Sex, Psychopharmacology, and Diabetes

The term sexual (SD) dysfunction covers conditions that prevent people from having a satisfactory sex life. SD is a frequent and sometimes debilitating complication of mental illness and a known adverse reaction to psycho-pharmacological treatment. SD is also associated with diabetes, a common somatic comorbidity in psychiatric patients. SD is associated with both reduced quality-of-life and reduced treatment adherence, yet SD is far too rarely addressed between the patient and the healthcare professional in clinical consultations. The purpose of the study is to investigate whether targeted education of patients with schizophrenia and diabetes/prediabetes and/or their healthcare professionals in causes and management of SD: * Increases the number of systematic examinations of sexual side effects, * Causes changes in the psycho-pharmacological treatment, and * Reduces the severity or perception of sexual side effects. The study is a multicenter Randomized Controlled Trial (RCT) with four arms, in which the educational intervention is provided to patients, healthcare professionals, or both groups. The effect of the educational intervention is compared to a non-educated control group. The study is expected to include 192 patients recruited from 16 assertive community treatment centers evenly distributed in four Danish regions. The study is part of an interdisciplinary project named SECRET. The educational intervention was developed in an ethnographic pre-study incorporating stakeholder engagement. Parallel to the present RCT, an ethnographic field study will be carried out to broaden the perspective on the effects of the intervention.

NCT Number	NCT05951660
Lead Sponsor	Zealand University Hospital Collaborators: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Steno Diabetes Center Sjaelland, University College Copenhagen
Conditions	Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Diabetes Mellitus, PreDiabetes, Sexual Dysfunction, Drug-Related Side Effects and Adverse Reactions, Education
Enrollment	256 participants
Start Date	2023-08-24
Primary Completion	2025-07-31 (estimated)
Study Completion	2025-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-11