Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05951660

The Effect of Targeted Education on Sexual Side Effects in Patients With Schizophrenia and Diabetes or Prediabetes

Led by Zealand University Hospital · Updated on 2025-02-11

256

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

Z

Zealand University Hospital

Lead Sponsor

M

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Sexual dysfunction includes conditions that prevent a satisfying sex life and is common among people with mental illnesses, particularly those treated with psychiatric medications. It is also linked to diabetes, a frequent health issue in psychiatric patients. This research evaluates whether targeted education for patients with schizophrenia and diabetes or prediabetes and their healthcare providers can improve how sexual side effects are managed, change medication use, and reduce the severity or perception of these side effects. The study is a multicenter randomized controlled trial comparing educational interventions given to patients, healthcare professionals, or both versus a group receiving no education. The educational sessions are held at Assertive Community Treatment Centers and last three 30-minute sessions for patients and one 60-minute session for healthcare professionals. These sessions, led by specialists in clinical pharmacology, psychiatry, and clinical sexology, cover sexuality basics, how psychopharmacology affects sexuality, and possible management strategies. The study has four groups: patient education only, healthcare professional education only, both groups educated, and a control group with no intervention. Participants will be assessed at the start and six months after the education using the Changes in Sexual Function Questionnaire-14. Researchers will monitor changes in medication use, how often sexual side effects are discussed during clinical visits, treatment adherence, and shared decision-making throughout the study. The total participation period includes the educational intervention and a six-month follow-up to evaluate lasting effects on sexual dysfunction and treatment management.

CONDITIONS

Brief Title

Sex, Psychopharmacology, and Diabetes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis in the schizophrenia spectrum (ICD10 F2x)
  • Diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, E14x), or current/previous prediabetes with HbA1c between 39-47 mmol/mol measured at least twice over 3 months, or obesity with BMI 30 kg/m2 or higher
  • Ongoing treatment with at least one antipsychotic agent
  • Sexual dysfunction that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14)
Not Eligible

You will not qualify if you...

  • Incapacitated or under mental health probation
  • Unable to speak Danish

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Single session

Participants receive targeted educational sessions about sexual side effects related to psychopharmacology. Sessions for patients last three 30-minute segments with breaks and are held at Assertive Community Treatment Centers. Healthcare professionals also receive a 60-minute teaching session. The education includes informative talks, group discussions, and personal experience exchanges to improve knowledge and communication about sexual dysfunction and drug side effects.

1 visit (in-person)

Long-term Monitoring

Duration - 6 months

After the educational intervention, participants are monitored for changes in sexual function, psychopharmacological treatment, compliance, and shared decision making over a six-month period.

Follow-up assessments at baseline and at 6 months

Trial Site Locations

Total: 1 location

1

Assertive Community Centres

Slagelse, Denmark

Actively Recruiting

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Research Team

G

Gesche Jürgens, Clinical Professor

R

Rikke Meyer, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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