RecruitingNot ApplicableNCT05951660

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.


Sponsor

Zealand University Hospital

Enrollment

256 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the relationship between sex, the use of antipsychotic medications, and the development of diabetes or metabolic problems in people diagnosed with a schizophrenia-spectrum disorder. The goal is to understand how these factors interact, particularly regarding sexual side effects of medications. **You may be eligible if...** - You are 18 or older with a diagnosis in the schizophrenia spectrum - You have been diagnosed with diabetes, have borderline blood sugar levels (prediabetes based on HbA1c), or have a BMI of 30 or higher - You are currently taking at least one antipsychotic medication - You are experiencing a sexual dysfunction that can be assessed using a standard questionnaire (CSFQ-14) - You are able to speak Danish **You may NOT be eligible if...** - You are subject to compulsory mental health treatment or have been legally incapacitated - You are unable to communicate in Danish Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALEducational 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.


Locations(1)

Assertive Community Centres

Slagelse, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05951660


Related Trials