The Effect of Comorbid Alcohol/Substance Use

NCT07692984 | Recruiting

• 1 other identifier: AIBU-PSK-MB-06
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Abuse; Schizophrenia; Bipolar Disorder; Ostracism; Severe Mental Disorder; Alcohol Use Disorder; Substance Use Disorders

Keywords

alcohol use disorder; Substance Use Disorders; Severe Mental Disorder; ostracism

Outcome Measures

Primary Outcomes (1)

• Ostracism

  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.

  Baseline

Study Arms (2)

Case group

Patients will be divided into two groups based on whether or not they have a concomitant diagnosis of Alcohol and Substance Use Disorder (ASUD): (1) Dual diagnosis group (Severe Mental Illness + Alcohol and Substance Use Disorder)

Other: case (comorbid diagnosis)

Control group

(2) Control group (Severe Mental Illness, no Alcohol and Substance Use Disorder). The diagnosis of Alcohol and Substance Use Disorder will be determined according to DSM-5 criteria and the recorded diagnosis in the interview and clinical follow-up notes in the community mental health center physician records.

Other: control

Interventions

case (comorbid diagnosis) OTHER

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

Case group

control OTHER

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 group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with alcohol and substance use disorders among individuals with severe mental illness who are being followed up at the Community Mental Health Center.

You may qualify if:

• 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.

You may not qualify if:

• Individuals diagnosed with organic brain damage or neurodevelopmental disorders (intellectual disability, etc.),
• Individuals with severe cognitive impairment that prevents them from communicating adequately.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Melisa Bulut

Bolu, Bolu, 141000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders; Mental Disorders; Schizophrenia; Bipolar Disorder; Ostracism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders; Social Isolation; Social Behavior; Behavior

Central Study Contacts

Melisa Bulut, PhD

CONTACT

+905348855882; melisa.bulut@ibu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 9, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

TU (1)