Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder

NCT ID: NCT05919784

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2025-05-31

Brief Summary

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This study seeks to provide information regarding the effectiveness of a virtual, synchronous cognitive behavioural therapy (CBT) group program for women with Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia (PGAD/GPD). The program consists of 8 weekly sessions of two hours each, which focus on education and understanding, and learning skills and strategies to manage PGAD/GPD symptoms, and related mental health and lifestyle impacts, as well as structured opportunities for discussion and shared reflection. The group therapy program involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT). Participants in the present study will provide responses to online surveys (before, during, and immediately after treatment, also 3 and 6 months after treatment) regarding their PGAD/GPD symptoms, mental health symptoms, and sexual wellness (sexual pleasure and distress).

Detailed Description

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Conditions

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Persistent Genital Arousal Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive behavioural therapy

The group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT).

Group Type EXPERIMENTAL

Cognitive behavioural therapy

Intervention Type BEHAVIORAL

The group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT).

Interventions

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Cognitive behavioural therapy

The group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age
* fluent in English
* have a physician-based diagnosis of PGAD/GPD
* reside in Ontario, Canada
* be comfortable answering questions about their health (mental and physical) and sexuality in online surveys
* be comfortable discussing their mental and physical health and PGAD/GPD symptoms in group online therapy sessions with video on

Exclusion Criteria

* under the age of 18 years
* nonfluent in English
* lack of physician based diagnosis of PGAD/GPD
* not comfortable with answering questions about mental, physical, sexual health
* not comfortable with discussing mental and physical health and PGAD/GPD symptoms in group online therapy sessions with video on
* mental or physical health conditions that preclude involvement in group therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Caroline Pukall

OTHER

Sponsor Role lead

Responsible Party

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Dr. Caroline Pukall

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Caroline Pukall, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Sexual Health Research Laboratory, Department of Psychology, Queen's University

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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379631-3

Identifier Type: -

Identifier Source: org_study_id

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