Effect of Cognitive Behavioral Therapy on Auditory Hallucinations and NLR in Schizophrenia Patients

NCT07524868 | Completed

• 2 other identifiers: CBT-SCZ-NLR-2026UNHAS-PSY-2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia Patients; Auditory Hallucination

Keywords

Cognitive Behavioral Therapy; Schizophrenia; Auditory Hallucinations; Neutrophil to Lymphocyte Ratio; Inflammation; Risperidone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in neutrophil-to-lymphocyte ratio (NLR)

  Baseline to 10 weeks

Study Arms (2)

CBT + Pharmacotherapy

EXPERIMENTAL

Participants receive cognitive behavioral therapy (CBT) in addition to standard pharmacological treatment (risperidone).

Behavioral: Cognitive Behavioral Therapy (CBT); Drug: risperidone

Pharmacotherapy Only

ACTIVE COMPARATOR

Participants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy.

Drug: risperidone

Interventions

risperidone DRUG

Participants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy.

Also known as: risperdal, Antipsychotic

CBT + Pharmacotherapy; Pharmacotherapy Only

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.

Also known as: CBT, Cognitive Therapy

CBT + Pharmacotherapy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Presence of severe medical or neurological illness
• Substance use disorder (excluding nicotine)
• Severe cognitive impairment or inability to participate in interviews
• Patients with acute agitation or requiring emergency intervention
• Currently receiving structured psychotherapy other than CBT

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Regional Special Hospital (RSKD) Dadi, South Sulawesi, Indonesia

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Hallucinations; Schizophrenia; Inflammation

Interventions

Cognitive Behavioral Therapy; Risperidone; Antipsychotic Agents

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Psychiatrist

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: November 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)