Evaluation of an Online Intervention for Female Sexual Dysfunction (FELYCIA)

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

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.

Study Overview

• Status: Completed
• Conditions: Female Sexual Dysfunction
• Intervention / Treatment: Behavioral: mylovia

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22085
    • GAIA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mylovia + TAU; Participants allocated to the intervention group will receive access to mylovia in addition to treatment as usual (TAU). mylovia is a digital health application designed for women with sexual dysfunction, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by mylovia are psychoeducation, relaxation and mindfulness exercises, strategies to improve self-esteem, development of passionate attitudes and situations, dealing with differences in desire in a relationship, and sensate focus exercises. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.	Behavioral: mylovia; Participants will receive access to the digital health intervention mylovia in addition to TAU.
No Intervention: information material + TAU; Participants allocated to the control group will receive access to information material about treatment and counseling options in addition to treatment as usual (TAU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sexual functioning	Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Sexual functioning	Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome).	6 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gaia AG
• Collaborators: Medical School Hamburg
• Investigators: Principal Investigator: Johanna Schröder, PhD, Medical School Hamburg

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Actual): February 10, 2025
• Study Completion (Actual): May 8, 2025

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: mylovia RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No