Clinical trial NCT06823973: Anthesis: A Transdiagnostic Cognitive-Behavioral Therapy (CBT)-Based Approach to Sexual Distress: Testing a Pilot Online Intervention
Official title: Anthesis - A Transdiagnostic Approach to Sexual Distress: Testing a Pilot Online Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sexual Distress
Sexual Dysfunctions
Keywords: Sexual distress related to sexual function
Sexual distress
Cognitive behavioural therapy
Transdiagnostic approach
Online intervention
Pilot study
Lead sponsor: Grupo Lusófona
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: The inclusion criteria are:

1. experiencing distress related to sexual function
2. understanding Portuguese
3. being over 18 years old
4. being in an exclusive (monogamic) romantic relationship for more than six months

Potential participants will be excluded if they are:

1. taking medication that interferes with the sexual response (e.g., antipsychotics, antidepressants, some types of hormone therapy or other)
2. having medical conditions that could impact the intervention outcomes (e.g., cancer, diabetes)
3. currently receiving psychological treatment, including psychological treatment for sexual dysfunctions or sexual problems
4. a transgender or intersex person
5. experiencing sexual pain

Primary outcomes:
measure: Change from Sexual Function Evaluation Questionnaire
timeFrame: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
Secondary outcomes:
measure: Change from Sexual Distress Scale
timeFrame: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
measure: Change from International Index of Erectile Function
timeFrame: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
measure: Change from Female Sexual Function Index
timeFrame: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
measure: Change from Sexual Pleasure Scale
timeFrame: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Universidade Lusófona- Centro Universitário de Lisboa
city: Lisbon
country: Portugal
facility: Lusófona University
Study officials:
References:
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