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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07524868
Acronym
CBT-SCZ-NLR
Enrollment
50
Registered
2026-04-13
Start date
2025-11-01
Completion date
2026-01-31
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Hallucination, Schizophrenia Patients

Keywords

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

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.

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.

Interventions

BEHAVIORALCognitive 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.

DRUGrisperidone

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

Sponsors

Hasanuddin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in auditory hallucination severity (PSYRATS)Baseline to 10 weeksChange 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

MeasureTime frameDescription
Change in neutrophil-to-lymphocyte ratio (NLR)Baseline to 10 weeksChange in inflammatory status measured using the neutrophil-to-lymphocyte ratio (NLR). Higher values indicate greater systemic inflammation.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026