Clinical trial NCT05919784: Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder
Official title: Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Persistent Genital Arousal Disorder
Keywords: Persistent Genital Arousal Disorder
intervention
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Symptom intensity
timeFrame: Baseline
measure: Symptom intensity
timeFrame: Week 1 of program
measure: Symptom intensity
timeFrame: Week 2 of program
measure: Symptom intensity
timeFrame: Week 3 of program
measure: Symptom intensity
timeFrame: Week 4 of program
measure: Symptom intensity
timeFrame: Week 5 of program
measure: Symptom intensity
timeFrame: Week 6 of program
measure: Symptom intensity
timeFrame: Week 7 of program
measure: Symptom intensity
timeFrame: Week 8 of program
measure: Symptom intensity
timeFrame: 3 months after the end of the program
measure: Symptom intensity
timeFrame: 6 months after the end of the program
measure: Symptom distress
timeFrame: Baseline
measure: Symptom distress
timeFrame: Week 1 of program
measure: Symptom distress
timeFrame: Week 2 of program
measure: Symptom distress
timeFrame: Week 3 of program
measure: Symptom distress
timeFrame: Week 4 of program
measure: Symptom distress
timeFrame: Week 5 of program
measure: Symptom distress
timeFrame: Week 6 of program
measure: Symptom distress
timeFrame: Week 7 of program
measure: Symptom distress
timeFrame: Week 8 of program
measure: Symptom distress
timeFrame: 3 months after the end of the program
measure: Symptom distress
timeFrame: 6 months after the end of the program
Secondary outcomes:
measure: Symptom catastrophizing
timeFrame: Baseline
measure: Symptom catastrophizing
timeFrame: Week 1 of program
measure: Symptom catastrophizing
timeFrame: Week 2 of program
measure: Symptom catastrophizing
timeFrame: Week 3 of program
measure: Symptom catastrophizing
timeFrame: Week 4 of program
measure: Symptom catastrophizing
timeFrame: Week 5 of program
measure: Symptom catastrophizing
timeFrame: Week 6 of program
measure: Symptom catastrophizing
timeFrame: Week 7 of program
measure: Symptom catastrophizing
timeFrame: Week 8 of program
measure: Symptom catastrophizing
timeFrame: 3 months after the end of the program
measure: Symptom catastrophizing
timeFrame: 6 months after the end of the program
measure: Symptom self-efficacy
timeFrame: Baseline
measure: Symptom self-efficacy
timeFrame: Week 1 of program
measure: Symptom self-efficacy
timeFrame: Week 2 of program
measure: Symptom self-efficacy
timeFrame: Week 3 of program
measure: Symptom self-efficacy
timeFrame: Week 4 of program
measure: Symptom self-efficacy
timeFrame: Week 5 of program
measure: Symptom self-efficacy
timeFrame: Week 6 of program
measure: Symptom self-efficacy
timeFrame: Week 7 of program
measure: Symptom self-efficacy
timeFrame: Week 8 of program
measure: Symptom self-efficacy
timeFrame: 3 months after the end of the program
measure: Symptom self-efficacy
timeFrame: 6 months after the end of the program
measure: Resilience
timeFrame: Baseline
measure: Resilience
timeFrame: Week 1 of program
measure: Resilience
timeFrame: Week 2 of program
measure: Resilience
timeFrame: Week 3 of program
measure: Resilience
timeFrame: Week 4 of program
measure: Resilience
timeFrame: Week 5 of program
measure: Resilience
timeFrame: Week 6 of program
measure: Resilience
timeFrame: Week 7 of program
measure: Resilience
timeFrame: Week 8 of program
measure: Resilience
timeFrame: 3 months after the end of the program
measure: Resilience
timeFrame: 6 months after the end of the program
Other outcomes:
measure: Sexual distress
timeFrame: Baseline
measure: Sexual distress
timeFrame: Week 4 of program
measure: Sexual distress
timeFrame: Week 8 of program
measure: Sexual distress
timeFrame: 3 months after the end of the program
measure: Sexual distress
timeFrame: 6 months after the end of the program
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: Week 4 of program
measure: Anxiety
timeFrame: Week 8 of program
measure: Anxiety
timeFrame: 3 months after the end of the program
measure: Anxiety
timeFrame: 6 months after the end of the program
measure: Depression
timeFrame: Baseline
measure: Depression
timeFrame: Week 4 of program
measure: Depression
timeFrame: Week 8 of program
measure: Depression
timeFrame: 3 months after the end of the program
measure: Depression
timeFrame: 6 months after the end of the program
measure: Symptom-related disability
timeFrame: Baseline
measure: Symptom-related disability
timeFrame: Week 4 of program
measure: Symptom-related disability
timeFrame: Week 8 of program
measure: Symptom-related disability
timeFrame: 3 months after the end of the program
measure: Symptom-related disability
timeFrame: 6 months after the end of the program
measure: Sexual function
timeFrame: Baseline
measure: Sexual function
timeFrame: Week 4 of program
measure: Sexual function
timeFrame: Week 8 of program
measure: Sexual function
timeFrame: 3 months after the end of the program
measure: Sexual function
timeFrame: 6 months after the end of the program
measure: Alliance
timeFrame: Week 1 of program
measure: Alliance
timeFrame: Week 2 of program
measure: Alliance
timeFrame: Week 3 of program
measure: Alliance
timeFrame: Week 4 of program
measure: Alliance
timeFrame: Week 5 of program
measure: Alliance
timeFrame: Week 6 of program
measure: Alliance
timeFrame: Week 7 of program
measure: Alliance
timeFrame: Week 8 of program
measure: Therapy group cohesion
timeFrame: Week 1 of program
measure: Therapy group cohesion
timeFrame: Week 2 of program
measure: Therapy group cohesion
timeFrame: Week 3 of program
measure: Therapy group cohesion
timeFrame: Week 4 of program
measure: Therapy group cohesion
timeFrame: Week 5 of program
measure: Therapy group cohesion
timeFrame: Week 6 of program
measure: Therapy group cohesion
timeFrame: Week 7 of program
measure: Therapy group cohesion
timeFrame: Week 8 of program
Locations:
city: Kingston
country: Canada
facility: Sexual Health Research Laboratory, Department of Psychology, Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Caroline Pukall, PhD
role: PRINCIPAL_INVESTIGATOR
References: