Alcohol AbuseNCT07692984
The Effect of Comorbid Alcohol/Substance Use
An observational study of Alcohol Abuse and Alcohol Use Disorder, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Abuse, Alcohol Use Disorder, Substance Use Disorders
- What is being tested?
- case (comorbid diagnosis)
- How many people
- 297 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2026to 30 Dec 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals diagnosed with organic brain damage or neurodevelopmental disorders (intellectual disability, etc.),
- Individuals with severe cognitive impairment that prevents them from communicating adequately.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Melisa Bulut
Bolu, Bolu, 141000
Melisa Bulut, PhD, melisa.bulut@ibu.edu.tr
About this study
Official title: The Effect of Comorbid Alcohol/Substance Use on Social Inclusion and Clinical Outcome in Individuals With Severe Mental Illness Enrolled in a Community Mental Health Center: A Cross-Sectional Case-Control Study
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.
Read more
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.
Read the detailed description
Study Setting and Sample The study will be conducted at the Bolu İzzet Baysal Mental Health and Diseases Rehabilitation Center , which has a follow-up pool of approximately 1,300 active patients. The study population consists of these 1,300 individuals. The sample size was calculated using Cochran's formula with finite population correction, at a 95% confidence level and a 5% margin of error. This calculation yielded a minimum sample size of 297 individuals. Case and control groups will be distributed in an approximately 1:1 ratio (148 cases, 149 controls).
Data Collection Form
- Sociodemographic Variables Age, gender, marital status, education level, living arrangement (living with family/alone/in an institution, etc.), employment status (employed, unemployed, retired, or receiving a disability pension), and social security status.
- Clinical Variables Primary psychiatric diagnosis (per DSM-5: schizophrenia spectrum disorders or bipolar disorder) ASUD diagnosis and type of substance used (alcohol, cannabis, stimulants, etc.) Duration of illness (in years) Length of follow-up at the Rehabilitation and Treatment Center (in months) Number of psychiatric hospital admissions and total days of hospitalization over the past 2 years Calculated daily chlorpromazine-equivalent (CPZ-eq) dose of antipsychotic and mood-stabilizing medications used Treatment adherence, assessed based on prescription refill frequency and clinical follow-up notes Substance use will be assessed using the Drug Abuse Screening Test (DAST-10) and alcohol use using the Alcohol Use Disorders Identification Test (AUDIT)
- Social Inclusion and Rehabilitation Variables Attendance rate at TRSM workshops and rehabilitation programs (number of sessions attended / number of sessions planned) Indicators of social adjustment: employment status, independent living skills, and breadth of social network (relationships outside the family) Number of emergency department visits over the past 12 months Social Exclusion (Ostracism) Scale score
- Drug Abuse Screening Test (DAST-10) The DAST-10 is a 10-item self-report instrument developed to screen for problems related to the use of substances other than alcohol and tobacco. Developed by Harvey A. Skinner, it assesses substance-related problems over the past 12 months. Items are answered yes/no, with each "yes" scored as 1 point (item 3 is reverse-scored). Total scores range from 0 to 10, with higher scores indicating more severe substance use problems. A Turkish validity and reliability study found an internal consistency coefficient of Cronbach's α = 0.92. That study recommended a cutoff score of ≥4, yielding a sensitivity of 0.98 and specificity of 0.91. The scale is widely used to rapidly screen for substance use problems in clinical and research settings.
- Alcohol Use Disorders Identification Test (AUDIT) The AUDIT is a screening instrument developed to identify hazardous and harmful alcohol use. It was developed by Thomas F. Babor and colleagues as part of a multicenter study conducted by the World Health Organization (WHO). The AUDIT consists of 10 items assessing frequency of alcohol use, symptoms of dependence, and alcohol-related problems over the past 12 months. Items are scored on a 0-4 Likert-type scale, yielding a total score range of 0-40, with higher scores indicating more hazardous drinking. A Turkish validity and reliability study confirmed the Turkish version as a valid and reliable measurement tool; a cutoff score of 8 or above is generally accepted to indicate hazardous/harmful alcohol use. The AUDIT is widely used in clinical and research settings for rapid, effective screening of alcohol-related risk. The scale's total possible score is 40, with a cutoff of 8, and its reliability coefficient is 0.65.
- Social Exclusion (Ostracism) Scale This is a brief self-report scale developed to assess the frequency of social exclusion (ostracism) experiences in individuals' daily lives. Developed by Sandra C. Rudert and colleagues, it measures exclusion experiences over the preceding two months. The scale consists of 4 items with a unidimensional structure, rated on a 7-point Likert scale (1 = Never, 7 = Always). The total score is calculated by summing item scores, with higher scores indicating more frequent experiences of social exclusion. Confirmatory factor analysis supported a single-factor structure with good model fit (CFI = 0.99, RMSEA = 0.04), and internal consistency was high (Cronbach's α = .90), confirming the scale as a reliable measurement tool.
- Conditions
- Alcohol Abuse, Alcohol Use Disorder, Substance Use Disorders, Severe Mental Disorder, Schizophrenia, Bipolar Disorder
- Being tested
- case (comorbid diagnosis), control
- Keywords
- alcohol use disorder, Substance Use Disorders, Severe Mental Disorder, ostracism
- Medical subject headings
- Alcoholism, Substance-Related Disorders, Mental Disorders, Schizophrenia, Bipolar Disorder, Ostracism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
controlOther
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start20 Jun 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 297 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melisa BULUT, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692984
- Sponsor's protocol ID
- AIBU-PSK-MB-06
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Comorbid Alcohol/Substance Use on Social Inclusion and Clinical Outcome in Individuals With Severe Mental Illness Enrolled in a Community Mental Health Center: A Cross-Sectional Case-Control Study
- ClinicalTrials.gov ID
- NCT07692984
- Acronym / sponsor ID
- AIBU-PSK-MB-06
- Conditions
- Alcohol Abuse, Alcohol Use Disorder, Substance Use Disorders, Severe Mental Disorder, Schizophrenia, Bipolar Disorder
- Keywords
- alcohol use disorder, Substance Use Disorders, Severe Mental Disorder, ostracism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 297 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jul 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.
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.
Detailed description
Study Setting and Sample The study will be conducted at the Bolu İzzet Baysal Mental Health and Diseases Rehabilitation Center , which has a follow-up pool of approximately 1,300 active patients. The study population consists of these 1,300 individuals. The sample size was calculated using Cochran's formula with finite population correction, at a 95% confidence level and a 5% margin of error. This calculation yielded a minimum sample size of 297 individuals. Case and control groups will be distributed in an approximately 1:1 ratio (148 cases, 149 controls).
Data Collection Form
- Sociodemographic Variables Age, gender, marital status, education level, living arrangement (living with family/alone/in an institution, etc.), employment status (employed, unemployed, retired, or receiving a disability pension), and social security status.
- Clinical Variables Primary psychiatric diagnosis (per DSM-5: schizophrenia spectrum disorders or bipolar disorder) ASUD diagnosis and type of substance used (alcohol, cannabis, stimulants, etc.) Duration of illness (in years) Length of follow-up at the Rehabilitation and Treatment Center (in months) Number of psychiatric hospital admissions and total days of hospitalization over the past 2 years Calculated daily chlorpromazine-equivalent (CPZ-eq) dose of antipsychotic and mood-stabilizing medications used Treatment adherence, assessed based on prescription refill frequency and clinical follow-up notes Substance use will be assessed using the Drug Abuse Screening Test (DAST-10) and alcohol use using the Alcohol Use Disorders Identification Test (AUDIT)
- Social Inclusion and Rehabilitation Variables Attendance rate at TRSM workshops and rehabilitation programs (number of sessions attended / number of sessions planned) Indicators of social adjustment: employment status, independent living skills, and breadth of social network (relationships outside the family) Number of emergency department visits over the past 12 months Social Exclusion (Ostracism) Scale score
- Drug Abuse Screening Test (DAST-10) The DAST-10 is a 10-item self-report instrument developed to screen for problems related to the use of substances other than alcohol and tobacco. Developed by Harvey A. Skinner, it assesses substance-related problems over the past 12 months. Items are answered yes/no, with each "yes" scored as 1 point (item 3 is reverse-scored). Total scores range from 0 to 10, with higher scores indicating more severe substance use problems. A Turkish validity and reliability study found an internal consistency coefficient of Cronbach's α = 0.92. That study recommended a cutoff score of ≥4, yielding a sensitivity of 0.98 and specificity of 0.91. The scale is widely used to rapidly screen for substance use problems in clinical and research settings.
- Alcohol Use Disorders Identification Test (AUDIT) The AUDIT is a screening instrument developed to identify hazardous and harmful alcohol use. It was developed by Thomas F. Babor and colleagues as part of a multicenter study conducted by the World Health Organization (WHO). The AUDIT consists of 10 items assessing frequency of alcohol use, symptoms of dependence, and alcohol-related problems over the past 12 months. Items are scored on a 0-4 Likert-type scale, yielding a total score range of 0-40, with higher scores indicating more hazardous drinking. A Turkish validity and reliability study confirmed the Turkish version as a valid and reliable measurement tool; a cutoff score of 8 or above is generally accepted to indicate hazardous/harmful alcohol use. The AUDIT is widely used in clinical and research settings for rapid, effective screening of alcohol-related risk. The scale's total possible score is 40, with a cutoff of 8, and its reliability coefficient is 0.65.
- Social Exclusion (Ostracism) Scale This is a brief self-report scale developed to assess the frequency of social exclusion (ostracism) experiences in individuals' daily lives. Developed by Sandra C. Rudert and colleagues, it measures exclusion experiences over the preceding two months. The scale consists of 4 items with a unidimensional structure, rated on a 7-point Likert scale (1 = Never, 7 = Always). The total score is calculated by summing item scores, with higher scores indicating more frequent experiences of social exclusion. Confirmatory factor analysis supported a single-factor structure with good model fit (CFI = 0.99, RMSEA = 0.04), and internal consistency was high (Cronbach's α = .90), confirming the scale as a reliable measurement tool.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: case (comorbid diagnosis)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) |
| Control group | – | Other: control(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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals diagnosed with organic brain damage or neurodevelopmental disorders (intellectual disability, etc.),
- Individuals with severe cognitive impairment that prevents them from communicating adequately.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Case group |
| controlSocial 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 | Other | Control group |
Primary outcome
Ostracism
Time frame: 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.
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 13 Jul 2026.
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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.
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 Alcohol Abuse and Alcohol Use Disorder, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 13 Jul 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 Turkey (Türkiye). 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 Melisa Bulut, PhD (+905348855882, melisa.bulut@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ostracism (time frame: Baseline). 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 13 Jul 2026.