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

• Sponsor: Queen's University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05919784
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 43.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Persistent Genital Arousal Disorder	Behavioral: Cognitive behavioural therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia
• Actual Study Start Date: Apr 24, 2023
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Symptom intensity [Baseline]

   Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

2. Symptom intensity [Week 1 of program]

   Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

3. Symptom intensity [Week 2 of program]

   Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

4. Symptom intensity [Week 3 of program]

   Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

5. Symptom intensity [Week 4 of program]

   Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

6. Symptom intensity [Week 5 of program]

   Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

7. Symptom intensity [Week 6 of program]

   Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

8. Symptom intensity [Week 7 of program]

   Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

9. Symptom intensity [Week 8 of program]

   Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

10. Symptom intensity [3 months after the end of the program]

    Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

11. Symptom intensity [6 months after the end of the program]

    Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.

12. Symptom distress [Baseline]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

13. Symptom distress [Week 1 of program]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

14. Symptom distress [Week 2 of program]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

15. Symptom distress [Week 3 of program]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

16. Symptom distress [Week 4 of program]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

17. Symptom distress [Week 5 of program]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

18. Symptom distress [Week 6 of program]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

19. Symptom distress [Week 7 of program]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

20. Symptom distress [Week 8 of program]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

21. Symptom distress [3 months after the end of the program]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

22. Symptom distress [6 months after the end of the program]

    Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.

Secondary Outcome Measures

1. Symptom catastrophizing [Baseline]

   Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

2. Symptom catastrophizing [Week 1 of program]

   Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

3. Symptom catastrophizing [Week 2 of program]

   Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

4. Symptom catastrophizing [Week 3 of program]

   Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

5. Symptom catastrophizing [Week 4 of program]

   Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

6. Symptom catastrophizing [Week 5 of program]

   Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

7. Symptom catastrophizing [Week 6 of program]

   Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

8. Symptom catastrophizing [Week 7 of program]

   Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

9. Symptom catastrophizing [Week 8 of program]

   Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

10. Symptom catastrophizing [3 months after the end of the program]

    Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

11. Symptom catastrophizing [6 months after the end of the program]

    Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.

12. Symptom self-efficacy [Baseline]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

13. Symptom self-efficacy [Week 1 of program]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

14. Symptom self-efficacy [Week 2 of program]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

15. Symptom self-efficacy [Week 3 of program]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

16. Symptom self-efficacy [Week 4 of program]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

17. Symptom self-efficacy [Week 5 of program]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

18. Symptom self-efficacy [Week 6 of program]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

19. Symptom self-efficacy [Week 7 of program]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

20. Symptom self-efficacy [Week 8 of program]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

21. Symptom self-efficacy [3 months after the end of the program]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

22. Symptom self-efficacy [6 months after the end of the program]

    Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.

23. Resilience [Baseline]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

24. Resilience [Week 1 of program]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

25. Resilience [Week 2 of program]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

26. Resilience [Week 3 of program]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

27. Resilience [Week 4 of program]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

28. Resilience [Week 5 of program]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

29. Resilience [Week 6 of program]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

30. Resilience [Week 7 of program]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

31. Resilience [Week 8 of program]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

32. Resilience [3 months after the end of the program]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

33. Resilience [6 months after the end of the program]

    Brief Resilience Scale. Range is 6-30. Higher scores are better.

Other Outcome Measures

1. Sexual distress [Baseline]

   Sexual distress scale. Range is 0-20. Higher scores are worse.

2. Sexual distress [Week 4 of program]

   Sexual distress scale. Range is 0-20. Higher scores are worse.

3. Sexual distress [Week 8 of program]

   Sexual distress scale. Range is 0-20. Higher scores are worse.

4. Sexual distress [3 months after the end of the program]

   Sexual distress scale. Range is 0-20. Higher scores are worse.

5. Sexual distress [6 months after the end of the program]

   Sexual distress scale. Range is 0-20. Higher scores are worse.

6. Anxiety [Baseline]

   Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.

7. Anxiety [Week 4 of program]

   Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.

8. Anxiety [Week 8 of program]

   Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.

9. Anxiety [3 months after the end of the program]

   Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.

10. Anxiety [6 months after the end of the program]

    Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.

11. Depression [Baseline]

    Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.

12. Depression [Week 4 of program]

    Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.

13. Depression [Week 8 of program]

    Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.

14. Depression [3 months after the end of the program]

    Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.

15. Depression [6 months after the end of the program]

    Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.

16. Symptom-related disability [Baseline]

    Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.

17. Symptom-related disability [Week 4 of program]

    Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.

18. Symptom-related disability [Week 8 of program]

    Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.

19. Symptom-related disability [3 months after the end of the program]

    Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.

20. Symptom-related disability [6 months after the end of the program]

    Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.

21. Sexual function [Baseline]

    Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.

22. Sexual function [Week 4 of program]

    Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.

23. Sexual function [Week 8 of program]

    Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.

24. Sexual function [3 months after the end of the program]

    Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.

25. Sexual function [6 months after the end of the program]

    Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.

26. Alliance [Week 1 of program]

    Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.

27. Alliance [Week 2 of program]

    Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.

28. Alliance [Week 3 of program]

    Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.

29. Alliance [Week 4 of program]

    Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.

30. Alliance [Week 5 of program]

    Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.

31. Alliance [Week 6 of program]

    Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.

32. Alliance [Week 7 of program]

    Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.

33. Alliance [Week 8 of program]

    Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.

34. Therapy group cohesion [Week 1 of program]

    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.

35. Therapy group cohesion [Week 2 of program]

    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.

36. Therapy group cohesion [Week 3 of program]

    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.

37. Therapy group cohesion [Week 4 of program]

    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.

38. Therapy group cohesion [Week 5 of program]

    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.

39. Therapy group cohesion [Week 6 of program]

    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.

40. Therapy group cohesion [Week 7 of program]

    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.

41. Therapy group cohesion [Week 8 of program]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sexual Health Research Laboratory, Department of Psychology, Queen's University	Kingston	Ontario	Canada	K7L 3N6

Sponsors and Collaborators

• Queen's University

Investigators

• Principal Investigator: Caroline Pukall, PhD, Queen's University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Caroline Pukall, Professor, Queen's University
• ClinicalTrials.gov Identifier: NCT05919784
• Other Study ID Numbers: 379631-3
• First Posted: Jun 26, 2023
• Last Update Posted: Jun 26, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Caroline Pukall, Professor, Queen's University: Persistent Genital Arousal Disorder; intervention

Study Results

No Results Posted as of Jun 26, 2023