Anthesis - A Transdiagnostic Approach to Sexual Distress: Testing a Pilot Online Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Sexual Function Evaluation Questionnaire
研究概览
简要总结
This pilot study, named Anthesis, evaluates the preliminary efficacy of an online pilot study for sexual distress related to sexual function (SDRSF) in adults. Anthesis is theoretically anchored on a transdiagnostic CBT-based approach to SDRSF. The experience of sexual distress, especially sexual distress related to sexual function (SDRSF), is associated with poorer physical health, poorer mental health, and relational conflicts, which makes the development of theoretically and empirically sustained clinical interventions to eliminate or minimize it fundamental. In this project, the authors will attempt to answer the overall research question: "Does an online intervention aimed at transdiagnostic factors prove to have preliminary efficacy in reducing SDRSF?" Driven by both theory and empirical evidence on the comorbidity between emotional disorders and sexual dysfunctions, this project will focus on SDRSF (as a primary outcome variable). It will be considered a secondary outcome of sexual function and sexual pleasure.
Anthesis consists of eight modules (one module per week) delivered online. Participants will be divided into two conditions: an experimental condition that will start the intervention after the screening and a waiting list control condition (WLC) that will only begin its intervention after participants in the experimental condition have completed it.
详细描述
Background: According to DSM-5-TR and ICD-11, the experience of some level of sexual distress is an essential condition to establish a diagnosis of sexual dysfunction (SD). Recent research suggests high comorbidity between several clinical conditions and SD (e.g., between depression and decreased desire; between anxiety and orgasmic difficulties), as well as the presence of psychological processes (e.g., perfectionism, emotional dysregulation, worry) in the aetiology and maintenance of several SD. These processes are also common to other emotional disorders. This relation between vulnerability and maintenance factors of emotional disorders and SDs suggests that a transdiagnostic approach, which studies factors common to different emotional problems, will be adequate to intervene in SDRSF.
Research conducted worldwide indicates that most people facing distressing sexual problems do not actively seek or receive professional help. Many people feel ashamed to ask for health support for SDs and sexual problems. Additionally, various barriers-such as financial constraints, time limitations, long waiting lists, and a lack of specialists in sexual problems-hinder access to clinical support and negatively impact people's well-being and relationships. Therefore, the authors propose developing an online intervention that the literature indicates may increase accessibility to psychological interventions and help to overcome these barriers.
This project, focused on eliminating or reducing SDRSF, involves a pilot randomized controlled trial with participants divided into an intervention condition and a waiting list condition. Potential participants will be screened for eligibility using questionnaires to evaluate SDRSF, sexual function and general sexual distress on the intervention platform. After this, the eligibility criteria will be verified through screening during a clinical phone interview. Before starting the intervention, all participants will be informed about the study details on an informed consent form and will be given contact information from the research team for further clarification, if needed. The entire intervention will occur through a secure online platform. The Anthesis protocol aims to a) reduce sexual distress related to sexual function, b) improve sexual function, and c) increase sexual pleasure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •experiencing distress related to sexual function
- •understanding Portuguese
- •being over 18 years old
- •being in an exclusive (monogamic) romantic relationship for more than six months
- •Potential participants will be excluded if they are:
- •taking medication that interferes with the sexual response (e.g., antipsychotics, antidepressants, some types of hormone therapy or other)
- •having medical conditions that could impact the intervention outcomes (e.g., cancer, diabetes)
- •currently receiving psychological treatment, including psychological treatment for sexual dysfunctions or sexual problems
- •a transgender or intersex person
- •experiencing sexual pain
排除标准
- 未提供
研究组 & 干预措施
Intervention condition
Participants will access the treatment (Anthesis) by logging in to the platform. Each week, a new module is presented. During the week, participants can log onto the platform regularly to view each week's module, complete the homework presented at the end of each module, and proceed to the new module. Participants can contact the therapist through a written message during the intervention. All communication between the therapist and participants will occur exclusively through the platform.
干预措施: CBT-based transdiagnostic approach to sexual distress (Behavioral)
Waiting list control condition
The participants in the waiting list condition will not receive the intervention, while the participants in the experimental condition complete the protocol. However, participants in the waiting list condition have the option to contact the research team if their symptoms worsen or if they have any concerns related to the program. Once the participants in the experimental condition finish the intervention, the participants in the waiting list condition will then receive the intervention.
干预措施: Waiting list condition (Behavioral)
结局指标
主要结局
Change from Sexual Function Evaluation Questionnaire
时间窗: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
Sexual problems are assessed using the Sexual Function Evaluation Questionnaire (SFEQ), which includes 16 items divided into four factors: distress related to sexual function (factor 1), partner relationships (factor 2), overall sex life (factor 3), and sexual confidence (factor 4). Responses are based on individuals' experiences over the past month, with four different options available. Higher scores for Factors 1, 2, and 3, combined with lower scores for Factor 4, indicate poorer sexual function. In the overall evaluation, higher total scores also represent lower sexual function, with a minimum total score of 16 and a maximum total score of 64.
次要结局
- Change from Sexual Distress Scale(Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months)
- Change from International Index of Erectile Function(Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months)
- Change from Female Sexual Function Index(Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months)
- Change from Sexual Pleasure Scale(Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months)
研究者
Patrícia M. Pascoal
Professor
Grupo Lusófona