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Behavioral Intervention
Group Cognitive Behavioural Therapy for Persistent Genital Arousal Disorder
N/A
Recruiting
Led By Caroline Pukall, PhD
Research Sponsored by Dr. Caroline Pukall
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 6 months after the end of the program
Awards & highlights
Study Summary
This trial seeks to study the effectiveness of a group therapy program for women with PGAD/GPD, which includes elements of CBT, ACT, and DBT. Participants will provide survey responses before, during, and after treatment.
Who is the study for?
This trial is for women in Ontario, Canada who have been diagnosed with Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia. Participants must be over 18, fluent in English, and comfortable discussing their health and sexuality online. Those not fluent in English or uncomfortable with group therapy discussions are excluded.Check my eligibility
What is being tested?
The study tests an 8-week virtual group program using Cognitive Behavioural Therapy techniques to manage symptoms of PGAD/GPD. It includes education, skill-building, and discussion sessions aimed at improving mental health and sexual wellness.See study design
What are the potential side effects?
Since the intervention involves therapy without medication, typical medical side effects are not expected. However, participants may experience emotional discomfort or distress when discussing sensitive topics related to their condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after the end of the program
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after the end of the program
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Symptom distress
Symptom intensity
Secondary outcome measures
Resilience
Symptom catastrophizing
Symptom self-efficacy
Other outcome measures
Alliance
Anxiety
Depression
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cognitive behavioural therapyExperimental Treatment1 Intervention
The group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive behavioural therapy
2009
Completed Phase 4
~750
Find a Location
Who is running the clinical trial?
Dr. Caroline PukallLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Queen's UniversityLead Sponsor
366 Previous Clinical Trials
121,712 Total Patients Enrolled
Caroline Pukall, PhDPrincipal InvestigatorQueen's University
3 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been diagnosed with PGAD/GPD by a doctor.I am not comfortable discussing my health and PGAD/GPD symptoms in group video sessions.I am comfortable talking about my mental, physical health, and PGAD/GPD symptoms in online group sessions with video.I am under 18 years old.I am not fluent in English.I do not have health conditions that prevent me from participating in group therapy.I am 18 years old or older.I have been diagnosed with PGAD/GPD by a doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive behavioural therapy
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.
Are there any slots still available to join this research project?
"Affirmative. Clinicaltrials.gov portrays the trial as still actively recruiting; it was initially posted on April 24th 2023 and most recently updated June 23rd 2023, requesting 25 participants from a single site."
Answered by AI
What is the aggregate figure for those joining this clinical trial?
"Correct. According to clinicaltrials.gov, the trial initiated on April 24th 2023 and is currently enrolling patients. 25 participants are being sought for a single site."
Answered by AI
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