Anthesis: A Transdiagnostic Cognitive-Behavioral Therapy (CBT)-Based Approach to Sexual Distress: Testing a Pilot Online Intervention
NCT ID: NCT06823973
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-03-07
2025-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Online Exposure Therapy for Obsessive-Compulsive Disorder (OCD) Study
NCT06470893
Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder
NCT00057603
Targeting Taboo Thoughts In Obsessive-Compulsive Disorder
NCT04313439
iCBT for Adult Obsessive-Compulsive Disorder
NCT07081438
Acceptance and Commitment Therapy for Problematic Chemsex
NCT06408545
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
Waiting list condition
The participants in the waiting list condition will receive the intervention after the participants in the intervention condition.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Waiting list condition
The participants in the waiting list condition will receive the intervention after the participants in the intervention condition.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Grupo Lusófona
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Patrícia M. Pascoal
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lusófona University
Lisbon, , Portugal
Universidade Lusófona- Centro Universitário de Lisboa
Lisbon, , Portugal
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Beato AF, Pascoal PM, Rodrigues J. The impact of digital media on sexuality: a descriptive and qualitative study. Int J Impot Res. 2024 Nov;36(7):770-780. doi: 10.1038/s41443-024-00865-y. Epub 2024 Mar 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022.09087.PTDC
Identifier Type: OTHER
Identifier Source: secondary_id
2022.09087.PTDC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.