Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:08 AM
Study NCT ID:
NCT07443033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychosocial Factors in Dual Diagnosis in a General Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication adherence measured by Simplified Medication Adherence Questionnaire (SMAQ)', 'timeFrame': 'Baseline (within 72 hours of hospital admission)', 'description': 'Medication adherence assessed using the 6-item Simplified Medication Adherence Questionnaire (SMAQ). Participants will be classified as adherent or non-adherent according to the original scoring criteria.'}], 'secondaryOutcomes': [{'measure': 'Observed treatment adherence during hospitalization (clinical proxy index 0-3)', 'timeFrame': 'At hospital discharge (average length of stay approximately 10-14 days)', 'description': 'Treatment adherence during hospital stay assessed using a structured clinical proxy index derived from medical records. The index ranges from 0 to 3 (0 = ≤33% adherence; 1 = 34-66%; 2 = 67-89%; 3 = ≥90%), based on medication compliance and participation in therapeutic activities.'}, {'measure': 'Clinical severity measured by Clinical Global Impression - Severity scale (CGI-S)', 'timeFrame': 'Baseline (within 72 hours of hospital admission)', 'description': 'Global clinical severity assessed by the treating psychiatrist using the 7-point Clinical Global Impression - Severity scale (1 = normal, 7 = extremely ill). Higher scores indicate greater illness severity.'}, {'measure': 'Health-related quality of life measured by EuroQol-5D-5L index score', 'timeFrame': 'Baseline (within 72 hours of hospital admission)', 'description': 'Health-related quality of life assessed using the EQ-5D-5L descriptive system. The utility index score (range depends on national value set; typically \\<0 to 1, where 1 indicates full health) will be calculated according to the Spanish value set.'}, {'measure': 'Self-rated health status measured by EQ-5D Visual Analog Scale (VAS)', 'timeFrame': 'Baseline (within 72 hours of hospital admission)', 'description': 'Self-reported health status measured on a 0-100 visual analog scale, where 0 represents the worst imaginable health state and 100 the best imaginable health state.'}, {'measure': 'Suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline (within 72 hours of hospital admission)', 'description': 'Presence of suicidal ideation assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). Participants will be categorized as having any suicidal ideation (yes/no) during the assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Addiction psychiatry', 'Mental health', 'Cross-sectional study', 'Observational study', 'Hospitalized patients', 'Functional outcomes', 'Clinical outcomes', 'Protective factors', 'Psychosocial factors', 'Dual diagnosis'], 'conditions': ['Dual Diagnosis', 'Substance Use Disorder', 'Mental Disorders']}, 'descriptionModule': {'briefSummary': 'Dual diagnosis, defined as the co-occurrence of a mental disorder and a substance use disorder, is frequently associated with increased clinical severity, functional impairment, and poorer health outcomes. Identifying psychosocial protective factors related to better clinical and functional outcomes is essential to improve patient care and treatment planning.\n\nThe aim of this observational, cross-sectional, single-center study is to analyze psychosocial protective factors and their association with clinical-functional outcomes in hospitalized patients with dual diagnosis. The study will be conducted in a general hospital setting and will include adult inpatients diagnosed with dual diagnosis according to clinical criteria.\n\nSociodemographic, clinical, and psychosocial variables will be collected using standardized assessment tools and clinical records. The results of this study are expected to contribute to a better understanding of psychosocial factors associated with clinical severity and functional outcomes in patients with dual diagnosis, supporting more comprehensive and patient-centered care approaches.', 'detailedDescription': 'Dual diagnosis, characterized by the coexistence of a mental disorder and a substance use disorder, represents a major clinical challenge in mental health services. Patients with dual diagnosis frequently present greater clinical complexity, higher rates of hospitalization, functional impairment, and difficulties in treatment adherence. Beyond clinical variables, psychosocial factors may play a relevant role as protective elements influencing clinical and functional outcomes.\n\nThis study is designed as an observational, cross-sectional, single-center study conducted in a general hospital. The study population will consist of adult patients hospitalized with a clinical diagnosis of dual diagnosis. Participants will be recruited during their hospital admission according to predefined inclusion and exclusion criteria.\n\nData collection will include sociodemographic information, clinical variables related to psychiatric and substance use disorders, and psychosocial factors considered potentially protective. Clinical-functional outcomes will be assessed using standardized instruments and information obtained from medical records. All data will be collected as part of routine clinical assessment, without introducing any experimental intervention.\n\nThe primary objective of the study is to evaluate the association between psychosocial protective factors and clinical-functional outcomes in hospitalized patients with dual diagnosis. Secondary objectives include describing the sociodemographic and clinical characteristics of the study population and exploring the relationship between psychosocial variables and indicators of clinical severity.\n\nThis study does not involve the administration of investigational drugs or devices and does not modify standard clinical practice. The research protocol has been reviewed and approved by the corresponding Ethics Committee. The findings are expected to provide relevant information to support a biopsychosocial approach in the assessment and management of patients with dual diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult inpatients hospitalized in a general hospital with a clinical diagnosis of dual diagnosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥18 years).\n* Hospitalized patients with a clinical diagnosis of dual diagnosis.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment or acute clinical condition preventing assessment.\n* Refusal or inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07443033', 'acronym': 'DUAL-HVP', 'briefTitle': 'Psychosocial Factors in Dual Diagnosis in a General Hospital', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Virgen del Puerto'}, 'officialTitle': 'Psychosocial Protective Factors and Clinical-Functional Outcomes in Hospitalized Patients With Dual Diagnosis: An Observational, Cross-Sectional, Single-Center Study', 'orgStudyIdInfo': {'id': 'DUAL-HVP-OBS-2026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospitalized Patients With Dual Diagnosis', 'description': 'Adult inpatients diagnosed with dual diagnosis hospitalized in a general hospital.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10600', 'city': 'Plasencia', 'state': 'Caceres', 'country': 'Spain', 'contacts': [{'name': 'Guillermo F Martínez Montás, MD', 'role': 'CONTACT', 'email': 'guillermof.martinez@salud-juntaex.es', 'phone': '927428300'}], 'facility': 'Hospital Virgen del Puerto', 'geoPoint': {'lat': 40.03116, 'lon': -6.08845}}], 'centralContacts': [{'name': 'Guillermo F Martínez Montás, MD', 'role': 'CONTACT', 'email': 'guillermof.martinez@salud-juntaex.es', 'phone': '+34689617510'}], 'overallOfficials': [{'name': 'María Josefa Lorenzo Bragado, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Virgen del Puerto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared to protect participant confidentiality and in accordance with local ethics committee approval and institutional data protection regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Virgen del Puerto', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}