NCT Number: NCT06823973
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–64 year
All sexes
Interventional
Not applicable
Lusófona University, Lisbon, Portugal
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
The inclusion criteria are:
Potential participants will be excluded if they are:
It is constituted by 8 modules:
The participants in the waiting list condition will receive the intervention after the participants in the intervention condition.
Time frame: 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.
Time frame: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
Sexual distress is assessed using the Sexual Distress Scale (SDS), a unidimensional scale consisting of 12 items. Each item is evaluated on a Likert-type scale ranging from 0 to 4, with higher scores denoting increased sexual distress experienced over the past 30 days. The minimum score is 0, and the maximum total score is 48, with higher scores suggesting greater sexual distress.
Time frame: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
Male sexual function is assessed using the International Index of Erectile Function (IIEF), which consists of 15 items distributed across five factors: erectile function (factor 1), orgasmic function (factor 2), sexual desire (factor 3), intercourse satisfaction (factor 4), and overall satisfaction (factor 5). Each item is rated on a Likert-type scale from 0 to 5-where lower scores indicate greater male sexual dysfunction experienced over the last four weeks. In instances where no sexual activity occurred, a score of 0 is given. The maximum total score is 75, with lower overall scores suggesting an increased risk of sexual dysfunction.
Time frame: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
Female sexual function is measured using the Female Sexual Function Index (FSFI), which comprises 19 items distributed across six factors: desire (factor 1), arousal (factor 2), lubrication (factor 3), orgasm (factor 4), satisfaction (factor 5), and pain (factor 6). Each item is rated on a Likert-type scale ranging from 1 to 5-with lower scores indicating greater dysfunction over the past 4 weeks-and in cases where no sexual activity occurred, a score of 0 is assigned. The maximum total score is 36, with lower values suggesting a risk of sexual dysfunction.
Time frame: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
Sexual pleasure derived from sexual relationships, activities, and intimacy is assessed using the Sexual Pleasure Scale (SPS), a unidimensional scale that comprises 13 items. Each item on the scale is rated using a Likert-type scale ranging from 0 to 4, with higher scores indicating greater sexual pleasure. The minimum total score is 0, which represents no sexual pleasure, while the maximum score is 52, indicating the highest level of sexual pleasure experienced.
Grupo Lusófona
Other
Anthesis - A Transdiagnostic Approach to Sexual Distress: Testing a Pilot Online Intervention
Acronym: Anthesis
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