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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
No Placebo-Only Group
Summary
This trial tests two online therapy programs for women with sexual dysfunction. These therapies help women manage their thoughts and feelings to improve their sexual health. The goal is to make effective treatments more accessible and affordable.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in sexual desire
Change in sexual distress
Secondary study objectives
Change in relational sexual concern
Change in relationship satisfaction
Change in satisfaction with life
+12 moreOther study objectives
Big-Five personality traits (exploratory moderator)
Change in PTSD symptoms (exploratory outcome)
Change in depression (mediator)
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
1,466 Previous Clinical Trials
2,485,327 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.
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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.
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