Melisa Bulut
Bolu, 141000, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07692984
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Bolu, 141000, Turkey (Türkiye)
Location status: Recruiting
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
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)
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
Contact information is provided by the study sponsor or research team.
Abant Izzet Baysal University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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