatment satisfaction for module 3
Time frame: An average of 3 weeks after starting the 8-module program
Treatment satisfaction for module 4
Time frame: An average of 5 weeks after starting the 8-module program
Treatment satisfaction for module 5
Time frame: An average of 6 weeks after starting the 8-module program
Treatment satisfaction for module 6
Time frame: An average of 7 weeks after starting the 8-module program
Treatment satisfaction for module 7
Time frame: An average of 9 weeks after starting the 8-module program
Treatment satisfaction for module 8
Time frame: An average of 10 weeks after starting the 8-module program
Quantitative program treatment satisfaction as assessed by the adapted Erectile Dysfunction Inventory of Treatment Satisfaction
Time frame: post-treatment (within 2 weeks of completing the 8-module program)
Qualitative program treatment satisfaction
Time frame: through completion of the 8-module program, an average of 10 weeks
Change in satisfaction with life
Time frame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 40132194Brotto LA, Stephenson KR, Marshall N, Balvan M, Okara Y, Mahar EA. Evaluating a Digital Health Tool Designed to Improve Low Sexual Desire in Women: Mixed-Methods Implementation Science Study. J Med Internet Res. 2025 Mar 25;27:e69828. doi: 10.2196/69828.
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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 Brotto, PhD principal investigator
The University of British Columbia
Kyle Stephenson, PhD principal investigator
Xavier University of Louisiana.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioural Therapy - Online (CBT-O) and Mindfulness-Based Therapy - Online (MBT-O) in people with Female Sexual Dysfunction, 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 7 inclusion and 7 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 26 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in sexual distress (time frame: baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up). The study lists 2 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 NCT05168371, which also lists 1 linked publication.
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 26 Mar 2025.