Cognitive-Behavioural & Mindfulness-Based Online Programs for Female

Status Active, not recruiting

Clinical 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 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.

Clinical Trial Description

HYPOTHESES: 1. 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. 2. 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. 3. Improvements in depression, sexual avoidance, and sexual consequences will significantly mediate improvements in primary outcomes at all post-treatment assessment points. 4. 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. 5. Baseline personality will moderate intervention effects at post-treatment and follow-up. 6. Women in both the CBT and MBT arms will report being satisfied with treatment. ;

Study Design

Related Conditions & MeSH terms

Female Sexual Dysfunction

Clinical Trial Details

NCT number	NCT05168371
Study type	Interventional
Source	University of British Columbia
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 12, 2021
Completion date	November 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05806424` - Investigation of Awareness Levels of Women Living in Turkey About Kegel Exercises and Pelvic Floor Muscles
Completed	`NCT01364623` - PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women	Phase 1
Completed	`NCT06060691` - the Ameliorating Effects of Antioxidant Gel on Female Arousal Disorder and Sexual Dysfunction	Phase 1
Recruiting	`NCT04419961` - Sexual Dysfunction and an Educational Program to Improve the Quality of Sexual Function in Vietnamese Pregnant Women in First Trimester	N/A
Completed	`NCT04122703` - Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction	N/A
Recruiting	`NCT03498443` - Effect of Pelvic Organ Prolapse Surgeries on Female Sexual Function in Egyptian Women
Completed	`NCT03232801` - A Mindfulness-based Intervention for Older Women With Low Sexual Desire	N/A
Completed	`NCT04124640` - Observational Study in Real Life to Describe the Libicare® Effectiveness in Female Sexual Dysfunction.
Completed	`NCT00995072` - Comparative Effects of Nebivolol and Metoprolol on Female Sexual Function	N/A
Completed	`NCT04384172` - Effect of Peripheral Neuromodulation on Vaginal Blood Flow	N/A
Recruiting	`NCT06237166` - Evaluation of an Online Intervention for Female Sexual Dysfunction	N/A
Completed	`NCT03463707` - BP101 for Adults With Female Sexual Dysfunction	Phase 3
Recruiting	`NCT01078077` - The Impact of a Topical Vasodilating Cream on Female Sexual Experience	N/A
Completed	`NCT01724658` - Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women	Phase 2
Completed	`NCT02229721` - Effect of Chronic Intranasal Oxytocin Administration on Sexual Function in Pre- and Postmenopausal Women	Phase 2
Completed	`NCT00479570` - Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.	Phase 2
Not yet recruiting	`NCT06116045` - Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women With Sexual Arousal Disorder	Phase 2
Withdrawn	`NCT02862184` - Female Sexual Dysfunction, Risks and Outcomes (FSFI)	N/A
Completed	`NCT01195701` - Clitoral Location in Relation to Sexual Function Using Pelvic Imaging	N/A
Completed	`NCT04484753` - Validation of iPelvis App for Female Pelvic Floor Dysfunction	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms