Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05951660

Sex, Psychopharmacology, and Diabetes

Led by Zealand University Hospital · Updated on 2025-02-11

256

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

Sponsors

Z

Zealand University Hospital

Lead Sponsor

M

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Sex, Psychopharmacology, and Diabetes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 18 years
  • Diagnosis within the schizophrenic spectrum (ICD10 F2x)
  • Diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x), or current/previous prediabetes defined by HbA1c between 39-47 mmol/mol measured at least twice over 3 months apart, or obesity with BMI 65 30 kg/m2
  • Ongoing treatment with at least one antipsychotic agent
  • Sexual dysfunction that can be assessed using the Changes in Sexual Function Questionnaire-14 (CSFQ-14)
Not Eligible

You will not qualify if you...

  • Incapacitated or under mental health probation
  • Unable to speak Danish

AI-Screening

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Trial Site Locations

Total: 1 location

1

Assertive Community Centres

Slagelse, Denmark

Actively Recruiting

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Research Team

G

Gesche Jürgens, Clinical Professor

CONTACT

R

Rikke Meyer, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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