Sex, Psychopharmacology, and Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational intervention.
- Who it may be relevant to
- Registry conditions: Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Diabetes Mellitus, PreDiabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Targeted Education on Number, Severity, and Perception of Sexual Side Effects of Patients Suffering From Schizophrenia and Diabetes or Prediabetes.
Overview
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.
Interventions
- Behavioral Educational 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
Primary outcome measures
- Changes from baseline to follow up in the total score of Changes in Sexual Function Questionnaire-14 (CSFQ-14) [Time frame: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.]
Secondary outcome measures (4)
- Changes in psycho-pharmacological treatment [Time frame: Recorded continuously throughout the entire study period, i.e. from the day of the educational intervention to 6 months after the end of the educational intervention.]
- The frequency in which sexual issues are discussed in the clinical consultation [Time frame: Recorded continuously throughout the entire study period, i.e. from the day of the educational intervention to 6 months after the end of the educational intervention.]
- Changes from baseline to follow up in compliance / Adherence to the Pharmacological Treatment [Time frame: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.]
- Changes from baseline to follow up in shared decision making [Time frame: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- A diagnosis in the schizophrenic spectrum (ICD10 F2x)
- One of the following:
- A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x)
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Denmark · 1 center
- Assertive Community Centres — Slagelse
Identifiers
NCT: NCT05951660 · EMN-2022-08015, SJ-1005