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Cognitive-Behavioural Therapy - Online (CBT-O) for Female Sexual Dysfunction
N/A
Waitlist Available
Led By Lori Brotto, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Awards & highlights
Study Summary
This trial will test whether online cognitive-behavioral therapy or mindfulness-based therapy can help women with sexual dysfunction, who may have negative physical, psychological, and interpersonal outcomes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-treatment (within 2 weeks of completing the 8-module program)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment (within 2 weeks of completing the 8-module program)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in sexual desire
Change in sexual distress
Secondary outcome measures
Change in relational sexual concern
Change in relationship satisfaction
Change in satisfaction with life
+12 moreOther outcome measures
Big-Five personality traits (exploratory moderator)
Change in PTSD symptoms (exploratory outcome)
Change in depression (mediator)
+12 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: MBT-OExperimental Treatment1 Intervention
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.
Group II: CBT-OExperimental Treatment1 Intervention
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.
Group III: Wait-List ControlActive Control1 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.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,887 Total Patients Enrolled
Lori Brotto, PhDPrincipal InvestigatorThe University of British Columbia
3 Previous Clinical Trials
240 Total Patients Enrolled
Kyle Stephenson, PhDPrincipal InvestigatorXavier University of Louisiana.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your sexual dysfunction is caused by another mental health condition, substance use, a medical condition, or relationship conflicts that are not the focus of this study.You cannot receive any other treatment for your sexual difficulties while participating in the study.You regularly take strong pain medications prescribed by a doctor or use illegal drugs (except cannabis).You are planning to change any medications that might affect your sexual function during the study.You are planning to break up with your romantic partner within the next 6 months.Women, regardless of sexual orientation, are eligible to participate.You have had sex with a partner in the last 4 weeks and are willing to have sex with your partner during the study. This is needed to measure sexual function.Women, including transgender women, of any sexual orientation.You have a condition that affects your ability to feel sexually interested or aroused, as determined through a phone screening.You need to meet specific criteria during a phone screening to be diagnosed with sexual interest/arousal disorder.The participant must be in a stable and committed romantic relationship for at least six months in order to participate in the interventionYou must have the ability to take part in an 8-12 week treatment program online.You have anxiety or mood disorders that significantly interfere with your daily life and have not been well managed.You have trouble seeing well enough to read things on the internet.The participant must have consistent access to the internet and be competent in using online platforms.
Research Study Groups:
This trial has the following groups:- Group 1: CBT-O
- Group 2: MBT-O
- Group 3: Wait-List Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on enrolment for this clinical trial?
"Affirmative. The clinicaltrials.gov website confirms that, as of January 14th 2022, this medical trial is still recruiting participants - with 129 patients being sought at a single site since it's initial posting on November 12th 2021."
Answered by AI
What is the purpose of this research endeavor?
"This clinical trial, which includes evaluation at baseline; mid-treatment (around 5 weeks after the commencement of an 8 module program); post-treatment (immediately after finishing the same 8 module course); and 6 months follow up seeks to assess Change in sexual desire. The secondary objectives include Treatment satisfaction for modules 1, 2 & 3. This is evaluated through a single item measure asking participants to rate helpfulness of content covered each week as well as ease of reading it on 0 to 10 scale where research suggests that score higher than 6.5/10 denotes acceptable utility and clarity regarding said content."
Answered by AI
Are there any vacancies still available for participants in this trial?
"As per the latest information hosted on clinicaltrials.gov, this trial is actively recruiting suitable candidates for participation. The study was first announced on November 12th 2021 and its most recent update was posted on January 14th 2022."
Answered by AI
Who else is applying?
What state do they live in?
British Columbia
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
UBC Sexual Health Research Lab; Gordon & Leslie Diamond Health Care Centre
Why did patients apply to this trial?
This has been an ongoing issue for years now and I'm with the one I want to be with and I have zero desire and the prescriptions are more than I can afford and no benefits cover the new drug.
PatientReceived no prior treatments
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