Clinical trial NCT06237166: Evaluation of an Online Intervention for Female Sexual Dysfunction
Official title: Evaluation of an Online Intervention for Female Sexual Dysfunction: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Female Sexual Dysfunction
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: Medical School Hamburg
First posted: 2024-02-01
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: sexual functioning
timeFrame: 3 months
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 3 months, 6 months
measure: Sexual desire
timeFrame: 3 months, 6 months
measure: Sexual satisfaction
timeFrame: 3 months, 6 months
measure: Sexual functioning
timeFrame: 6 months
Other outcomes:
measure: Cognitions and behaviors related to sexual pain
timeFrame: 3 months, 6 months
Locations:
city: Hamburg
country: Germany
facility: GAIA
Study officials:
affiliation: Medical School Hamburg
name: Johanna Schröder, PhD
role: PRINCIPAL_INVESTIGATOR
References: