What side effects are associated with this type of intervention?

The most common treatments for Persistent Genital Arousal Disorder (PGAD) using psychological and behavioral modification therapies such as Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behavior Therapy (DBT) are generally well-tolerated. However, they can cause emotional discomfort during sessions, increased anxiety or distress when confronting difficult topics, and a temporary exacerbation of symptoms. Group therapy formats may also cause discomfort for individuals uncomfortable with sharing personal experiences in a group setting.

What other types of research exist?

Promising novel alternatives to the Virtual Synchronous Cognitive Behavioural Therapy Group Program for PGAD patients include: 1) Pharmacological treatments such as selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, which have shown efficacy in related conditions. 2) Neuromodulation techniques like transcranial magnetic stimulation (TMS) or transcutaneous electrical nerve stimulation (TENS), which are being explored for various neurological and psychological disorders. 3) Mindfulness-based therapies and Acceptance and Commitment Therapy (ACT) delivered through digital platforms, which offer flexibility and accessibility. 4) Emerging research into the use of cannabinoids or other novel pharmacological agents targeting specific neural pathways involved in arousal and pain.

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Behavioral Intervention

Group Cognitive Behavioural Therapy for Persistent Genital Arousal Disorder

Q: What prior FDA approvals exist?

There are no specific FDA-approved treatments for Persistent Genital Arousal Disorder (PGAD). However, psychological and behavioral modification therapies such as Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behavior Therapy (DBT) are being studied for their effectiveness in managing PGAD symptoms. These therapies focus on education, skill-building, and mental health support, which can help alleviate the distress associated with PGAD.

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

No Placebo-Only Group

Summary

This trial tests an online group therapy program for women with PGAD/GPD. The program aims to teach coping skills and provide support through structured discussions. Participants will learn ways to manage their symptoms and improve their mental health.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after the end of the program for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Symptom distress

Symptom intensity

Secondary study objectives

Resilience

Symptom catastrophizing

Symptom self-efficacy

Other study objectives

Alliance

Anxiety

Depression

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Persistent Genital Arousal Disorder (PGAD) include Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behavior Therapy (DBT). CBT works by helping patients identify and change negative thought patterns and behaviors that contribute to their symptoms. ACT focuses on accepting distressing thoughts and feelings while committing to behavior changes that align with personal values. DBT combines cognitive-behavioral techniques with mindfulness practices to help patients manage emotional distress and improve interpersonal effectiveness. These therapies are crucial for PGAD patients as they address the psychological and behavioral aspects of the disorder, providing strategies to manage symptoms, reduce distress, and improve overall quality of life.

Exposure therapy in the treatment of vaginal penetration phobia: a single-case evaluation.Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder, With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study.Treatment of compulsive cybersex behavior.