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Completed

NCT Number: NCT07524868

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

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.

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Key information

Conditions

Schizophrenia Patients Auditory Hallucination Hallucinations Inflammation Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Makassar, South Sulawesi, 90245, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CBT, Cognitive Therapy

Risperidone

Drug

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

Other names: risperdal, Antipsychotic

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Official study title

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

Acronym: CBT-SCZ-NLR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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