Avatar-based Therapy for Female Orgasmic Disorder

Female Orgasmic Disorder Clinical Trial

Official title:

An Avatar-based Intervention in Second Life for Female Orgasmic Disorder: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06187246
• Other study ID #: UniversidadRJC 2005202114121
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2023
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial was conducted for testing the efficacy of a novel avatar-based intervention (IG), that was compared with a control group (CG) for women with female orgasmic disorder (FOD). Participants were 31 women who were randomly assigned to the intervention or the control conditions. Intervention was based on the cognitive behavioral therapy approach (treatment with the most empirical evidence) and previous literature about FOD. It consisted of 12 weekly online individual sessions and aimed at improving the FOD diagnosis, sexual variables, and variables that are known to affect orgasm consecution. Control group was based on minimum therapeutic contact. Changes over time in the assessed variables were analyzed using linear mixed models, considering treatment group, measurement time point, and group-by-time interactions as fixed effects. Effect sizes were computed (Cohen's d; number needed to treat - NNT; reliable change index - RCI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Present the characteristics to diagnose female orgasm disorder after a clinic assessment (considering natural characteristics of the women's sexual response cycle (Conn & Hodges, 2022) based on the DSM-5 criteria.
• Provide a medical check to prove the absence of physical factors that may be the cause of the orgasm dysfunction, as this is the first part to diagnose FOD.
• Be at least 18 years old (adult).
• Have access to a computer with the characteristics to run Second Life and internet connection.

Exclusion Criteria:

• Present a diagnosis of a physical condition that may be the cause of the orgasm dysfunction (e.g., genital lesions, systemic and hormonal factors, vulvovaginal atrophy).
• Presence of other psychological pathology (e.g., depression, trauma) that may be the cause of the orgasm dysfunction.
• Have alcohol dependence (i.e., evaluated during the clinical assessment, according to the diagnostic criteria from the DSM-5, to determine if the individual meets the criteria for an alcohol use disorder diagnosis).
• Drug use, including medication that is known to cause sexual difficulties (e.g., selective serotonin reuptake inhibitors (SSRIs), that are a particularly common drug cause of sexual dysfunction.
• Have participated in a previous psychological intervention in the last year.

Related Conditions & MeSH terms

• Female Orgasmic Disorder
• Sexual Dysfunctions, Psychological

Intervention

Behavioral:
• Avatar-based intervention
Intervention was aimed at improving sexual variables (sexual satisfaction, sexual function, and initiative and sexual communication), and variables that are known to affect orgasm consecution (sexual self-esteem, sex-guilt, and sexual anxiety). To achieve this objective, it focused on fostering participants' abilities to increase their levels of sexual stimulation, and the engagement in personal values, along with identifying and modifying dysfunctional thoughts about sexuality. The techniques used included psychosexual education, cognitive restructuring, virtual exposure, sexual stimulation, and engagement in personal values from the acceptance and commitment therapy (ACT) perspective. It was delivered via a metaverse: Second Life.

Other:
• Individual informative talks
Participants were provided with information about female orgasm (e.g., what is an orgasm, neuronal orgasm, factors that may influence consecution, sexual response), masturbatory techniques (e.g., key elements to achieve pleasure, anatomy of the female genitalia, pleasure areas) and techniques to focus attention on one's body (i.e., an important factor to pleasure). Participants received three individual sessions once a month, and had a duration of one hour.

Locations

Country	Name	City	State
Spain	Rey Juan Carlos University	Alcorcon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual satisfaction assessed by the Golombok Rust Inventory of Sexual Satisfaction	Sexual satisfaction is the feeling of pleasure that one has when the sexual desire has been fulfilled.; The Golombok Rust Inventory of Sexual Satisfaction has minimum-maximum values of 0-112; higher scores mean a worse outcome. The cut-off for determining significant levels of Sexual Satisfaction is 60 (scores equal to or above 60 indicate the existence of a sexual problem).	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Primary	Sexual functionassessed by the Female Sexual Function Index	Sexual function refers to the capacity of having a satisfactory sexual life. The Female Sexual Function Index has minimum-maximum values of 19-95; higher scores mean a better outcome. The cut-off for determining signi?cant levels of this variable is 55 (scores equal to or below 55 indicate poor Sexual Function).	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Primary	Initiative and Sexual Communication assessed by the Female Sexual Function Questionnaire	Initiative and Sexual Communication is the proactive and consensual expression of one's sexual desires, interests, and intentions within the context of a sexual relationship or encounter.; The Female Sexual Function Questionnaire has minimum-maximum values of 14-70; higher scores mean a better outcome. The cut-off for determining significantly low levels of this variable are scores equal to or lower than 25.	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Secondary	Sexual self-esteem assessed by the Rosenberg Self-Esteem Scale	Self-esteem related to sexuality; may influence on the consecution of orgasms. The Rosenberg Self-Esteem Scale has minimum-maximum values of 10-40; higher scores mean a better outcome. The cut-off for clinical low self-esteem is a score equal to or lower than 25.	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Secondary	Sex-guilt assessed by the Brief Mosher Sex-Guilt Scale	Sex-guilt related to sexuality; may influence on the consecution of orgasms. The Brief Mosher Sex-Guilt Scale has minimum-maximum values of 10-60; higher scores mean a worse outcome (higher scores indicate higher levels of guilt).	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Secondary	Sexual anxiety by the Sexual Anxiety scale of the Expanded Sexual Arousability Inventory	Sexual anxiety related to sexualiaty; may influence on the consecution of orgasms.; TheSexual Anxiety scale of the Expanded Sexual Arousability Inventory has minimum-maximum values of 0-168; higher scores mean a worse outcome (higher scores indicate higher levels of sexual anxiety).	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up