Sex, Psychopharmacology, and Diabetes

NCT05951660 | Recruiting

• 1 other identifier: EMN-2022-08015, SJ-1005
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

  At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (4)

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

Interventions

Educational intervention BEHAVIORAL

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.

INT1: Only patients are educated; INT2: Only Healthcare Professionals are educated; INT3: Both patients and Healthcare Professionals are educated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Incapacitated or subject to mental health probation
• Unable to speak danish

Sponsors & Collaborators

• Zealand University Hospital: lead
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator
• Steno Diabetes Center Sjaelland: collaborator
• University College Copenhagen: collaborator

Study Sites (1)

Assertive Community Centres

Slagelse, Denmark

RECRUITING

MeSH Terms

Conditions

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

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Genital Diseases; Urogenital Diseases; Chemically-Induced Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Gesche Jürgens, Clinical Professor

  Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gesche Jürgens, Clinical Professor

CONTACT

+45-93566501; gju@regionsjaelland.dk

Rikke Meyer, MD

CONTACT

+45-20419810; rikme@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 19, 2023
• Study Start: August 24, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)