Zarski Anna-Carlotta, Berking Matthias, Ebert David Daniel
Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.
Institute of Psychology, Leuphana University Lüneburg, Lüneburg, Germany.
Front Psychiatry. 2018 Jan 22;8:260. doi: 10.3389/fpsyt.2017.00260. eCollection 2017.
Genito-pelvic pain/penetration disorder (GPPPD) not only adversely affects women's sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce.
This article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an Internet-based guided intervention for GPPPD.
Two hundred women who meet the criteria for GPPPD and have not been able to experience sexual intercourse for at least the last 6 months will be recruited and randomly assigned either to the intervention group (IG) or a 6-month waitlist control group. Assessments take place at baseline (T1), peritreatment after completion of Session 5 in IG (T2), after completion of Session 8 or 12 weeks after randomization (T3), and after 6 months (T4). Data will be analyzed on an intention-to-treat and a completer basis.
The primary outcome will be sexual intercourse involving the insertion of the partner's penis at posttreatment. Secondary outcomes include, e.g., improved non-intercourse penetration, sexual functioning, dyadic stress coping, reduced fear of sexuality and negative penetration-related cognitions. Fear of sexuality, penetration-related cognitions, and exercise intensity will be assessed as mediators of intercourse in the IG. Sexual dysfunctions of partners will be measured at baseline (T1) and investigated as a potential moderator of the primary treatment outcome.
Given the burden associated with GPPPD and the need for specialized treatment, there is a surprising lack of evidence-based treatment options. This study aims to assess whether Internet-based interventions could contribute to closing this treatment gap.
German Register of Clinical Studies (DRKS): DRKS00010228.
生殖器-盆腔疼痛/插入障碍（GPPPD）不仅会对女性的性功能和性满意度产生不利影响，还与一系列心理社会后果相关，如生活质量和幸福感下降、心理健康合并症以及关系困扰。有效治疗方案的证据稀缺。
本文描述了一项随机对照试验的基本原理、治疗方案和研究设计，该试验旨在检验基于互联网的指导性干预对GPPPD的疗效。
招募200名符合GPPPD标准且在过去至少6个月内无法进行性交的女性，并将她们随机分配到干预组（IG）或6个月的等待名单对照组。评估在基线（T1）、IG完成第5次治疗后的治疗期间（T2）、随机分组后完成第8次治疗或12周后（T3）以及6个月后（T4）进行。数据将在意向性分析和完成者分析的基础上进行分析。
主要结局将是治疗后涉及伴侣阴茎插入的性交。次要结局包括，例如，非性交插入改善、性功能、二元应激应对、对性的恐惧降低以及与插入相关的负面认知减少。对性的恐惧、与插入相关的认知以及运动强度将作为IG中性交的调节因素进行评估。伴侣的性功能障碍将在基线（T1）进行测量，并作为主要治疗结局的潜在调节因素进行研究。
鉴于GPPPD带来的负担以及对专门治疗的需求，令人惊讶的是缺乏基于证据的治疗方案。本研究旨在评估基于互联网的干预是否有助于填补这一治疗空白。
德国临床研究注册中心（DRKS）：DRKS00010228。
