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Sexual DistressAnthesisNCT06823973

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

A study testing CBT-based transdiagnostic approach to sexual distress and Waiting list condition in people with Sexual Distress and Sexual Dysfunctions, run by Grupo Lusófona at 2 sites in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Sexual Distress, Sexual Dysfunctions
What is being tested?
CBT-based transdiagnostic approach to sexual distress and Waiting list condition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesPortugal
Study dates
7 Mar 2025to Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

2 sites in 1 country.

Portugal2 sites

  • Lusófona University

    Lisbon

  • Universidade Lusófona- Centro Universitário de Lisboa

    Lisbon

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Being tested
CBT-based transdiagnostic approach to sexual distress, Waiting list condition
Keywords
Sexual distress related to sexual function, Sexual distress, Cognitive behavioural therapy, Transdiagnostic approach, Online intervention, Pilot study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT-based transdiagnostic approach to sexual distressBehavioural

    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

  • Waiting list conditionBehavioural

    The participants in the waiting list condition will receive the intervention after the participants in the intervention condition.

Study groups in NCT06823973
Study groupRoleWhat they receive
Intervention conditionExperimentalParticipants 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.
Receives: Behavioral: CBT-based transdiagnostic approach to sexual distress
Waiting list control conditionOtherThe 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.
Receives: Behavioral: Waiting list condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Sexual Function Evaluation Questionnaire

    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.

    Measured: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months

Secondary outcomes (4)

  1. Change from Sexual Distress Scale

    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.

    Measured: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months

  2. Change from International Index of Erectile Function

    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.

    Measured: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months

  3. Change from Female Sexual Function Index

    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.

    Measured: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months

  4. Change from Sexual Pleasure Scale

    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.

    Measured: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2025
  2. Study start7 Mar 2025
  3. Primary completionJun 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06823973
Sponsor's protocol ID
2022.09087.PTDC
Other IDs
2022.09087.PTDC
Acronym
Anthesis
Status last verified
May 2025
First submitted
6 Feb 2025
Last updated
7 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make IPD available.

Publications

  • Guerreiro, P. P., Raposo, C. F., Salvador, Á., Manão, A. A., & Pascoal, P. M. (2024). A transdiagnostic approach to sexual distress and pleasure: The role of worry, rumination, and emotional regulation. Current Psychology, 43(17), 15385-15396.

  • American Psychiatric Association. (2022). Diagnostic and statistical manual of mental disorders (5th ed., text rev.). American Psychiatric Association. https://doi.org/10.1176/appi.books.9780890425787

  • Tavares IM, Moura CV, Nobre PJ. The Role of Cognitive Processing Factors in Sexual Function and Dysfunction in Women and Men: A Systematic Review. Sex Med Rev. 2020 Jul;8(3):403-430. doi: 10.1016/j.sxmr.2020.03.002. Epub 2020 May 10.

    PubMed 32402763

  • Raposo CF, Nobre PJ, Manao AA, Pascoal PM. Understanding sexual distress related to sexual function (SDRSF): A preliminary framework based on a qualitative study with clinical sexologists. Int J Clin Health Psychol. 2024 Jul-Sep;24(3):100473. doi: 10.1016/j.ijchp.2024.100473. Epub 2024 Jun 24.

    PubMed 39021678

  • Quinta Gomes AL, Nobre P. Personality traits and psychopathology on male sexual dysfunction: an empirical study. J Sex Med. 2011 Feb;8(2):461-9. doi: 10.1111/j.1743-6109.2010.02092.x. Epub 2010 Nov 3.

    PubMed 21054796

  • Peixoto MM, Ribeiro V. Repetitive Negative Thinking and Sexual Functioning in Portuguese Men and Women: A Cross-Sectional Study. Int J Sex Health. 2022 Jun 7;34(4):567-576. doi: 10.1080/19317611.2022.2084201. eCollection 2022.

    PubMed 38596387

  • Pascoal PM, Raposo CF, Roberto MS. A Transdiagnostic Approach to Sexual Distress and Sexual Pleasure: A Preliminary Mediation Study with Repetitive Negative Thinking. Int J Environ Res Public Health. 2020 Oct 27;17(21):7864. doi: 10.3390/ijerph17217864.

    PubMed 33121015

  • Martins EM, Pascoal PM, Manao AA, Rosa PJ. The Interplay of Worry and Relationship Satisfaction to Understand Sexual Distress: An APIM Study with Heterosexual Couples Using Cross-Sectional Data. J Sex Marital Ther. 2024;50(7):878-893. doi: 10.1080/0092623X.2024.2391390. Epub 2024 Aug 26.

    PubMed 39183638

  • Manao AA, Martins E, Pascoal PM. What Sexual Problems Does a Sample of LGB+ People Report Having, and How Do They Define Sexual Pleasure: A Qualitative Study to Inform Clinical Practice. Healthcare (Basel). 2023 Oct 30;11(21):2856. doi: 10.3390/healthcare11212856.

    PubMed 37958001

  • Manao AA, Pascoal PM. Body Dissatisfaction, Cognitive Distraction, and Sexual Satisfaction in a Sample of LGB+ People: A Mediation Study Framed by Cognitive Psychology Models of Sexual Response. Healthcare (Basel). 2023 Nov 9;11(22):2930. doi: 10.3390/healthcare11222930.

    PubMed 37998422

  • Hendrickx L, Gijs L, Enzlin P. Distress, sexual dysfunctions, and DSM: dialogue at cross purposes? J Sex Med. 2013 Mar;10(3):630-41. doi: 10.1111/j.1743-6109.2012.02971.x. Epub 2012 Oct 22.

    PubMed 23088564

  • Hayes RD, Dennerstein L, Bennett CM, Sidat M, Gurrin LC, Fairley CK. Risk factors for female sexual dysfunction in the general population: exploring factors associated with low sexual function and sexual distress. J Sex Med. 2008 Jul;5(7):1681-93. doi: 10.1111/j.1743-6109.2008.00838.x.

    PubMed 18410300

  • Costa IB, Manao AA, Pascoal PM. Clinical Sexologists' Perceptions of the Potentials, Downfalls, and Best Practices for Digitally Delivered Therapy: A Lesson from Lockdown Due to COVID-19 in Portugal. Behav Sci (Basel). 2023 May 4;13(5):376. doi: 10.3390/bs13050376.

    PubMed 37232613

  • Carvalho J, Nobre P. Predictors of women's sexual desire: the role of psychopathology, cognitive-emotional determinants, relationship dimensions, and medical factors. J Sex Med. 2010 Feb;7(2 Pt 2):928-37. doi: 10.1111/j.1743-6109.2009.01568.x. Epub 2009 Nov 13.

    PubMed 19912503

  • Brotto LA, Atallah S, Carvalho J, Gordon E, Pascoal PM, Reda M, Stephenson KR, Tavares IM. Psychological and interpersonal dimensions of sexual function and dysfunction: recommendations from the fifth international consultation on sexual medicine (ICSM 2024). Sex Med Rev. 2025 Apr 14;13(2):118-143. doi: 10.1093/sxmrev/qeae073.

    PubMed 39786497

Questions about this trial

What is this clinical trial studying?

A study testing CBT-based transdiagnostic approach to sexual distress and Waiting list condition in people with Sexual Distress and Sexual Dysfunctions, run by Grupo Lusófona at 2 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Sexual Function Evaluation Questionnaire (time frame: Baseline, post-intervention assessment (8 weeks after the baseline) and follow-up assessments at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06823973, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.

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