NCT07443033

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

February 18, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

February 18, 2026

Last Update Submit

February 24, 2026

Conditions

Dual DiagnosisSubstance Use DisorderMental Disorders

Keywords

Addiction psychiatryMental healthCross-sectional studyObservational studyHospitalized patientsFunctional outcomesClinical outcomesProtective factorsPsychosocial factorsDual diagnosis

Outcome Measures

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.

    Baseline (within 72 hours of hospital admission)

Secondary Outcomes (5)

  • Observed treatment adherence during hospitalization (clinical proxy index 0-3)

    At hospital discharge (average length of stay approximately 10-14 days)

  • Clinical severity measured by Clinical Global Impression - Severity scale (CGI-S)

    Baseline (within 72 hours of hospital admission)

  • Health-related quality of life measured by EuroQol-5D-5L index score

    Baseline (within 72 hours of hospital admission)

  • Self-rated health status measured by EQ-5D Visual Analog Scale (VAS)

    Baseline (within 72 hours of hospital admission)

  • Suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS)

    Baseline (within 72 hours of hospital admission)

Study Arms (1)

Hospitalized Patients With Dual Diagnosis

Adult inpatients diagnosed with dual diagnosis hospitalized in a general hospital.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Virgen del Puerto

Plasencia, Caceres, 10600, Spain

Location

MeSH Terms

Conditions

Substance-Related DisordersMental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersPersonal SatisfactionBehavior

Study Officials

  • María Josefa Lorenzo Bragado, MD

    Hospital Virgen del Puerto

    STUDY CHAIR

Central Study Contacts

Guillermo F Martínez Montás, MD

CONTACT

+34689617510guillermof.martinez@salud-juntaex.es

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2026

First Posted

March 2, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant confidentiality and in accordance with local ethics committee approval and institutional data protection regulations.

Locations

ES(1)