Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
256 participants
INTERVENTIONAL
2023-08-24
2025-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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INT1: Only patients are educated
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 for the dialogue on SD and drug-related side effects.
The topics of the teaching sessions are:
* What is sexuality?
* How psychopharmacology influences sexuality
* What can be done?
The topics will be addressed in a mixture of short informative talks using a PowerPoint presentation, group discussions, and exchanges of personal experiences.
INT2: Only Healthcare Professionals are educated
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 for the dialogue on SD and drug-related side effects.
The topics of the teaching sessions are:
* What is sexuality?
* How psychopharmacology influences sexuality
* What can be done?
The topics will be addressed in a mixture of short informative talks using a PowerPoint presentation, group discussions, and exchanges of personal experiences.
INT3: Both patients and Healthcare Professionals are educated
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 for the dialogue on SD and drug-related side effects.
The topics of the teaching sessions are:
* What is sexuality?
* How psychopharmacology influences sexuality
* What can be done?
The topics will be addressed in a mixture of short informative talks using a PowerPoint presentation, group discussions, and exchanges of personal experiences.
Control
No interventions assigned to this group
Interventions
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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 for the dialogue on SD and drug-related side effects.
The topics of the teaching sessions are:
* What is sexuality?
* How psychopharmacology influences sexuality
* What can be done?
The topics will be addressed in a mixture of short informative talks using a PowerPoint presentation, group discussions, and exchanges of personal experiences.
Eligibility Criteria
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Inclusion Criteria
* 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
* Unable to speak danish
18 Years
ALL
No
Sponsors
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Mental Health Services in the Capital Region, Denmark
OTHER
Steno Diabetes Center Sjaelland
OTHER_GOV
University College Copenhagen
OTHER
Zealand University Hospital
OTHER
Responsible Party
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Principal Investigators
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Gesche Jürgens, Clinical Professor
Role: STUDY_CHAIR
Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
Annamaria Giraldi, Clinical Professor
Role: PRINCIPAL_INVESTIGATOR
Sexological Clinic, Psychiatric Centre Copenhagen, Denmark
Lise Tarnow, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Sjaelland, Denmark
Charlotte Bredahl Jacobsen, Senior Researcher, PhD.
Role: PRINCIPAL_INVESTIGATOR
Institute of Social Work, University College Copenhagen, Copenhagen, Denmark
Rikke Meyer, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
Locations
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Assertive Community Centres
Slagelse, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Rikke Meyer, MD
Role: primary
Other Identifiers
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EMN-2022-08015, SJ-1005
Identifier Type: -
Identifier Source: org_study_id
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