NCT05951660: SECRET

Sex, Psychopharmacology, and Diabetes

Recruiting now NA Last updated 11 February 2025

What this trial tests

NA trial testing Educational intervention in Schizophrenia in 256 participants. Currently enrolling.

Timeline

24 August 2023

Primary endpoint
31 July 2025

31 July 2025

Quick facts

Lead sponsor	Zealand University Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	256
Start date	24 August 2023
Primary completion	31 July 2025
Estimated completion	31 July 2025
Sites	1 location across Denmark

Drugs / interventions tested

• Educational intervention

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizophrenia Spectrum and Other Psychotic Disorders — all drugs for Schizophrenia Spectrum and Other Psychotic Disorders →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• PreDiabetes — all drugs for PreDiabetes →

Sponsor

Zealand University Hospital

Who can join

18 and older, any sex, with Schizophrenia or Schizophrenia Spectrum and Other Psychotic Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Steps to construct educational interventions on sexual dysfunction for healthcare professionals and patients. Experiences from the SECRET research study-group.
   Meyer R, Kotnis SR, Fog-Petersen CMØ, Tarnow L, et al · · 2024 · PMID 39035236 · DOI 10.1016/j.pecinn.2024.100310