Sex, Psychopharmacology, and Diabetes (SECRET)

Zealand University Hospital

Status: Enrolling

Conditions: Drug-Related Side Effects and Adverse Reactions; Education; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Diabetes Mellitus; Sexual Dysfunction; PreDiabetes

Treatments: Behavioral: Educational intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05951660

EMN-2022-08015, SJ-1005

Details and patient eligibility

About

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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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256 participants in 4 patient groups

INT1: Only patients are educated

Experimental group

Treatment:

Behavioral: Educational intervention

INT2: Only Healthcare Professionals are educated

Experimental group

Treatment:

Behavioral: Educational intervention

INT3: Both patients and Healthcare Professionals are educated

Experimental group

Treatment:

Behavioral: Educational intervention

Control

No Intervention group