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NCT07692984
The Effect of Comorbid Alcohol/Substance Use
Conditions: Alcohol Abuse, Alcohol Use Disorder, Substance Use Disorders, Severe Mental Disorder, Schizophrenia, Bipolar Disorder, Ostracism
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Enrollment: 297
Sponsor: Abant Izzet Baysal University
Location: Melisa Bulut Bolu Bolu
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07692984). StuddyBuddy aggregates publicly available trial information.