SchizophreniaSECRETNCT05951660
Sex, Psychopharmacology, and Diabetes
A study testing Educational intervention in people with Schizophrenia and Schizophrenia Spectrum and Other Psychotic Disorders, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Diabetes Mellitus
- What is being tested?
- Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Aug 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Incapacitated or subject to mental health probation
- Unable to speak danish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Assertive Community Centres
Slagelse
Rikke Meyer, MD, +45-20419810
About this study
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.
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:
Read more
- 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
- Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Diabetes Mellitus, PreDiabetes, Sexual Dysfunction, Drug-Related Side Effects and Adverse Reactions
- Being tested
- Educational intervention
- Keywords
- Randomized Controlled Trial, Treatment Adherence and Compliance, Antipsychotic Agents, Patient Education as Topic
- Medical subject headings
- Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Diabetes Mellitus, Prediabetic State, Sexual Dysfunction, Physiological, Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| INT1: Only patients are educated | Experimental | Not described Receives: Behavioral: Educational intervention |
| INT2: Only Healthcare Professionals are educated | Experimental | Not described Receives: Behavioral: Educational intervention |
| INT3: Both patients and Healthcare Professionals are educated | Experimental | Not described Receives: Behavioral: Educational intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to follow up in the total score of Changes in Sexual Function Questionnaire-14 (CSFQ-14)
Measured by Changes in Sexual Function Questionnaire-14 (CSFQ-14)
Measured: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.
Secondary outcomes (4)
Changes in psycho-pharmacological treatment
Estimated by changes in prescribed medications
Measured: 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
The number of systematic examinations of sexual side effects estimated by the number of consultations where sexual side effects are addressed, and whether it is the patient or the healthcare professional, who addresses the subject.
Measured: 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
Measured by Rating of Medication Influences (ROMI) Scale
Measured: 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
Measured by Shared Decision Making-9 (SDM) measurement tool
Measured: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start24 Aug 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Steno Diabetes Center Sjaelland, University College Copenhagen
- Responsible party
- Sponsor
- Investigators
- Gesche Jürgens, Clinical Professor, Study chair, Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, DenmarkAnnamaria Giraldi, Clinical Professor, Principal investigator, Sexological Clinic, Psychiatric Centre Copenhagen, DenmarkLise Tarnow, MD, DMSc, Principal investigator, Steno Diabetes Center Sjaelland, DenmarkCharlotte Bredahl Jacobsen, Senior Researcher, PhD., Principal investigator, Institute of Social Work, University College Copenhagen, Copenhagen, DenmarkRikke Meyer, MD, Principal investigator, Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951660
- Sponsor's protocol ID
- EMN-2022-08015, SJ-1005
- Acronym
- SECRET
- Status last verified
- Feb 2025
- First submitted
- 10 Jul 2023
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05951660
- Acronym / sponsor ID
- SECRET / EMN-2022-08015, SJ-1005
- Conditions
- Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Diabetes Mellitus, PreDiabetes, Sexual Dysfunction, Drug-Related Side Effects and Adverse Reactions
- Keywords
- Randomized Controlled Trial, Treatment Adherence and Compliance, Antipsychotic Agents, Patient Education as Topic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Steno Diabetes Center Sjaelland, University College Copenhagen
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| INT1: Only patients are educated | Experimental | Behavioral: Educational intervention |
| INT2: Only Healthcare Professionals are educated | Experimental | Behavioral: Educational intervention |
| INT3: Both patients and Healthcare Professionals are educated | Experimental | Behavioral: Educational intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- A diagnosis in the schizophrenic spectrum (ICD10 F2x)
- One of the following:
- Ongoing treatment with at least one antipsychotic agent
- A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14)
Key exclusion criteria (2 listed)
- Incapacitated or subject to mental health probation
- Unable to speak danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventionDifferent 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. | Behavioural | INT1: Only patients are educated, INT2: Only Healthcare Professionals are educated, INT3: Both patients and Healthcare Professionals are educated |
Primary outcome
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.
Measured by Changes in Sexual Function Questionnaire-14 (CSFQ-14)
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gesche Jürgens, Clinical Professor study chair
Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
Annamaria Giraldi, Clinical Professor principal investigator
Sexological Clinic, Psychiatric Centre Copenhagen, Denmark
Lise Tarnow, MD, DMSc principal investigator
Steno Diabetes Center Sjaelland, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Schizophrenia and Schizophrenia Spectrum and Other Psychotic Disorders, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gesche Jürgens, Clinical Professor (+45-93566501, gju@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.