Clinical trial NCT05951660: Sex, Psychopharmacology, and Diabetes
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
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Mental Health Services in the Capital Region, Denmark
name: Steno Diabetes Center Sjaelland
name: University College Copenhagen
First posted: 2023-07-19
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* 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:

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

Primary outcomes:
measure: Changes from baseline to follow up in the total score of Changes in Sexual Function Questionnaire-14 (CSFQ-14)
timeFrame: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.
Secondary outcomes:
measure: Changes in psycho-pharmacological treatment
timeFrame: 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.
measure: The frequency in which sexual issues are discussed in the clinical consultation
timeFrame: 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.
measure: Changes from baseline to follow up in compliance / Adherence to the Pharmacological Treatment
timeFrame: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.
measure: Changes from baseline to follow up in shared decision making
timeFrame: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Assertive Community Centres
Study officials:
affiliation: Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
name: Gesche Jürgens, Clinical Professor
role: STUDY_CHAIR
affiliation: Sexological Clinic, Psychiatric Centre Copenhagen, Denmark
name: Annamaria Giraldi, Clinical Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Steno Diabetes Center Sjaelland, Denmark
name: Lise Tarnow, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Social Work, University College Copenhagen, Copenhagen, Denmark
name: Charlotte Bredahl Jacobsen, Senior Researcher, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
name: Rikke Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: