The diagnosis of Genito-Pelvic Pain/Penetration Disorder (GPPPD) was introduced in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and combines the previously separate categories of dyspareunia (sexual pain disorder) and vaginismus (sexual penetration disorder). This change was made due to the high overlap of symptoms and the lack of evidence for clear differential diagnostic distinctions (American Psychiatric Association, 2013). GPPPD is defined by four ma
Conditions
Interventions
Group 1: Participants in the intervention group will receive access to a self-help-based, guided, inclusive internet-based intervention (IMI) called “iJoy” for the treatment of Genito-Pelvic Pain Pene
Sponsors
Philipps-Universität Marburg, Arbeitsbereich eHealth der klinischen Psychologie und Psychotherapie
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Focus Groups and Think-Aloud Testing: Participants are eligible if they: - self-report that they meet the DSM-5 criteria for a diagnosis of Genito-Pelvic Pain Penetration Disorder (GPPPD) in the past, - speak and understand German fluently, - voluntarily provide written informed consent, and - have access to an internet-enabled device. RCT: For the evaluation study, participants must: - have been assigned female at birth and currently have female anatomy - be able to read and understand German sufficiently well, - voluntarily provide written informed consent, - have access to an internet-enabled device, and - meet the diagnostic criteria for GPPPD according to DSM-5, confirmed by trained study staff using the DISEX-F (Schwesig et al., 2024). Participants will be also asked in a self-report whether they have already undergone a medical evaluation to rule out medically treatable causes for their symptoms. If not, they will be encouraged to do so before continuing with the study. In addition, scores = 11 on the FSDS-R must indicate clinically relevant sexual distress (Derogatis et al., 2002).
Exclusion criteria
Exclusion criteria: RCT: Additional exclusion criteria assessed via self-report include: - current or past psychotic disorder, - current post-traumatic stress disorder (PTSD), - current alcohol or substance dependence, - current moderate to severe depression, - current mania, - or current pregnancy or within the first 8 weeks postpartum. - Women cannot participate if they are already receiving psychotherapy or any other treatment for GPPPD at study start, or if they are on a waiting list for another treatment during the study period. The diagnosis is made if at least one core criterion has been present for at least six months and the symptoms cannot be better explained by another nonsexual mental disorder, significant relationship distress (e.g., partner violence), or major stressors. The disorder should also not be solely attributable to the effects of a substance, medication, or a medical condition. Certain physical illnesses (e.g., current cancer treatment) that could make participation overly burdensome for the woman are also considered exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of sexual distress after 12 weeks, measured with the 13-item Female Sexual Distress Scale-Revised (FSDS-R; Derogatis et al., 2008). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Severity of GPPPD symptoms: This will be assessed using the Penetration Pain Questionnaire (PenPainQ; Schweigert et al., in preparation), a recently developed questionnaire designed to provide a precise and valid measure of symptom severity and individual impairment caused by genito-pelvic pain/penetration disorder (31 items). Initial validation results are already available. • Difficulties with vaginal penetration: Measured by the Primary Endpoint Questionnaire (PEQ; Van Lankveld et al., 2006), which includes seven items. • Muscle tension: Assessed using subscales of the Multidimensional Vaginal Penetration Disorder Questionnaire (MVPDQ; Molaeinezhad et al., 2014), which contains ten items covering various dimensions of muscle tension and spasms. • Fear related to sexual activities: Measured using the 10-item Fear of Sexuality Questionnaire (FSQ; Ter Kuile et al., 2007). • Impairment due to pain: Assessed using the brief, three-item scale of the Diagnostic Guidelines for the Assessment of GPPPD (Binik, 2010). • Sexual function and pain during sexual activities: Assessed using the Female Sexual Function Index (FSFI; Berner et al., 2004), a 19-item questionnaire. • Diagnostic confirmation of GPPPD and other sexual dysfunctions: Conducted via the Diagnostic Interview for Sexual Dysfunction, which is administered by telephone and based on DSM-5 and ICD-11 criteria (Schwesig et al., 2024). • Sexual satisfaction: Assessed using the six-item satisfaction subscale of the Sexual Satisfaction Scale for Women (SSS-W; Meston & Trapnell, 2005). • Anxiety and depressive symptoms: Measured using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4; Kroenke et al., 2009), which is a brief, four-item instrument. Additionally, the short version of the Sexual Distress Scale (SDS-3; Lin et al., 2024) will be used to assess sexual distress at interim measurement points. | — |
Countries
Germany
Contacts
Public ContactAnna-Carlotta Zarski
Philipps-Universität Marburg, Arbeitsbereich eHealth der klinischen Psychologie und Psychotherapie
Outcome results
None listed