Education on sexual dysfunction for patients with schizophrenia 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.
This study tests whether providing education about sexual dysfunction can help adults with schizophrenia and diabetes feel better about their sexual health while they are on antipsychotic medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Slagelse) |
| Trial ID | NCT05951660 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of targeted education on sexual dysfunction (SD) for patients diagnosed with schizophrenia and diabetes or prediabetes. It aims to increase the systematic examination of sexual side effects, prompt changes in psycho-pharmacological treatment, and reduce the severity or perception of these side effects. The study employs a multicenter randomized controlled trial design to assess the effectiveness of this educational intervention. Participants will include adults currently receiving antipsychotic treatment and experiencing SD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of schizophrenia and either diabetes, prediabetes, or obesity, who are currently on antipsychotic medication and experiencing sexual dysfunction.
Not a fit: Patients who are incapacitated, under mental health probation, or unable to speak Danish will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and treatment adherence for patients suffering from sexual dysfunction related to schizophrenia and diabetes.
How similar studies have performed: While the approach of addressing sexual dysfunction in psychiatric patients is recognized, this specific educational intervention in the context of schizophrenia and diabetes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * A diagnosis in the schizophrenic spectrum (ICD10 F2x) * One of the following: 1. A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x) 2. A current or previous prediabetes defined as an HbA1c between 39-47 mmol/mol (both included) measured in at least two blood samples collected with ≥3 months intervals as part of the patient's routine clinical monitoring 3. Obesity defined as a Body-Mass Index (BMI) ≥30 kg/m2 * Ongoing treatment with at least one antipsychotic agent * A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14) Exclusion Criteria: * Incapacitated or subject to mental health probation * Unable to speak danish
Where this trial is running
Slagelse
- Assertive Community Centres — Slagelse, Denmark (Recruiting)
Study contacts
- Principal investigator: Annamaria Giraldi, Clinical Professor — Sexological Clinic, Psychiatric Centre Copenhagen, Denmark
- Study coordinator: Gesche Jürgens, Clinical Professor
- Email: gju@regionsjaelland.dk
- Phone: +45-93566501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.