Psychosocial Factors in Dual Diagnosis in a General Hospital
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Virgen del Puerto
About this trial
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.
The 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.
Sociodemographic, 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years).
Hospitalized patients with a clinical diagnosis of dual diagnosis.
Ability to provide informed consent.
Disqualifiers
Severe cognitive impairment or acute clinical condition preventing assessment.
Refusal or inability to provide informed consent.
Trial population
Adult inpatients hospitalized in a general hospital with a clinical diagnosis of dual diagnosis.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
125 Participants
are grouped into 1 trial groupGroup A: Hospitalized Patients With Dual Diagnosis
Trial outcomes
Primary outcomes
1
Medication adherence measured by Simplified Medication Adherence Questionnaire (SMAQ)
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.
Time frame
Baseline (within 72 hours of hospital admission)Secondary outcomes
1
Observed treatment adherence during hospitalization (clinical proxy index 0-3)
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.
Time frame
At hospital discharge (average length of stay approximately 10-14 days)2
Clinical severity measured by Clinical Global Impression - Severity scale (CGI-S)
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.
Time frame
Baseline (within 72 hours of hospital admission)3
Health-related quality of life measured by EuroQol-5D-5L index score
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.
Time frame
Baseline (within 72 hours of hospital admission)4
Self-rated health status measured by EQ-5D Visual Analog Scale (VAS)
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.
Time frame
Baseline (within 72 hours of hospital admission)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov