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

Study Overview
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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).

Official Title
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Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia

Conditions
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Persistent Genital Arousal Disorder

Intervention / Treatment
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* Behavioral: Cognitive behavioural therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioural therapy<br>The group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT). | Behavioral: Cognitive behavioural therapy<br>* The group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | Baseline | 
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | Week 1 of program | 
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | Week 2 of program | 
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | Week 3 of program | 
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | Week 4 of program | 
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | Week 5 of program | 
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | Week 6 of program | 
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | Week 7 of program | 
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | Week 8 of program | 
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | 3 months after the end of the program | 
| Symptom intensity | Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse. | 6 months after the end of the program | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | Baseline | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | Week 1 of program | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | Week 2 of program | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | Week 3 of program | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | Week 4 of program | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | Week 5 of program | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | Week 6 of program | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | Week 7 of program | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | Week 8 of program | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | 3 months after the end of the program | 
| Symptom distress | Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse. | 6 months after the end of the program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | Baseline | 
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | Week 1 of program | 
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | Week 2 of program | 
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | Week 3 of program | 
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | Week 4 of program | 
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | Week 5 of program | 
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | Week 6 of program | 
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | Week 7 of program | 
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | Week 8 of program | 
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | 3 months after the end of the program | 
| Symptom catastrophizing | Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse. | 6 months after the end of the program | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | Baseline | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | Week 1 of program | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | Week 2 of program | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | Week 3 of program | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | Week 4 of program | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | Week 5 of program | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | Week 6 of program | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | Week 7 of program | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | Week 8 of program | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | 3 months after the end of the program | 
| Symptom self-efficacy | Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better. | 6 months after the end of the program | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | Baseline | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | Week 1 of program | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | Week 2 of program | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | Week 3 of program | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | Week 4 of program | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | Week 5 of program | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | Week 6 of program | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | Week 7 of program | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | Week 8 of program | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | 3 months after the end of the program | 
| Resilience | Brief Resilience Scale. Range is 6-30. Higher scores are better. | 6 months after the end of the program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent Genital Arousal Disorder, intervention