Group Cognitive Behavioural Therapy for Persistent Genital Arousal Disorder

Overseen By Caroline Pukall, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Caroline Pukall

Disqualifiers: Under 18, Nonfluent English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of virtual group therapy for women with Persistent Genital Arousal Disorder (PGAD), a condition causing unwanted and persistent genital arousal. The program incorporates various therapy techniques, such as Cognitive Behavioural Therapy (CBT), to help manage symptoms and enhance mental health and daily life. Participants will attend eight weekly sessions and complete online surveys about their symptoms and well-being. Women living in Ontario, Canada, who have been diagnosed with PGAD and feel comfortable discussing their health in group sessions might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve support for women with PGAD.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this group cognitive-behavioural treatment program is safe?

Research has shown that cognitive behavioral therapy (CBT) is generally safe and well-tolerated. Many individuals have tried CBT for various mental health issues and found it helpful. No serious risks are known with this type of therapy, and most participants report positive experiences.

This study uses a group format, which might offer additional support by allowing participants to share experiences with others. For any concerns, discussing them with the clinical team is advisable. They can provide more specific information related to individual situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment because it offers a novel approach to managing Persistent Genital Arousal Disorder (PGAD) through a group cognitive-behavioral therapy program. Unlike traditional treatments, which may include medications like antidepressants or topical anesthetics, this program integrates elements from Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT) in a virtual, group setting. This combination not only addresses the psychological aspects of PGAD but also provides a supportive community environment, potentially enhancing emotional well-being and coping strategies.

What evidence suggests that this group cognitive behavioural therapy is effective for PGAD/GPD?

Research shows that cognitive-behavioral therapy (CBT) effectively treats various mental health conditions by teaching skills to cope with and manage symptoms. Studies have found that CBT, often combined with Acceptance and Commitment Therapy (ACT) and Dialectical Behavior Therapy (DBT), reduces distress and improves mental health. Although specific data on Persistent Genital Arousal Disorder (PGAD) is limited, CBT is known to help with related mental health issues and enhance overall well-being. Some reports suggest that patients experience benefits such as reduced social and work-related stress and increased self-compassion. This trial will evaluate a group therapy program incorporating CBT, ACT, and DBT to determine its effectiveness in managing PGAD symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Caroline Pukall, PhD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am comfortable talking about my mental, physical health, and PGAD/GPD symptoms in online group sessions with video.

Fluent in English

Reside in Ontario, Canada

Exclusion 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.

Not comfortable with answering questions about mental, physical, sexual health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a virtual, synchronous cognitive behavioural therapy (CBT) group program for 8 weeks, focusing on education, understanding, and management of PGAD/GPD symptoms

8 weeks

8 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys conducted 3 and 6 months post-treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Group Cognitive-behavioural Treatment Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Cognitive behavioural therapy Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Dr. Caroline Pukall

Lead Sponsor

Trials

3

Recruited

130+

Dr. Caroline Pukall

Lead Sponsor

Trials

3

Recruited

130+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Published Research Related to This Trial

Persistent genital arousal disorder is a newly recognized and poorly understood condition, highlighting the need for more research to validate existing findings.

The article provides a comprehensive overview of current literature, offering guidance on the definition, potential causes, assessment, and management strategies for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent genital arousal disorder: a review of the literature and recommendations for management. Goldmeier, D., Mears, A., Hiller, J., et al.[2015]

A 58-year-old woman with persistent genital arousal disorder (PGAD) experienced significant improvements after undergoing an integrative therapy approach, which included cognitive behavior therapy and mindfulness practices, over 14 sessions.

The patient reported reduced distress and better coping with PGAD symptoms, as well as improvements in her overall quality of life, suggesting that psychological interventions may be effective for managing PGAD/GPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Treatment of Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia Using an Integrative Approach. Merwin, KE., Brotto, LA.[2023]

Persistent genital arousal disorder (PGAD) is a distressing condition that can significantly impact patients' lives, and it often requires a multidisciplinary approach for effective management.

Addressing co-occurring psychological and psychiatric issues is crucial in treating PGAD, as appropriate interventions can lead to improvements in both physical symptoms and psychological distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent Genital Arousal Disorder (PGAD): A Clinical Review and Case Series in Support of Multidisciplinary Management. Pease, ER., Ziegelmann, M., Vencill, JA., et al.[2022]

A 71-year-old woman with persistent genital arousal disorder (PGAD) showed significant improvements in anxiety, depression, sleep quality, and overall quality of life after receiving 9 sessions of hypnotherapy.

This case study suggests that hypnotherapy could be a promising treatment option for patients with PGAD, especially given the lack of established treatments for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypnotherapy for persistent genital arousal disorder: a case study. Elkins, GR., Ramsey, D., Yu, Y.[2018]

A study involving 36 pregnant women showed that cognitive-behavioral therapy (CBT) significantly improved sexual function and self-efficacy compared to routine healthcare training, with results measured two and four weeks after the intervention.

Before the intervention, there was no significant difference in sexual function between the groups, but after eight weeks of CBT, the improvements were statistically significant, indicating the effectiveness of CBT in enhancing sexual health during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive-behavioral therapy on sexual function and sexual self-efficacy in pregnant women: An RCT. Nezamnia, M., Iravani, M., Bargard, MS., et al.[2022]

A postmenopausal woman experienced persistent genital arousal disorder (PGAD) linked to a periclitoral mass that compressed the dorsal nerve of the clitoris, a previously unreported physical cause.

Surgical excision of the mass led to complete resolution of her symptoms, highlighting the importance of considering localized physical causes in the diagnosis and treatment of PGAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A periclitoral mass as a cause of persistent genital arousal disorder. Bedell, S., Goldstein, AT., Burrows, L.[2019]

A pilot study involving 17 female patients demonstrated the effectiveness of a multi-faceted inpatient program that uses behavior modification techniques to address severe sexual dysfunction.

The program's approach suggests that combining various therapeutic strategies can be beneficial in treating complex sexual health issues in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid inpatient treatment of severe female sexual dysfunction. Williams, W., Orsmond, A.[2017]

Citations

1. withpower.com withpower.com/trial/phase-persistent-genital-arousal-disorder-3-2023-05146

Group Cognitive Behavioural Therapy for Persistent ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/873bf7b4c3c5b520/nct05919784-effectiveness-group-cognitive-behavioural-treatment-persistent-genital-arousal-disorder

Examining the Effectiveness of a Group Cognitive-behavioural ... This study seeks to provide information regarding the effectiveness of a virtual, synchronous cognitive behavioural therapy (CBT) group program for women ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10228892/

Psychological Treatment of Persistent Genital Arousal ... The patient reported improvements anecdotally (e.g., decreased impact on occupational and social functioning, greater self-compassion, less ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05919784?cond=persistent%20genital%20arousal%20disorder&viewType=Table&rank=1

Examining the Effectiveness of a Group Cognitive ... This study seeks to provide information regarding the effectiveness of a virtual, synchronous cognitive behavioural therapy (CBT) group program for ...

5. trialx.com trialx.com/clinical-trials/listings/270319/examining-the-effectiveness-of-a-group-cognitive-behavioural-treatment-program-for-persistent-genital-arousal-disorder/

Clinical Research Trial Listing ( Persistent Genital Arousal ... This study seeks to provide information regarding the effectiveness of a virtual, synchronous cognitive behavioural therapy (CBT) group program for women with ...

6. tandfonline.com tandfonline.com/doi/full/10.1080/00224499.2024.2333477

Feasibility of a Cognitive-Behavioral Couple Therapy ... This pre-registered study tested the feasibility of a cognitive-behavioral couple therapy (CBCT) intervention for SIAD.