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

Gaia AG

Status: Active, not recruiting

Conditions: Female Sexual Dysfunction

Treatments: Behavioral: mylovia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06237166

mylovia RCT

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

mylovia + TAU

Experimental group

Description:

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.

Treatment:

Behavioral: mylovia

information material + TAU

No Intervention group

Description:

Participants allocated to the control group will receive access to information material about treatment and counseling options in addition to treatment as usual (TAU).