A randomized-controlled feasibility study of internet-based cognitive behavioral therapy and mindfulness-based therapy for hypoactive sexual desire dysfunction in women with comorbid depression

A randomized-controlled feasibility study of internet-based cognitive behavioral therapy and mindfulness-based therapy for hypoactive sexual desire dysfunction in women with comorbid depression - Depressive MOod and Sexual DESire (MODES)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038681

Enrollment

100

Registered

2026-05-29

Start date

2026-06-12

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F52.0

Interventions

Group 1: Internet-based cognitive behavioral therapy: Guided online self-help program consisting of six modules. The intervention is based on cognitive behavioral principles and includes psychoeducati

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Cisgender or transgender woman Meeting diagnostic criteria for hypoactive sexual desire dysfunction according to ICD-11 (HA00) Meeting diagnostic criteria for a depressive disorder according to ICD-11 (6A70, 6A71, 6A72, or 6A73) with mild, moderate, or severe severity or in partial remission Access to a computer or laptop with internet connection Sufficient German language skills (written and spoken)

Exclusion criteria

Exclusion criteria: Current substance use disorder Current or lifetime psychotic disorder or bipolar disorder Other severe mental comorbidity in the past two years that might make participation too burdensome Significant symptoms of sexual pain with vaginal penetration Significant relationship discord or intimate partner violence Current pregnancy and early postpartum (up to 6 weeks after birth) Acute suicidal ideation Current treatment for sexual dysfunctions (e.g., hormonal therapy, sexual therapy, couples counseling)

Design outcomes

Primary

Measure	Time frame
(1) Feasibility of recruitment: Number of included participants relative to target sample, assessed through continuous study monitoring throughout the recruitment period. (2) Adherence: (a) Proportion of participants providing complete post-treatment data, assessed via online questionnaire 10 weeks after inclusion; (b) Proportion of participants completing all six treatment modules, assessed through usage data from the intervention platform. (3) Treatment satisfaction: Satisfaction with the intervention, measured with the Client Satisfaction Questionnaire for Internet Interventions (CSQ-I), assessed via online questionnaire 10 weeks after inclusion. (4) Safety: (a) Number and type of adverse events and serious adverse events, assessed with the Negative Effects Questionnaire (NEQ), administered via online questionnaire 5 and 10 weeks after inclusion; (b) Change in depressive symptoms, measured with the Patient Health Questionnaire (PHQ-9), assessed via online questionnaire at baseline and 10 weeks after inclusion. (5) Preliminary efficacy: (a) Change in sexual desire, measured with the Sexual Interest and Desire Inventory-Female Self-Report (SIDI-F-SR), assessed via online questionnaire at baseline and 10 weeks after inclusion; (b) Change in sexual distress, measured with the Female Sexual Distress Scale-Revised (FSDS-R), assessed via online questionnaire at baseline and 10 weeks after inclusion. All feasibility criteria will be evaluated using a traffic light system (green/yellow/red) to guide decision-making about a larger confirmatory trial.	—

Measure

Time frame

(1) Feasibility of recruitment: Number of included participants relative to target sample, assessed through continuous study monitoring throughout the recruitment period. (2) Adherence: (a) Proportion of participants providing complete post-treatment data, assessed via online questionnaire 10 weeks after inclusion; (b) Proportion of participants completing all six treatment modules, assessed through usage data from the intervention platform. (3) Treatment satisfaction: Satisfaction with the intervention, measured with the Client Satisfaction Questionnaire for Internet Interventions (CSQ-I), assessed via online questionnaire 10 weeks after inclusion. (4) Safety: (a) Number and type of adverse events and serious adverse events, assessed with the Negative Effects Questionnaire (NEQ), administered via online questionnaire 5 and 10 weeks after inclusion; (b) Change in depressive symptoms, measured with the Patient Health Questionnaire (PHQ-9), assessed via online questionnaire at baseline and 10 weeks after inclusion. (5) Preliminary efficacy: (a) Change in sexual desire, measured with the Sexual Interest and Desire Inventory-Female Self-Report (SIDI-F-SR), assessed via online questionnaire at baseline and 10 weeks after inclusion; (b) Change in sexual distress, measured with the Female Sexual Distress Scale-Revised (FSDS-R), assessed via online questionnaire at baseline and 10 weeks after inclusion. All feasibility criteria will be evaluated using a traffic light system (green/yellow/red) to guide decision-making about a larger confirmatory trial.

—

Secondary

Measure	Time frame
Participants' subjectively perceived change in sexual complaints, measured with a modified version of the Clinical Global Impressions Scale – Improvement (CGI-I), assessed via online questionnaire 10 weeks after inclusion.	—

Countries

Germany

Contacts

Public ContactJulia Velten

Ruhr-Universität Bochum, Klinische Psychologie und Psychotherapie

julia.velten@rub.de+49 234 32 23169

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026