Evaluation of an Online Intervention for Female Sexual Dysfunction

Female Sexual Dysfunction Clinical Trial

— FELYCIA  

Official title:

Evaluation of an Online Intervention for Female Sexual Dysfunction: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237166
• Other study ID #: mylovia RCT
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: May 2, 2025

Study information

• Verified date: June 2024
• Source: Gaia AG
• Contact: Gitta A. Jacob, PhD
• Phone: +49.40.349930-374
• Email: gitta.jacob[@]gaia-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this randomized controlled clinical trial, 250 participants with female sexual dysfunction will be investigated regarding the effectiveness of an online intervention for improving sexual function, the unguided online intervention mylovia. Inclusion criteria are: female sex and female gender, age ≥18, diagnosed sexual dysfunction (ICD-11: HA00, HA01, HA02) or sexual pain disorder (ICD-11: HA20), low sexual functioning (<27 on the Female Sexual Function Index; FSFI), sufficient German skills, and consent to participation. Exclusion criteria are: biological, psychological or social factors that might interfere with study participation, and use of another digital intervention for sexual problems. Participants will be randomized and allocated to either an intervention group, receiving access to mylovia in addition to treatment as usual (TAU), or a control group, receiving information material about treatment and counseling options in addition to TAU. Primary endpoint will be sexual functioning assessed via FSFI, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be sexual desire, sexual satisfaction, sexual pain, and general psychopathology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 2, 2025
• Est. primary completion date: May 2, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female sex

• female gender

• age = 18 years

• diagnosis of sexual dysfunction (ICD-11: HA00, HA01, HA02) or sexual pain disorder (ICD-11: HA20), diagnosed via the DISEX-F interview

• Sexual function score (cut-off) of <27 on the FSFI

• consent to participation

• sufficient knowledge of the German language

Exclusion Criteria:

• Use of another digital intervention for sexual problems

In general, given that sexual dysfunction is a biopsychosocial phenomenon, mylovia is hypothesized to help women irrespective of the disorder's etiology (i.e., biological, psychological, or social). However, if one of the domains is extremely compromised, mylovia might not be expedient. Therefore, a clinical assessment of factors that might interfere with study assessment will be conducted, with the following additional exclusion criteria:

• Biological factors that might interfere with study participation (e.g., cancer, multiple sclerosis)

• Psychological factors that might interfere with study participation (e.g., schizophrenia, bipolar disorder, borderline personality disorder, eating disorder, post-traumatic stress disorder, severe depression, suicidality, substance use disorder)

• Social factors that might interfere with study participation (e.g. severe partnership problems)

Related Conditions & MeSH terms

• Female Sexual Dysfunction

Intervention

Behavioral:
• mylovia
Participants will receive access to the digital health intervention mylovia in addition to TAU.

Locations

Country	Name	City	State
Germany	GAIA	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Gaia AG	Medical School Hamburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitions and behaviors related to sexual pain	Self-compiled instrument assessing cognitions and behaviors related to sexual pain. Total score ranging from 0-100; higher scores mean more maladaptive cognitions and behaviors related to sexual pain (worse outcome).	3 months, 6 months
Primary	sexual functioning	Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome).	3 months
Secondary	Depressive symptoms	Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean more depressive symptomatology (worse outcome).	3 months, 6 months
Secondary	Sexual desire	Sexual Interest and Desire Inventory - Female - Self-Report (SIDI-F-SR). Total score ranging from 0-51; higher scores mean higher levels of sexual desire (better outcome).	3 months, 6 months
Secondary	Sexual satisfaction	New Sexual Satisfaction Scale - Short Form (NSS-SF). Total score ranging from 12 to 60; higher scores mean higher sexual satisfaction.	3 months, 6 months
Secondary	Sexual functioning	Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome).	6 months