Avatar-based Therapy for Female Orgasmic Disorder

Not Applicable

Completed

• Conditions: Female Orgasmic Disorder
• Interventions: Other: Individual informative talks; Behavioral: Avatar-based intervention

• Registration Number: NCT06187246
• Lead Sponsor: Universidad Rey Juan Carlos

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-29
• Last Update Submitted: 2023-12-29
• Study First Posted: 2024-01-02
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimal support control group	Individual informative talks	It consisted in individual informative talks, during which they 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.
Avatar-based Intervention Group	Avatar-based intervention	Treatment was based on the CBT approach and previous literature about FOD. It consisted of 12 weekly online individual sessions, which were administered once a week (total duration = 3 months) and lasted about 60 minutes each.

Primary Outcome Measures

Name	Time	Method
Initiative and Sexual Communication assessed by the Female Sexual Function Questionnaire	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up	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.
Sexual satisfaction assessed by the Golombok Rust Inventory of Sexual Satisfaction	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up	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).
Sexual functionassessed by the Female Sexual Function Index	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up	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 significant levels of this variable is 55 (scores equal to or below 55 indicate poor Sexual Function).

Secondary Outcome Measures

Name	Time	Method
Sexual self-esteem assessed by the Rosenberg Self-Esteem Scale	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up	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.
Sex-guilt assessed by the Brief Mosher Sex-Guilt Scale	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up	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).
Sexual anxiety by the Sexual Anxiety scale of the Expanded Sexual Arousability Inventory	From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up	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).

Trial Locations

Locations (1)

Rey Juan Carlos University; 🇪🇸 Alcorcon, Madrid, Spain