SECRET: Sex and Psychopharmacology

Sponsor

Zealand University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05951660

Collaborator

Mental Health Services in the Capital Region, Denmark (Other), Steno Diabetes Center Sjaelland (Other), University College Copenhagen (Other)

192

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Diabetes Mellitus PreDiabetes Sexual Dysfunction Drug-Related Side Effects and Adverse Reactions Education	Behavioral: Educational intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

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.

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INT1: Only patients are educated	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 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.
Experimental: INT2: Only Healthcare Professionals are educated	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 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.
Experimental: INT3: Both patients and Healthcare Professionals are educated	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 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.
No Intervention: Control

Outcome Measures

Primary Outcome Measures

Changes from baseline to follow up in the total score of Changes in Sexual Function Questionnaire-14 (CSFQ-14) [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)

Secondary Outcome Measures

Changes in psycho-pharmacological treatment [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.]
Estimated by changes in prescribed medications
The frequency in which sexual issues are discussed in the clinical consultation [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 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 [At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.]
Measured by Rating of Medication Influences (ROMI) Scale
Changes from baseline to follow up in shared decision making [At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.]
Measured by Shared Decision Making-9 (SDM) measurement tool

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Zealand University Hospital
Mental Health Services in the Capital Region, Denmark
Steno Diabetes Center Sjaelland
University College Copenhagen

Investigators

Study Chair: Gesche Jürgens, Associate Professor, MD, PhD., Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
Principal Investigator: Annamaria Giraldi, Clinical Professor, Sexological Clinic, Psychiatric Centre Copenhagen, Denmark
Principal Investigator: Lise Tarnow, MD, DMSc, Steno Diabetes Center Sjaelland, Denmark
Principal Investigator: Charlotte Bredahl Jacobsen, Senior Researcher, PhD., Institute of Social Work, University College Copenhagen, Copenhagen, Denmark
Principal Investigator: Rikke Meyer, MD, Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark