Anthesis: A Transdiagnostic Cognitive-Behavioral Therapy (CBT)-Based Approach to Sexual Distress: Testing a Pilot Online Intervention (Anthesis)

May 3, 2025 updated by: Patrícia M. Pascoal, Grupo Lusófona

Anthesis - A Transdiagnostic Approach to Sexual Distress: Testing a Pilot Online Intervention

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisboa, Portugal
        • Universidade Lusófona- Centro Universitário de Lisboa
      • Lisbon, Portugal
        • Lusofona University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Other: 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.
Behavioral: Waiting list condition
The participants in the waiting list condition will receive the intervention after the participants in the intervention condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Sexual Function Evaluation Questionnaire
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.
Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Sexual Distress Scale
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.
Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
Change from International Index of Erectile Function
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.
Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
Change from Female Sexual Function Index
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.
Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months
Change from Sexual Pleasure Scale
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.
Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Lusófona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022.09087.PTDC (Other Identifier: Fundação para a Ciência e a Tecnologia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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