Trials / Active Not Recruiting
Active Not RecruitingNCT06823973
Anthesis: A Transdiagnostic Cognitive-Behavioral Therapy (CBT)-Based Approach to Sexual Distress: Testing a Pilot Online Intervention
Anthesis - A Transdiagnostic Approach to Sexual Distress: Testing a Pilot Online Intervention
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Grupo Lusófona · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | CBT-based transdiagnostic approach to sexual distress | It is constituted by 8 modules: 1. Psychoeducation about sexual function 2. Difficulties in emotional regulation 3. Non-judgmental emotional awareness 4. Cognitive flexibility 5. Worry and rumination 6. Perfectionism 7. Communication 8. Summary |
| BEHAVIORAL | Waiting list condition | The participants in the waiting list condition will receive the intervention after the participants in the intervention condition. |
Timeline
- Start date
- 2025-03-07
- Primary completion
- 2025-06-01
- Completion
- 2025-09-01
- First posted
- 2025-02-12
- Last updated
- 2025-05-07
Locations
2 sites across 1 country: Portugal
Source: ClinicalTrials.gov record NCT06823973. Inclusion in this directory is not an endorsement.