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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Persistent Genital Arousal Disorder
• Intervention / Treatment: Behavioral: Cognitive behavioural therapy

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Pukall, PhD; Phone Number: 613 533 3200; Email: caroline.pukall@queensu.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3N6
      • Recruiting
      • Sexual Health Research Laboratory, Department of Psychology, Queen's University
      • Contact: Caroline Pukall, PhD; Phone Number: 613 533 3200; Email: caroline.pukall@queensu.ca
      • Contact: Shannon Coyle, MA; Phone Number: 613 533 3276; Email: shannon.coyle13@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual distress	Sexual distress scale. Range is 0-20. Higher scores are worse.	Baseline
Sexual distress	Sexual distress scale. Range is 0-20. Higher scores are worse.	Week 4 of program
Sexual distress	Sexual distress scale. Range is 0-20. Higher scores are worse.	Week 8 of program
Sexual distress	Sexual distress scale. Range is 0-20. Higher scores are worse.	3 months after the end of the program
Sexual distress	Sexual distress scale. Range is 0-20. Higher scores are worse.	6 months after the end of the program
Anxiety	Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.	Baseline
Anxiety	Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.	Week 4 of program
Anxiety	Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.	Week 8 of program
Anxiety	Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.	3 months after the end of the program
Anxiety	Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.	6 months after the end of the program
Depression	Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.	Baseline
Depression	Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.	Week 4 of program
Depression	Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.	Week 8 of program
Depression	Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.	3 months after the end of the program
Depression	Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.	6 months after the end of the program
Symptom-related disability	Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.	Baseline
Symptom-related disability	Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.	Week 4 of program
Symptom-related disability	Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.	Week 8 of program
Symptom-related disability	Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.	3 months after the end of the program
Symptom-related disability	Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.	6 months after the end of the program
Sexual function	Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.	Baseline
Sexual function	Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.	Week 4 of program
Sexual function	Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.	Week 8 of program
Sexual function	Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.	3 months after the end of the program
Sexual function	Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.	6 months after the end of the program
Alliance	Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.	Week 1 of program
Alliance	Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.	Week 2 of program
Alliance	Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.	Week 3 of program
Alliance	Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.	Week 4 of program
Alliance	Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.	Week 5 of program
Alliance	Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.	Week 6 of program
Alliance	Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.	Week 7 of program
Alliance	Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.	Week 8 of program
Therapy group cohesion	The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.	Week 1 of program
Therapy group cohesion	The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.	Week 2 of program
Therapy group cohesion	The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.	Week 3 of program
Therapy group cohesion	The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.	Week 4 of program
Therapy group cohesion	The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.	Week 5 of program
Therapy group cohesion	The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.	Week 6 of program
Therapy group cohesion	The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.	Week 7 of program
Therapy group cohesion	The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.	Week 8 of program

Collaborators and Investigators

• Sponsor: Dr. Caroline Pukall
• Investigators: Principal Investigator: Caroline Pukall, PhD, Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: intervention; Persistent Genital Arousal Disorder
• Other Study ID Numbers: 379631-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be available to other researchers after publication of the results.
• IPD Sharing Time Frame: De-identified data will be available to other researchers for 2 years after publication of the results.
• IPD Sharing Access Criteria: Please email the PI at caroline.pukall@queensu.ca
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No