Group Cognitive Behavioural Therapy for Persistent Genital Arousal Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Caroline Pukall, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dr. Caroline Pukall

Disqualifiers: Under 18, Nonfluent English, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder?

Cognitive-behavioral therapy (CBT) has been shown to improve sexual function in other contexts, such as in pregnant women, and has been part of an integrative approach that helped a patient with persistent genital arousal disorder (PGAD) experience improvements in quality of life and symptom management. ^{1 2 3 4 5}

How is the Group Cognitive Behavioural Therapy treatment for Persistent Genital Arousal Disorder different from other treatments?

Group Cognitive Behavioural Therapy (CBT) for Persistent Genital Arousal Disorder is unique because it uses a structured, psychological approach to help manage symptoms, focusing on changing thought patterns and behaviors, unlike other treatments that may not address the psychological aspects. This is particularly novel as there are no established treatments for this condition, and CBT has shown effectiveness in improving sexual function in other contexts. ^{2 3 4 6 7}

Research Team

Caroline Pukall, PhD

Principal Investigator

Kingston Health Sciences Centre

Eligibility Criteria

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.

Reside in Ontario, Canada

Fluent in English

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.

I am under 18 years old.

Trial Timeline

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

Treatment Details

Interventions

• Group Cognitive-behavioural Treatment Program (Behavioral Intervention)

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.

Participant Groups

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+

Marie Evangelista

Queen's University

Chief Executive Officer

PhD in Cell and Molecular Biology from Queen's University, Ontario, Canada

Constantine Kreatsoulas

Queen's University

Chief Medical Officer since 2021

PhD in Chemistry from Princeton University

Findings from Research

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]

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 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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Rapid inpatient treatment of severe female sexual dysfunction. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Persistent genital arousal disorder: a review of the literature and recommendations for management. [2015]

3. Iran pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive-behavioral therapy on sexual function and sexual self-efficacy in pregnant women: An RCT. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Hypnotherapy for persistent genital arousal disorder: a case study. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Psychological Treatment of Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia Using an Integrative Approach. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A periclitoral mass as a cause of persistent genital arousal disorder. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Persistent Genital Arousal Disorder (PGAD): A Clinical Review and Case Series in Support of Multidisciplinary Management. [2022]