Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Symptom distress
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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).
Intervention: Cognitive behavioural therapy (Behavioral)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcomes
- Symptom catastrophizing(6 months after the end of the program)
- Symptom self-efficacy(6 months after the end of the program)
- Resilience(6 months after the end of the program)
- Symptom self-efficacy(Week 1 of program)
- 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)
- Symptom catastrophizing(Week 5 of program)
- Symptom catastrophizing(Week 6 of program)
- Symptom catastrophizing(Week 7 of program)
- Symptom catastrophizing(Week 8 of program)
- Symptom catastrophizing(3 months after the end of the program)
- Symptom self-efficacy(Baseline)
- Symptom self-efficacy(Week 2 of program)
- Symptom self-efficacy(Week 3 of program)
- Symptom self-efficacy(Week 4 of program)
- Symptom self-efficacy(Week 5 of program)
- Symptom self-efficacy(Week 6 of program)
- Symptom self-efficacy(Week 7 of program)
- Symptom self-efficacy(Week 8 of program)
- Symptom self-efficacy(3 months after the end of the program)
- Resilience(Baseline)
- Resilience(Week 1 of program)
- Resilience(Week 2 of program)
- Resilience(Week 3 of program)
- Resilience(Week 4 of program)
- Resilience(Week 5 of program)
- Resilience(Week 6 of program)
- Resilience(Week 7 of program)
- Resilience(Week 8 of program)
- Resilience(3 months after the end of the program)
Investigators
Dr. Caroline Pukall
Professor
Queen's University