A randomized-controlled feasibility study of internet-based cognitive behavioral therapy and mindfulness-based therapy for hypoactive sexual desire dysfunction in women with comorbid depression

基于互联网的认知行为疗法和正念疗法治疗共病抑郁症女性性欲功能减退的随机对照可行性研究

• 批准号: 531778085
• 负责人: Privatdozentin Dr. Julia Velten
• 金额: --
• 依托单位: Lehrstuhl für Klinische Psychologie und Psychotherapie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/531778085?language=en
• 关键词: randomized; controlled; feasibility; study; internet

Hypoactive sexual desire dysfunction (HSDD), characterized by a clinically significant reduction or absence of sexual desire, is one of the most common sexual dysfunctions among women. While HSDD affects about 7% of women in Germany annually, its prevalence in clinical populations, especially among women with depressive disorders, is much higher. While there is considerable evidence that cognitive behavioral therapy (CBT) and mindfulness-based therapy (MBT) are both effective treatments for HSDD, most women do not receive treatment. This undertreatment of HSDD is even more pronounced in women with depression who are usually excluded from research trials on HSDD and whose sexual concerns are frequently ignored by their mental health care providers. Among the reasons for this are that mental health care providers (e.g., psychiatrists) consider treatment of sexual problems to be of secondary importance, do not feel qualified to provide treatment, or have the (often false) assumption that HSDD will automatically improve once the comorbid mental disorder is remitted. This proposal aims to close this research and treatment gap by developing two internet-based programs following either a CBT or MBT approach (i.e., iCBT and iMBT), using a patient-centered iterative treatment development process, and then providing extensive feasibility data to inform a larger-scale confirmative trial. In Phase 1 of this proposal, two focus-group studies will be conducted to gather comprehensive information on the treatment preferences of the target population, to generate ideas about what content and therapeutic exercises could be most relevant, and to obtain detailed feedback on key treatment components (e.g., case vignettes) based on prototypes of the interventions. As part of this process, participants will work through the content of the iCBT and iMBT interventions while verbalizing their thoughts and providing detailed feedback on the experience. In Phase 2, the main feasibility study, a total of 80 women will be randomized to either iCBT or iMBT. Both quantitative and qualitative data assessments will be conducted at six and twelve weeks after inclusion. In this phase, feasibility data (i.e., the feasibility of recruitment and adherence, treatment satisfaction, safety and risks, as well as preliminary treatment efficacy) will be assessed. Data of Phase 2 will be evaluated based on a traffic-light system (i.e., red: “do not proceed”, yellow: “revise and improve, green: “proceed to larger trial”) to determine the feasibility and time-scale of a larger-scale confirmatory trial. This proposal is a crucial step in providing evidence-based psychological care for sexual concerns to women with comorbid mental disorders, a population whose highly prevalent sexual problems remain under-researched as well as under-served in clinical practice.

性欲减退性功能障碍（HSDD）是女性最常见的性功能障碍之一，其特征在于临床上显著的性欲降低或缺乏。虽然每年德国约有7%的女性患有HSDD，但其在临床人群中的患病率，特别是在患有抑郁症的女性中，要高得多。虽然有相当多的证据表明认知行为疗法（CBT）和正念疗法（MBT）都是治疗HSDD的有效方法，但大多数女性没有接受治疗。这种对HSDD的治疗不足在抑郁症女性中更为明显，她们通常被排除在HSDD的研究试验之外，而且她们的性问题经常被精神卫生保健提供者忽视。其中一个原因是精神卫生保健提供者（例如，精神科医生）认为性问题的治疗是次要的，不觉得有资格提供治疗，或有（往往是错误的）假设，一旦共病精神障碍缓解，HSDD将自动改善。该提案旨在通过开发两个基于互联网的项目来缩小这一研究和治疗差距，这两个项目采用CBT或MBT方法（即，iCBT和iMBT），使用以患者为中心的迭代治疗开发过程，然后提供广泛的可行性数据，为更大规模的验证性试验提供信息。在该提案的第一阶段，将进行两项焦点小组研究，以收集目标人群治疗偏好的全面信息，产生关于哪些内容和治疗练习最相关的想法，并获得关键治疗成分的详细反馈（例如，案例插图）基于干预措施的原型。作为这一过程的一部分，参与者将通过iCBT和iMBT干预措施的内容，同时口头表达他们的想法，并提供详细的反馈经验。在第2阶段，即主要的可行性研究中，共有80名女性将随机接受iCBT或iMBT。将在入选后6周和12周进行定量和定性数据评估。在此阶段，可行性数据（即，招募的可行性和依从性、治疗满意度、安全性和风险以及初步治疗疗效）。第二阶段的数据将根据交通灯系统进行评估（即，红色：“不继续”，黄色：“修订和改进，绿色：“继续进行更大规模的试验”），以确定更大规模验证性试验的可行性和时间范围。这一建议是一个关键的一步，在提供循证心理护理的性问题的妇女与共病的精神障碍，人口的高度流行的性问题仍然研究不足，以及在临床实践中服务不足。