NCT07524868Completed
Effect of Cognitive Behavioral Therapy on Auditory Hallucinations and NLR in Schizophrenia Patients
Effectiveness of Cognitive Behavioral Therapy as an Adjunctive Treatment on Auditory Hallucinations and Neutrophil-to-Lymphocyte Ratio in Patients With Schizophrenia Receiving Risperidone
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
This study aims to evaluate the effectiveness of Cognitive Behavioral Therapy (CBT) as an adjunctive treatment to pharmacotherapy in reducing auditory hallucinations and inflammation, as measured by the neutrophil-to-lymphocyte ratio (NLR), in patients with schizophrenia. Schizophrenia is a chronic psychiatric disorder characterized by positive symptoms, including auditory hallucinations, which significantly impair functioning and quality of life. While antipsychotic medications such as risperidone are effective in managing symptoms, a substantial proportion of patients continue to experience persistent hallucinations. Cognitive Behavioral Therapy (CBT) has been shown to improve coping strategies and reduce distress associated with hallucinations. Recent evidence suggests that inflammation plays a role in the pathophysiology of schizophrenia. The neutrophil-to-lymphocyte ratio (NLR) is a simple and accessible biomarker of systemic inflammation and has been associated with symptom severity in schizophrenia. However, limited studies have explored whether psychological interventions such as CBT can influence inflammatory markers. This study uses a quasi-experimental design involving two groups: an intervention group receiving CBT in addition to standard pharmacotherapy, and a control group receiving pharmacotherapy alone. CBT will be delivered in structured sessions focusing on cognitive restructuring, behavioral modification, and coping strategies for auditory hallucinations. Clinical outcomes will be assessed using the Psychotic Symptom Rating Scales (PSYRATS) for auditory hallucinations, while inflammatory status will be measured using NLR obtained from peripheral blood samples. Assessments will be conducted before and after the intervention period. The findings of this study are expected to provide evidence on the effectiveness of CBT not only in improving clinical symptoms but also in potentially modulating inflammatory processes in patients with schizophrenia.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 6 Apr 2026
- Start date
- 1 Nov 2025
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Hasanuddin University
- Diseases
- Schizophrenia
- NCT number
- NCT07524868
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 1 Nov 2025 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving structured psychotherapy other than CBT
Other illness
- Presence of severe medical or neurological illness
- Substance use disorder (excluding nicotine)
- Severe cognitive impairment or inability to participate in interviews
Other
- Patients with acute agitation or requiring emergency intervention
Who the study is looking for
- Patients diagnosed with schizophrenia based on clinical assessment
- Age 18-60 years
- Experiencing auditory hallucinations
- Currently receiving antipsychotic treatment (e.g., risperidone)
- Able to communicate and participate in Cognitive Behavioral Therapy (CBT)
- Willing to provide informed consent
Age in the registry: 20 years to 50 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regional Special Hospital (RSKD) Dadi, South Sulawesi, Indonesia Coordinator of this site? Confirm its status | Makassar | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.