Effectiveness of Cognitive Behavioral Therapy as an Adjunctive Treatment on Auditory Hallucinations and Neutrophil-to-Lymphocyte Ratio in Patients With Schizophrenia Receiving Risperidone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in auditory hallucination severity (PSYRATS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CBT + Pharmacotherapy
Participants receive cognitive behavioral therapy (CBT) in addition to standard pharmacological treatment (risperidone).
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
CBT + Pharmacotherapy
Participants receive cognitive behavioral therapy (CBT) in addition to standard pharmacological treatment (risperidone).
干预措施: risperidone (Drug)
Pharmacotherapy Only
Participants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy.
干预措施: risperidone (Drug)
结局指标
主要结局
Change in auditory hallucination severity (PSYRATS)
时间窗: 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
次要结局
- Change in neutrophil-to-lymphocyte ratio (NLR)(Baseline to 10 weeks)
研究者
Rinvil Renaldi
MD, Psychiatrist
Hasanuddin University