Dual DiagnosisDUAL-HVPNCT07443033
Psychosocial Factors in Dual Diagnosis in a General Hospital
An observational study of Dual Diagnosis and Substance Use Disorder, run by Hospital Virgen del Puerto at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dual Diagnosis, Substance Use Disorder, Mental Disorders
- How many people
- 125 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2026to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult inpatients hospitalized in a general hospital with a clinical diagnosis of dual diagnosis.
Who may be able to join
- Adults (≥18 years).
- Hospitalized patients with a clinical diagnosis of dual diagnosis.
- Ability to provide informed consent.
Who cannot join
- Severe cognitive impairment or acute clinical condition preventing assessment.
- Refusal or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Virgen del Puerto
Plasencia, Caceres, 10600
Guillermo F Martínez Montás, MD, 927428300, guillermof.martinez@salud-juntaex.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Dual Diagnosis, Substance Use Disorder, Mental Disorders
- Keywords
- Addiction psychiatry, Mental health, Cross-sectional study, Observational study, Hospitalized patients, Functional outcomes, Clinical outcomes, Protective factors, Psychosocial factors, Dual diagnosis
- Medical subject headings
- Substance-Related Disorders, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Patients With Dual Diagnosis | Adult inpatients diagnosed with dual diagnosis hospitalized in a general hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (within 72 hours of hospital admission)
Secondary outcomes (5)
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.
Measured: At hospital discharge (average length of stay approximately 10-14 days)
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.
Measured: Baseline (within 72 hours of hospital admission)
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.
Measured: Baseline (within 72 hours of hospital admission)
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.
Measured: Baseline (within 72 hours of hospital admission)
Suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Measured: Baseline (within 72 hours of hospital admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Mar 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Virgen del Puerto
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- María Josefa Lorenzo Bragado, MD, Study chair, Hospital Virgen del Puerto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443033
- Sponsor's protocol ID
- DUAL-HVP-OBS-2026
- Acronym
- DUAL-HVP
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and in accordance with local ethics committee approval and institutional data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Protective Factors and Clinical-Functional Outcomes in Hospitalized Patients With Dual Diagnosis: An Observational, Cross-Sectional, Single-Center Study
- ClinicalTrials.gov ID
- NCT07443033
- Acronym / sponsor ID
- DUAL-HVP / DUAL-HVP-OBS-2026
- Conditions
- Dual Diagnosis, Substance Use Disorder, Mental Disorders
- Keywords
- Addiction psychiatry, Mental health, Cross-sectional study, Observational study, Hospitalized patients, Functional outcomes, Clinical outcomes, Protective factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Hospital Virgen del PuertoOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Patients With Dual Diagnosis | – | –Adult inpatients diagnosed with dual diagnosis hospitalized in a general hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult inpatients hospitalized in a general hospital with a clinical diagnosis of dual diagnosis.
Key inclusion criteria (3 listed)
- Adults (≥18 years).
- Hospitalized patients with a clinical diagnosis of dual diagnosis.
- Ability to provide informed consent.
Key exclusion criteria (2 listed)
- Severe cognitive impairment or acute clinical condition preventing assessment.
- Refusal or inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Observed treatment adherence during hospitalization (clinical proxy index 0-3)
Time frame: 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)
Health-related quality of life measured by EuroQol-5D-5L index score
Time frame: 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)
Suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline (within 72 hours of hospital admission)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality and in accordance with local ethics committee approval and institutional data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María Josefa Lorenzo Bragado, MD study chair
Hospital Virgen del Puerto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dual Diagnosis and Substance Use Disorder, run by Hospital Virgen del Puerto at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo F Martínez Montás, MD (+34689617510, guillermof.martinez@salud-juntaex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence measured by Simplified Medication Adherence Questionnaire (SMAQ) (time frame: Baseline (within 72 hours of hospital admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.