Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT05951660
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2023-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sex, Psychopharmacology, and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-07-10', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': 'Measured by Changes in Sexual Function Questionnaire-14 (CSFQ-14)'}], 'secondaryOutcomes': [{'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.', 'description': 'Estimated by changes in prescribed medications'}, {'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.', 'description': '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.'}, {'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.', 'description': 'Measured by Rating of Medication Influences (ROMI) Scale'}, {'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.', 'description': 'Measured by Shared Decision Making-9 (SDM) measurement tool'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized Controlled Trial', 'Treatment Adherence and Compliance', 'Antipsychotic Agents', 'Patient Education as Topic'], 'conditions': ['Schizophrenia', 'Schizophrenia Spectrum and Other Psychotic Disorders', 'Diabetes Mellitus', 'PreDiabetes', 'Sexual Dysfunction', 'Drug-Related Side Effects and Adverse Reactions', 'Education']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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:\n\n* Increases the number of systematic examinations of sexual side effects,\n* Causes changes in the psycho-pharmacological treatment, and\n* Reduces the severity or perception of sexual side effects.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* A diagnosis in the schizophrenic spectrum (ICD10 F2x)\n* One of the following:\n\n 1. A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x)\n 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\n 3. Obesity defined as a Body-Mass Index (BMI) ≥30 kg/m2\n* Ongoing treatment with at least one antipsychotic agent\n* A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14)\n\nExclusion Criteria:\n\n* Incapacitated or subject to mental health probation\n* Unable to speak danish"}, 'identificationModule': {'nctId': 'NCT05951660', 'acronym': 'SECRET', 'briefTitle': 'Sex, Psychopharmacology, and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'The Effect of Targeted Education on Number, Severity, and Perception of Sexual Side Effects of Patients Suffering From Schizophrenia and Diabetes or Prediabetes.', 'orgStudyIdInfo': {'id': 'EMN-2022-08015, SJ-1005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INT1: Only patients are educated', 'interventionNames': ['Behavioral: Educational intervention']}, {'type': 'EXPERIMENTAL', 'label': 'INT2: Only Healthcare Professionals are educated', 'interventionNames': ['Behavioral: Educational intervention']}, {'type': 'EXPERIMENTAL', 'label': 'INT3: Both patients and Healthcare Professionals are educated', 'interventionNames': ['Behavioral: Educational intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Educational intervention', 'type': 'BEHAVIORAL', 'description': 'Different teaching sessions are used for patients and healthcare professionals, respectively.\n\nThe 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.\n\nThe topics of the teaching sessions are:\n\n* What is sexuality?\n* How psychopharmacology influences sexuality\n* What can be done?\n\nThe topics will be addressed in a mixture of short informative talks using a PowerPoint presentation, group discussions, and exchanges of personal experiences.', 'armGroupLabels': ['INT1: Only patients are educated', 'INT2: Only Healthcare Professionals are educated', 'INT3: Both patients and Healthcare Professionals are educated']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Slagelse', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Rikke Meyer, MD', 'role': 'CONTACT', 'phone': '+45-20419810'}], 'facility': 'Assertive Community Centres', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}], 'centralContacts': [{'name': 'Gesche Jürgens, Clinical Professor', 'role': 'CONTACT', 'email': 'gju@regionsjaelland.dk', 'phone': '+45-93566501'}, {'name': 'Rikke Meyer, MD', 'role': 'CONTACT', 'email': 'rikme@regionsjaelland.dk', 'phone': '+45-20419810'}], 'overallOfficials': [{'name': 'Gesche Jürgens, Clinical Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark'}, {'name': 'Annamaria Giraldi, Clinical Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sexological Clinic, Psychiatric Centre Copenhagen, Denmark'}, {'name': 'Lise Tarnow, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steno Diabetes Center Sjaelland, Denmark'}, {'name': 'Charlotte Bredahl Jacobsen, Senior Researcher, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Social Work, University College Copenhagen, Copenhagen, Denmark'}, {'name': 'Rikke Meyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mental Health Services in the Capital Region, Denmark', 'class': 'OTHER'}, {'name': 'Steno Diabetes Center Sjaelland', 'class': 'OTHER_GOV'}, {'name': 'University College Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}