Effect of Cognitive Behavioral Therapy on Auditory Hallucinations and NLR in Schizophrenia Patients (CBT-SCZ-NLR)

April 14, 2026 updated by: Rinvil Renaldi, Hasanuddin University

Effectiveness of Cognitive Behavioral Therapy as an Adjunctive Treatment on Auditory Hallucinations and Neutrophil-to-Lymphocyte Ratio in Patients With Schizophrenia Receiving Risperidone

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 90245
        • Regional Special Hospital (RSKD) Dadi, South Sulawesi, Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT + Pharmacotherapy
Participants receive cognitive behavioral therapy (CBT) in addition to standard pharmacological treatment (risperidone).
Behavioral: Cognitive Behavioral Therapy (CBT)
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.
Other Names:
  • CBT
  • Cognitive Therapy
Drug: risperidone
Participants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy.
Other Names:
  • risperdal
  • Antipsychotic
Active Comparator: Pharmacotherapy Only
Participants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy.
Drug: risperidone
Participants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy.
Other Names:
  • risperdal
  • Antipsychotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in auditory hallucination severity (PSYRATS)
Time Frame: Baseline to 10 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in neutrophil-to-lymphocyte ratio (NLR)
Time Frame: Baseline to 10 weeks
Change in inflammatory status measured using the neutrophil-to-lymphocyte ratio (NLR). Higher values indicate greater systemic inflammation.
Baseline to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Actual)

January 31, 2026

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBT-SCZ-NLR-2026
  • UNHAS-PSY-2026 (Other Identifier: Hasanuddin University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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