Female Sexual Dysfunction
Conditions
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.
Interventions
BEHAVIORALmylovia
Participants will receive access to the digital health intervention mylovia in addition to TAU.
Sponsors
Medical School Hamburg
Gaia AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sexual functioning | 3 months | Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | 3 months, 6 months | Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean more depressive symptomatology (worse outcome). |
| Sexual desire | 3 months, 6 months | 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). |
| Sexual satisfaction | 3 months, 6 months | New Sexual Satisfaction Scale - Short Form (NSS-SF). Total score ranging from 12 to 60; higher scores mean higher sexual satisfaction. |
| Sexual functioning | 6 months | Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cognitions and behaviors related to sexual pain | 3 months, 6 months | 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). |
Countries
Germany
Outcome results
None listed