Clinical trial NCT06187246: Avatar-based Therapy for Female Orgasmic Disorder
Official title: An Avatar-based Intervention in Second Life for Female Orgasmic Disorder: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Orgasmic Disorder
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 \&amp; 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.

Primary outcomes:
measure: Sexual satisfaction assessed by the Golombok Rust Inventory of Sexual Satisfaction
timeFrame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
measure: Sexual functionassessed by the Female Sexual Function Index
timeFrame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
measure: Initiative and Sexual Communication assessed by the Female Sexual Function Questionnaire
timeFrame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Secondary outcomes:
measure: Sexual self-esteem assessed by the Rosenberg Self-Esteem Scale
timeFrame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
measure: Sex-guilt assessed by the Brief Mosher Sex-Guilt Scale
timeFrame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
measure: Sexual anxiety by the Sexual Anxiety scale of the Expanded Sexual Arousability Inventory
timeFrame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Rey Juan Carlos University
state: Madrid
Study officials:
References: