Psychosocial Factors in Dual Diagnosis in a General Hospital (DUAL-HVP)

February 24, 2026 updated by: Hospital Virgen del Puerto

Psychosocial Protective Factors and Clinical-Functional Outcomes in Hospitalized Patients With Dual Diagnosis: An Observational, Cross-Sectional, Single-Center Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

This 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.

Data 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.

The 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.

This 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.

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult inpatients hospitalized in a general hospital with a clinical diagnosis of dual diagnosis.

Description

Inclusion Criteria:

  • Adults (≥18 years).
  • Hospitalized patients with a clinical diagnosis of dual diagnosis.
  • Ability to provide informed consent.

Exclusion Criteria:

  • Severe cognitive impairment or acute clinical condition preventing assessment.
  • Refusal or inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hospitalized Patients With Dual Diagnosis
Adult inpatients diagnosed with dual diagnosis hospitalized in a general hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence measured by Simplified Medication Adherence Questionnaire (SMAQ)
Time Frame: Baseline (within 72 hours of hospital admission)
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.
Baseline (within 72 hours of hospital admission)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observed treatment adherence during hospitalization (clinical proxy index 0-3)
Time Frame: At hospital discharge (average length of stay approximately 10-14 days)
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.
At hospital discharge (average length of stay approximately 10-14 days)
Clinical severity measured by Clinical Global Impression - Severity scale (CGI-S)
Time Frame: Baseline (within 72 hours of hospital admission)
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.
Baseline (within 72 hours of hospital admission)
Health-related quality of life measured by EuroQol-5D-5L index score
Time Frame: Baseline (within 72 hours of hospital admission)
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.
Baseline (within 72 hours of hospital admission)
Self-rated health status measured by EQ-5D Visual Analog Scale (VAS)
Time Frame: Baseline (within 72 hours of hospital admission)
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.
Baseline (within 72 hours of hospital admission)
Suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline (within 72 hours of hospital admission)
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.
Baseline (within 72 hours of hospital admission)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Virgen del Puerto

Investigators

  • Study Chair: María Josefa Lorenzo Bragado, MD, Hospital Virgen Del Puerto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUAL-HVP-OBS-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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