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

Schizophrenia is a chronic psychiatric disorder characterized by positive symptoms such as auditory hallucinations. Despite pharmacological treatment with antipsychotics, many patients continue to experience persistent hallucinations and psychological distress. Cognitive Behavioral Therapy (CBT) has been shown to be effective as an adjunctive treatment to reduce the severity and distress associated with hallucinations. This study aims to evaluate the effectiveness of Cognitive Behavioral Therapy as an adjunctive treatment to risperidone in reducing auditory hallucination symptoms and neutrophil-to-lymphocyte ratio (NLR) as a marker of inflammation in patients with schizophrenia. This quasi-experimental study involves two groups: a control group receiving standard pharmacological treatment and an intervention group receiving CBT in addition to pharmacological treatment. Outcomes will be measured using the Psychotic Symptom Rating Scales (PSYRATS) and laboratory examination of NLR before and after the intervention. The results of this study are expected to provide evidence for the role of CBT not only in improving clinical symptoms but also in modulating biological markers associated 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) from baseline to post-intervention.

  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 according to DSM-5 and PPDGJ-III criteria.
• Male patients aged 20-50 years. Duration of illness (onset) less than 5 years. Patients in the non-acute (stabilized) phase, defined as a PANSS-EC score \< 15 (Montoya et al., 2011; Pompili et al., 2021).
• Presence of auditory hallucinations, indicated by a PANSS hallucination item score ≥ 4.
• Able and willing to participate in Cognitive Behavioral Therapy (CBT) sessions. Currently receiving risperidone at a dose of 2-4 mg/day. Minimum educational level of high school or equivalent.

You may not qualify if:

• Presence of comorbid organic medical conditions. History of substance use (NAPZA) prior to hospital admission, excluding caffeine and nicotine.
• Unwilling or unable to participate in CBT sessions.

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 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)