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Completed

NCT Number: NCT05919784

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

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).

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Key information

Conditions

Persistent Genital Arousal Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kingston, Ontario, K7L 3N6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioural Therapy

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).

Primary outcomes

  1. Symptom intensity

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Symptom catastrophizing

    Time frame: Baseline

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

  2. Symptom catastrophizing

    Time frame: Week 1 of program

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

  3. Symptom catastrophizing

    Time frame: Week 2 of program

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

  4. Symptom catastrophizing

    Time frame: Week 3 of program

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

  5. Symptom catastrophizing

    Time frame: Week 4 of program

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

  6. Symptom catastrophizing

    Time frame: Week 5 of program

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

  7. Symptom catastrophizing

    Time frame: Week 6 of program

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

  8. Symptom catastrophizing

    Time frame: Week 7 of program

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

  9. Symptom catastrophizing

    Time frame: Week 8 of program

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

  10. Symptom catastrophizing

    Time frame: 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

    Time frame: 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

    Time frame: Baseline

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

  13. Symptom self-efficacy

    Time frame: Week 1 of program

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

  14. Symptom self-efficacy

    Time frame: Week 2 of program

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

  15. Symptom self-efficacy

    Time frame: Week 3 of program

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

  16. Symptom self-efficacy

    Time frame: Week 4 of program

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

  17. Symptom self-efficacy

    Time frame: Week 5 of program

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

  18. Symptom self-efficacy

    Time frame: Week 6 of program

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

  19. Symptom self-efficacy

    Time frame: Week 7 of program

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

  20. Symptom self-efficacy

    Time frame: Week 8 of program

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

  21. Symptom self-efficacy

    Time frame: 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

    Time frame: 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

    Time frame: Baseline

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

  24. Resilience

    Time frame: Week 1 of program

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

  25. Resilience

    Time frame: Week 2 of program

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

  26. Resilience

    Time frame: Week 3 of program

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

  27. Resilience

    Time frame: Week 4 of program

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

  28. Resilience

    Time frame: Week 5 of program

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

  29. Resilience

    Time frame: Week 6 of program

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

  30. Resilience

    Time frame: Week 7 of program

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

  31. Resilience

    Time frame: Week 8 of program

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

  32. Resilience

    Time frame: 3 months after the end of the program

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

  33. Resilience

    Time frame: 6 months after the end of the program

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

Other outcomes

  1. Sexual distress

    Time frame: Baseline

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

  2. Sexual distress

    Time frame: Week 4 of program

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

  3. Sexual distress

    Time frame: Week 8 of program

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

  4. Sexual distress

    Time frame: 3 months after the end of the program

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

  5. Sexual distress

    Time frame: 6 months after the end of the program

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

  6. Anxiety

    Time frame: Baseline

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

  7. Anxiety

    Time frame: Week 4 of program

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

  8. Anxiety

    Time frame: Week 8 of program

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

  9. Anxiety

    Time frame: 3 months after the end of the program

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

  10. Anxiety

    Time frame: 6 months after the end of the program

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

  11. Depression

    Time frame: Baseline

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

  12. Depression

    Time frame: Week 4 of program

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

  13. Depression

    Time frame: Week 8 of program

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

  14. Depression

    Time frame: 3 months after the end of the program

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

  15. Depression

    Time frame: 6 months after the end of the program

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

  16. Symptom-related disability

    Time frame: Baseline

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

  17. Symptom-related disability

    Time frame: Week 4 of program

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

  18. Symptom-related disability

    Time frame: Week 8 of program

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

  19. Symptom-related disability

    Time frame: 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

    Time frame: 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

    Time frame: Baseline

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

  22. Sexual function

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr. Caroline Pukall

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 26, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

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