Internet-Based Guided Self-Help for Genito-Pelvic Pain/Penetration Disorder - Randomized Controlled Proof-of-Concept Trial

Internet-Based Guided Self-Help for Genito-Pelvic Pain/Penetration Disorder - Randomized Controlled Proof-of-Concept Trial - Paivina-Care Online Health Training

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010228

Enrollment

200

Registered

2016-05-23

Start date

2016-04-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DSM-V: Genito-Pelvic Pain/Penetration Disorder F52.5 F52.6

Interventions

Group 1: Intervention group: Online-training consisting of 8 lessons and one booster session four weeks after completing the training. Each session could be completed in approximately 30 to 45 minutes

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • No ability to have sexual intercourse at least in the last 6 months due to GPPPD (Primary Endpoint Questionnaire, German adaptation, van Lankveld et al., 2006) • Age of 18 or older • Currently in a heterosexual relationship or having a sexual partner (Sociodemographic Questionnaire) • GPPPD not attributable to a medical condition, diagnosed by a gynaecologist/other specialist (self-report) • Internet access (Sociodemographic Questionnaire) • Willing to give informed consent and to fill out questionnaires

Exclusion criteria

Exclusion criteria: • Current or past psychotic or dissociative symptoms (Sociodemographic questionnaire) • Currently present or past post-traumatic stress disorder (SKID screening) • Present alcohol abuse or dependency (AUDIT = 6) • Moderate or severe depression (PHQ, Cut-Off = 4) • Current bipolar disorder (Sociodemographic questionnaire) • Currently being in psychotherapy for GPPD (Sociodemographic questionnaire)

Design outcomes

Primary

Measure	Time frame
The ability to engage in vaginal penetration (Primary Endpoint Questionnaire, German adaptation, van Lankveld et al., 2006), prior to randomization/start of the training (baseline), during the training (after completion of lesson 5, about 5 weeks after randomization), after training completion (completion of lesson 8 or max. 12 weeks after the randomization) and at the 6 months follow-up (6 months after randomization).	—

Measure

Time frame

The ability to engage in vaginal penetration (Primary Endpoint Questionnaire, German adaptation, van Lankveld et al., 2006), prior to randomization/start of the training (baseline), during the training (after completion of lesson 5, about 5 weeks after randomization), after training completion (completion of lesson 8 or max. 12 weeks after the randomization) and at the 6 months follow-up (6 months after randomization).

—

Secondary

Measure	Time frame
• Sociodemographic Questionnaire (pretest) • Vaginismus Questionnaire (descriptive survey) (pretest) • Demographic Questionnaire for partner (pretest) • Female Sexual Function Index, German adaptation (Berner, Kriston, Zahradnik, Härter, & Rohde, 2004) (pretest, peritest, posttest, 6-M-FU) • Fear of Sexuality Questionnaire, German adaptation (ter Kuile et al., 2007) (pretest, peritest, posttest, 6-M-FU) • Relationship Questionnaire, short version (Kliam, Job, Kröger, Bodenmann, Richter, Hahlweg, & Brähler, 2012) (pretest, posttest, 6-M-FU) • Generalized Anxiety Disorder 7-item (GAD-7) scale (GAD-7; Spitzer, Koenke, Williams, & Löwe, 2006) (pretest, posttest, 6-M-FU) • State Trait Anxiety Inventory (STAI-T; Laux, Glanzmann, Schaffner, & Spielberger, 1981) (pretest, posttest, 6-M-FU) • Self Esteem Scale (Rosenberg, 1965) (pretest, posttest, 6-M-FU) • Dyadic Coping Inventory (Bodenmann, 2008, 2010) (pretest, posttest, 6-M-FU) • Vaginal Penetration Cognition Questionnaire (VPCQ; Klaassen & ter Kuile, 2009) (pretest, peri, posttest, 6-M-FU) • Well-Being Index (WHO-5; Bech, 2004), psychological well-being/resilience (pretest, posttest, 6-M-FU) • HAPA Questionnaire (based on Schwarzer et al., 2003): Assessment of motivational and volitional variables referring to the Health Action Process Aprroach (pretest, peritest) • International Index of Erectile Function for Men (IIEF; Rosen et al., 1997) (pretest) • Utilization of Additional Help Questionnaire (self development) (posttest, 6-M-FU) • Client satisfaction in Web-based Interventions Questionnaire (CSWIQ-8; Boß et al, in prep., based on the Client Satisfaction Questionnaire (ZUF-8; Schmidt, Lamprecht &, Wittmann, 1989) and the Client Satisfaction Questionnaire (CSQ; Attkisson & Zwick, 1982))(posttest) • Reasons for Dropout Questionnaire (self development) (posttest, 6-M-FU) • Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, & Nestoriuc, 2014) (posttest, 6-M-FU)	—

Measure

Time frame

• Sociodemographic Questionnaire (pretest) • Vaginismus Questionnaire (descriptive survey) (pretest) • Demographic Questionnaire for partner (pretest) • Female Sexual Function Index, German adaptation (Berner, Kriston, Zahradnik, Härter, & Rohde, 2004) (pretest, peritest, posttest, 6-M-FU) • Fear of Sexuality Questionnaire, German adaptation (ter Kuile et al., 2007) (pretest, peritest, posttest, 6-M-FU) • Relationship Questionnaire, short version (Kliam, Job, Kröger, Bodenmann, Richter, Hahlweg, & Brähler, 2012) (pretest, posttest, 6-M-FU) • Generalized Anxiety Disorder 7-item (GAD-7) scale (GAD-7; Spitzer, Koenke, Williams, & Löwe, 2006) (pretest, posttest, 6-M-FU) • State Trait Anxiety Inventory (STAI-T; Laux, Glanzmann, Schaffner, & Spielberger, 1981) (pretest, posttest, 6-M-FU) • Self Esteem Scale (Rosenberg, 1965) (pretest, posttest, 6-M-FU) • Dyadic Coping Inventory (Bodenmann, 2008, 2010) (pretest, posttest, 6-M-FU) • Vaginal Penetration Cognition Questionnaire (VPCQ; Klaassen & ter Kuile, 2009) (pretest, peri, posttest, 6-M-FU) • Well-Being Index (WHO-5; Bech, 2004), psychological well-being/resilience (pretest, posttest, 6-M-FU) • HAPA Questionnaire (based on Schwarzer et al., 2003): Assessment of motivational and volitional variables referring to the Health Action Process Aprroach (pretest, peritest) • International Index of Erectile Function for Men (IIEF; Rosen et al., 1997) (pretest) • Utilization of Additional Help Questionnaire (self development) (posttest, 6-M-FU) • Client satisfaction in Web-based Interventions Questionnaire (CSWIQ-8; Boß et al, in prep., based on the Client Satisfaction Questionnaire (ZUF-8; Schmidt, Lamprecht &, Wittmann, 1989) and the Client Satisfaction Questionnaire (CSQ; Attkisson & Zwick, 1982))(posttest) • Reasons for Dropout Questionnaire (self development) (posttest, 6-M-FU) • Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, & Nestoriuc, 2014) (posttest, 6-M-FU)

—

Countries

Germany

Contacts

Public ContactAnna-Carlotta Zarski

Lehrstuhl für Klinische Psychologie und Psychotherapie (KliPs)Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)

anna-carlotta.zarski@fau.de09131 - 85 - 67570

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 24, 2026