NCT05951660

Sex, Psychopharmacology, and Diabetes

The Effect of Targeted Education on Number, Severity, and Perception of Sexual Side Effects of Patients Suffering From Schizophrenia and Diabetes or Prediabetes.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders
• Diabetes Mellitus
• PreDiabetes
• Sexual Dysfunction
• Drug-Related Side Effects and Adverse Reactions
• Education

Interventions

Type	Name	Description
BEHAVIORAL	Educational intervention	Different teaching sessions are used for patients and healthcare professionals, respectively. The teaching sessions are held at the Assertive Community Treatment (ACT) Centers from which the patients are recruited. The duration is 3x30 minutes with breaks for patients and 60 minutes for healthcare professionals. Teaching sessions are held by two doctors a specialist in clinical pharmacology and a specialist in psychiatry and clinical sexology providing the participants with knowledge and tools for the dialogue on SD and drug-related side effects. The topics of the teaching sessions are: * What is sexuality? * How psychopharmacology influences sexuality * What can be done? The topics will be addressed in a mixture of short informative talks using a PowerPoint presentation, group discussions, and exchanges of personal experiences.

Timeline

• Start date: 2023-08-24
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2023-07-19
• Last updated: 2025-02-11

Locations

1 site across 1 country: Denmark