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

NCT06823973 | Active Not Recruiting

• 1 other identifier: 2022.09087.PTDC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Sexual Distress; Sexual Dysfunctions

Keywords

Sexual distress related to sexual function; Sexual distress; Cognitive behavioural therapy; Transdiagnostic approach; Online intervention; Pilot study

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Change from Sexual Distress Scale

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

• Change from International Index of Erectile Function

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

• Change from Female Sexual Function Index

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

• Change from Sexual Pleasure Scale

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

Study Arms (2)

Intervention condition

EXPERIMENTAL

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

Waiting list control condition

OTHER

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

Interventions

CBT-based transdiagnostic approach to sexual distress BEHAVIORAL

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

Intervention condition

Waiting list condition BEHAVIORAL

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

Waiting list control condition

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Cisgender men Cisgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• experiencing distress related to sexual function
• understanding Portuguese
• being over 18 years old
• being in an exclusive (monogamic) romantic relationship for more than six months
• Potential participants will be excluded if they are:
• taking medication that interferes with the sexual response (e.g., antipsychotics, antidepressants, some types of hormone therapy or other)
• having medical conditions that could impact the intervention outcomes (e.g., cancer, diabetes)
• currently receiving psychological treatment, including psychological treatment for sexual dysfunctions or sexual problems
• a transgender or intersex person
• experiencing sexual pain

Sponsors & Collaborators

• Grupo Lusófona: lead

Study Sites (2)

Lusófona University

Lisbon, Portugal

Location

Universidade Lusófona- Centro Universitário de Lisboa

Lisbon, Portugal

Location

Related Publications (16)

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32402763 BACKGROUND

• 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.

  PMID: 39021678 BACKGROUND

• 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.

  PMID: 21054796 BACKGROUND

• 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.

  PMID: 38596387 BACKGROUND

• 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.

  PMID: 33121015 BACKGROUND

• 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.

  PMID: 39183638 BACKGROUND

• 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.

  PMID: 37958001 BACKGROUND

• 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.

  PMID: 37998422 BACKGROUND

• 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.

  PMID: 23088564 BACKGROUND

• 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.

  PMID: 18410300 BACKGROUND

• 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.

  PMID: 37232613 BACKGROUND

• 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.

  PMID: 19912503 BACKGROUND

• 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.

  PMID: 39786497 BACKGROUND

• 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.

  PMID: 38486121 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: March 7, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)