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Sex, Psychopharmacology, and Diabetes (SECRET)

Primary Purpose

Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Randomized Controlled Trial, Treatment Adherence and Compliance, Antipsychotic Agents, Patient Education as Topic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years A diagnosis in the schizophrenic spectrum (ICD10 F2x) A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x) or prediabetes defined as an HbA1c between 39-47 mmol/mol (both included) measured in at least two blood samples collected with ≥3 months interval as part of the patients routine clinical monitoring Ongoing treatment with at least one antipsychotic agent Complaints about SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14) Exclusion Criteria: • Incapacitated or subject to mental health probation

Sites / Locations

  • Assertive Community CentresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

INT1: Only patients are educated

INT2: Only Healthcare Professionals are educated

INT3: Both patients and Healthcare Professionals are educated

Control

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Changes in psycho-pharmacological treatment
Estimated by changes in prescribed medications
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.
Changes from baseline to follow up in compliance / Adherence to the Pharmacological Treatment
Measured by Rating of Medication Influences (ROMI) Scale
Changes from baseline to follow up in shared decision making
Measured by Shared Decision Making-9 (SDM) measurement tool

Full Information

First Posted
July 10, 2023
Last Updated
September 20, 2023
Sponsor
Zealand University Hospital
Collaborators
Mental Health Services in the Capital Region, Denmark, Steno Diabetes Center Sjaelland, University College Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05951660
Brief Title
Sex, Psychopharmacology, and Diabetes
Acronym
SECRET
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
Collaborators
Mental Health Services in the Capital Region, Denmark, Steno Diabetes Center Sjaelland, University College Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Diabetes Mellitus, PreDiabetes, Sexual Dysfunction, Drug-Related Side Effects and Adverse Reactions, Education
Keywords
Randomized Controlled Trial, Treatment Adherence and Compliance, Antipsychotic Agents, Patient Education as Topic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INT1: Only patients are educated
Arm Type
Experimental
Arm Title
INT2: Only Healthcare Professionals are educated
Arm Type
Experimental
Arm Title
INT3: Both patients and Healthcare Professionals are educated
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline to follow up in the total score of Changes in Sexual Function Questionnaire-14 (CSFQ-14)
Description
Measured by 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 Measure Information:
Title
Changes in psycho-pharmacological treatment
Description
Estimated by changes in prescribed medications
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.
Title
The frequency in which sexual issues are discussed in the clinical consultation
Description
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.
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.
Title
Changes from baseline to follow up in compliance / Adherence to the Pharmacological Treatment
Description
Measured by Rating of Medication Influences (ROMI) Scale
Time Frame
At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.
Title
Changes from baseline to follow up in shared decision making
Description
Measured by Shared Decision Making-9 (SDM) measurement tool
Time Frame
At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years A diagnosis in the schizophrenic spectrum (ICD10 F2x) A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x) or prediabetes defined as an HbA1c between 39-47 mmol/mol (both included) measured in at least two blood samples collected with ≥3 months interval as part of the patients routine clinical monitoring Ongoing treatment with at least one antipsychotic agent Complaints about SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14) Exclusion Criteria: • Incapacitated or subject to mental health probation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gesche Jürgens, Clinical Professor
Phone
+45-93566501
Email
gju@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Rikke Meyer, MD
Phone
+45-20419810
Email
rikme@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gesche Jürgens, Clinical Professor
Organizational Affiliation
Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Annamaria Giraldi, Clinical Professor
Organizational Affiliation
Sexological Clinic, Psychiatric Centre Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lise Tarnow, MD, DMSc
Organizational Affiliation
Steno Diabetes Center Sjaelland, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charlotte Bredahl Jacobsen, Senior Researcher, PhD.
Organizational Affiliation
Institute of Social Work, University College Copenhagen, Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rikke Meyer, MD
Organizational Affiliation
Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assertive Community Centres
City
Slagelse
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rikke Meyer, MD
Phone
+45-20419810

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sex, Psychopharmacology, and Diabetes

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