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| ID | Type | Description | Link |
|---|---|---|---|
| UNHAS-PSY-2026 | Other Identifier | Hasanuddin University |
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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.
Schizophrenia is associated with both neurobiological and psychosocial dysfunctions, including persistent auditory hallucinations and systemic inflammation. The neutrophil-to-lymphocyte ratio (NLR) has emerged as a potential biomarker reflecting inflammatory processes in schizophrenia.
Cognitive Behavioral Therapy (CBT) is an evidence-based psychological intervention that helps patients modify maladaptive beliefs and reduce distress related to psychotic symptoms. However, its potential impact on biological markers such as NLR remains underexplored.
This study employs a quasi-experimental design with a pre-test and post-test control group. Participants diagnosed with schizophrenia and experiencing auditory hallucinations are divided into two groups: one receiving standard pharmacological treatment with risperidone, and the other receiving adjunctive CBT.
The primary outcomes include changes in auditory hallucination severity measured by PSYRATS and changes in NLR levels. The study aims to explore the integration of psychological and biological perspectives in schizophrenia treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT + Pharmacotherapy | Experimental | Participants receive cognitive behavioral therapy (CBT) in addition to standard pharmacological treatment (risperidone). |
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| Pharmacotherapy Only | Active Comparator | Participants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Behavioral | Cognitive behavioral therapy (CBT) will be provided in structured sessions focusing on identifying and modifying maladaptive thoughts and beliefs related to auditory hallucinations. Therapy will be delivered in multiple sessions over the study period by trained therapists. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in auditory hallucination severity (PSYRATS) | Change in auditory hallucination severity measured using the Psychotic Symptom Rating Scales (PSYRATS) - Auditory Hallucination Subscale. The total score ranges from 0 to 44, with higher scores indicating more severe symptoms | Baseline to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neutrophil-to-lymphocyte ratio (NLR) | Change in inflammatory status measured using the neutrophil-to-lymphocyte ratio (NLR). Higher values indicate greater systemic inflammation. | Baseline to 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Special Hospital (RSKD) Dadi, South Sulawesi, Indonesia | Makassar | South Sulawesi | 90245 | Indonesia |
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| ID | Term |
|---|---|
| D006212 | Hallucinations |
| D012559 | Schizophrenia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D018967 | Risperidone |
| D014150 | Antipsychotic Agents |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011744 | Pyrimidinones |
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Participants will be randomly assigned into two parallel groups: an intervention group receiving cognitive behavioral therapy (CBT) in addition to standard pharmacological treatment, and a control group receiving standard pharmacological treatment alone. Outcome measures, including clinical symptoms and inflammatory markers, will be assessed at baseline and after the intervention period.
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Outcome assessors are blinded to group allocation to reduce assessment bias, while participants and care providers are not blinded due to the nature of the intervention.
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| risperidone | Drug | Participants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy. |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014149 | Tranquilizing Agents |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D011619 | Psychotropic Drugs |