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Recruiting Observational

The Effect of Comorbid Alcohol/Substance Use

NCT07692984 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-06-20
Last updated
2026-07-13

Condition(s) studied

Alcohol AbuseAlcohol Use DisorderSubstance Use DisordersSevere Mental DisorderSchizophreniaBipolar DisorderOstracism

Investigational drug(s) / intervention(s)

case (comorbid diagnosis)control

case (comorbid diagnosis): Patients who already have a comorbid diagnosis of Alcohol and Substance Use Disorder (ASUD) have been exposed to alcohol and substances. Data will be collected by administering the scales to these patients. Social Inclusion and Rehabilitation Variables Substance Use Risk Screening Test (DAST-10) Screening Test for the Diagnosis of Alcohol Use Disorders (AUDIT) Social Exclusion (Ostracism) Scale

control: Social Inclusion and Rehabilitation Variables Substance Use Risk Screening Test (DAST-10) Screening Test for the Diagnosis of Alcohol Use Disorders (AUDIT) Social Exclusion (Ostracism) Scale

Study summary

Study Design This study was designed as a comparative, cross-sectional case-control study examining the effect of comorbid alcohol and substance use disorder (ASUD) on clinical course and social inclusion among individuals with severe mental illness followed at a Community Mental Health Center (CMHC). The study did not involve any interventions.

Aim The aim of this study is to examine the effect of comorbid alcohol and substance use on clinical course parameters-such as number of hospitalizations and medication dosages-and on social inclusion indicators-such as employment, social participation, and social adjustment-among individuals with severe mental illness followed at the CMHC, in comparison with a matched control group without substance use.

Research Questions

What are the rates of comorbid alcohol and substance use among patients with severe mental illness followed at the CMHC? What are the current addiction symptoms, number of hospitalizations, and employment rates among individuals with severe mental illness and comorbid ASUD? What is the level of continuity of CMHC engagement and social participation among individuals with severe mental illness and comorbid ASUD, and what factors influence it? How does the level of social inclusion among individuals with severe mental illness and comorbid ASUD compare with that of individuals without ASUD?

Hypotheses

H1: The average annual number of hospitalizations among individuals with a dual diagnosis (severe mental illness + ASUD) followed at the CMHC is significantly higher than among those without substance use.

H2: Among individuals with a dual diagnosis, the daily medication doses (e.g., chlorpromazine equivalents) required to control psychotic or manic symptoms are higher than in the control group.

H3: Social inclusion is lower among patients with substance use compared with the control group.

H4: Employment rates among individuals with a dual diagnosis are significantly lower than among those with severe mental illness alone.

H5: Substance use negatively affects patients' social participation, including involvement in activities and friendships.

H6: Attendance rates at CMHC workshops and rehabilitation programs are lower among individuals with substance use compared with the control group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Being 18 years of age or older, * Having a diagnosis of Schizophrenia Spectrum Disorder and Other Psychotic Disorders or Bipolar Disorder according to DSM-5 diagnostic criteria, * Being actively followed up at the TRSM for at least 6 months. Exclusion Criteria: * Individuals diagnosed with organic brain damage or neurodevelopmental disorders (intellectual disability, etc.), * Individuals with severe cognitive impairment that prevents them from communicating adequately.

Primary outcome measure(s)

  • Ostracism — Baseline
    The level of ostracism will be compared in case and control groups. The effect of alcohol and substance use disorder on the level of ostracism will also be examined.Ostracism will be measured using the "Social Exclusion Scale." The scale is a self-report scale consisting of four items. The minimum score on the scale is 4, and the maximum is 28 points. The total score obtained from the scale will be calculated by summing the items, and higher scores will indicate that the individual experiences social exclusion more frequently. This will show whether the case group or the control group experiences higher levels of ostracism.

Trial sites (1)

FacilityCityRegionStatus
Melisa Bulut Bolu Bolu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07692984 on ClinicalTrials.gov ↗ ← All trials in Turkey