Actively Recruiting
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
Eligibility Criteria
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)
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
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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