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

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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.