CompletedNot Applicable

Cognitive-Behavioural & Mindfulness-Based Online Programs for Female Sexual Dysfunction

Canada129 participantsStarted 2021-11-12

Plain-language 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 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 pl…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in sexual distress

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT05168371

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

View on ClinicalTrials.gov More Female Sexual Dysfunction trials

Plain-language summary

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in sexual distress

Timeframe: 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

Timeframe: 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