NCT05919784

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

June 13, 2023

Last Update Submit

April 30, 2026

Conditions

Persistent Genital Arousal Disorder

Keywords

Persistent Genital Arousal Disorderintervention

Outcome Measures

Primary Outcomes (22)

  • 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 Outcomes (33)

  • Symptom catastrophizing

    Baseline

  • Symptom catastrophizing

    Week 1 of program

  • Symptom catastrophizing

    Week 2 of program

  • Symptom catastrophizing

    Week 3 of program

  • Symptom catastrophizing

    Week 4 of program

  • +28 more secondary outcomes

Other Outcomes (41)

  • Sexual distress

    Baseline

  • Sexual distress

    Week 4 of program

  • Sexual distress

    Week 8 of program

  • +38 more other outcomes

Study Arms (1)

Cognitive behavioural therapy

EXPERIMENTAL

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

Interventions

Cognitive behavioural therapyBEHAVIORAL

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

Cognitive behavioural therapy

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAnyone who self-identifies as a woman is eligible to participate.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Caroline Pukall, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 26, 2023

Study Start

April 24, 2023

Primary Completion

August 31, 2024

Study Completion

May 31, 2025

Last Updated

May 6, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

De-identified data will be available to other researchers after publication of the results.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
De-identified data will be available to other researchers for 2 years after publication of the results.
Access Criteria
Please email the PI at caroline.pukall@queensu.ca

Locations

CA(1)