Supportive Psychotherapy As An Adjunct To Risperidone Improves Cognitive Function And Reduces High-Sensitivity C-Reactive Protein (Hs-CRP) In Schizophrenia: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function (MoCA-Ina Score)
研究概览
简要总结
This study examined whether adding structured supportive psychotherapy to risperidone treatment is more effective than risperidone alone in improving cognitive function and reducing inflammation in patients with schizophrenia.
Forty-six male patients with schizophrenia were randomly assigned to two groups: the intervention group (n=23) received risperidone 4 mg/day plus 12 sessions of structured supportive psychotherapy over 6 weeks. The control group (n=23) received risperidone 4 mg/day alone for 6 weeks.
Cognitive function was measured using the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina) and inflammation was measured using serum high-sensitivity C-reactive protein (hs-CRP) levels, both assessed at baseline (Week 0) and after treatment (Week 6).
NOTE: This trial was retrospectively registered. The study was conducted from December 2024 to February 2025 and received ethical clearance (No. 1009/UN4.6.4.5.31/PP36/2024) from the Biomedical Research Ethics Committee, Faculty of Medicine, Universitas Hasanuddin, prior to study initiation. Registration was performed after study completion due to the investigator's initial unawareness of prospective registration requirements. No outcome measures, study design, or statistical analysis plan were modified following data collection.
详细描述
This double-blind randomized controlled trial was conducted at Dadi Psychiatric Hospital (RSJ Dadi), South Sulawesi Province, Makassar, Indonesia, from December 2024 to February 2025.
BACKGROUND:
Schizophrenia is associated with cognitive impairment and elevated inflammatory markers, including high-sensitivity C-reactive protein (hs-CRP). Supportive psychotherapy has been proposed as an adjunctive intervention to pharmacotherapy to address these deficits. However, evidence on the combined effect of supportive psychotherapy and risperidone on both cognitive function and inflammation remains limited.
INTERVENTION:
The intervention group received risperidone 4 mg/day (2 mg twice daily) plus structured supportive psychotherapy consisting of 12 sessions delivered twice weekly over 6 weeks (15-30 minutes per session). The control group received risperidone 4 mg/day monotherapy for 6 weeks. To minimize expectation bias, supportive psychotherapy was described to all participants as "standard supportive counseling," thereby preventing identification of group allocation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participant blinding was achieved by describing the intervention to all participants as "standard supportive counseling," thereby preventing identification of group allocation and minimizing expectation bias. The structured supportive psychotherapy module used in the intervention group was not disclosed to participants. Outcomes assessors who evaluated MoCA-Ina scores and laboratory personnel who measured serum hs-CRP levels were fully blinded to participants' allocation status throughout the study period.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients diagnosed with schizophrenia according to DSM-5 criteria
- •Aged 20-45 years
- •Disease onset less than one year
- •Insight level grade 4
- •PANSS-EC score 14 or less
- •Total PANSS score 60-70
- •No febrile conditions, jaundice, or hepatosplenomegaly
- •Willing and able to attend supportive psychotherapy sessions
- •Receiving risperidone at fixed dose of 4 mg per day
- •South Sulawesi ethnic origin
排除标准
- •Organic comorbid diseases
- •History of substance abuse within previous six months except caffeine and nicotine
- •Comorbid personality disorders
- •Active infectious diseases
- •Use of anti-inflammatory agents, antibiotics, or antioxidant supplements
- •Female sex
研究组 & 干预措施
Supportive Psychotherapy plus Risperidone
Participants received risperidone 4 mg/day (2 mg tablet twice daily, oral administration) plus structured supportive psychotherapy consisting of 12 sessions delivered twice weekly over 6 weeks (15-30 minutes per session). Supportive psychotherapy was delivered using a validated module by the principal investigator.
干预措施: Structured Supportive Psychotherapy (Behavioral)
Supportive Psychotherapy plus Risperidone
Participants received risperidone 4 mg/day (2 mg tablet twice daily, oral administration) plus structured supportive psychotherapy consisting of 12 sessions delivered twice weekly over 6 weeks (15-30 minutes per session). Supportive psychotherapy was delivered using a validated module by the principal investigator.
干预措施: Risperidone 2 mg (Drug)
Risperidone Monotherapy
Participants received risperidone 4 mg/day (2 mg tablet twice daily, oral administration) monotherapy for 6 weeks without any structured psychotherapy intervention.
干预措施: Risperidone 2 mg (Drug)
结局指标
主要结局
Change in Cognitive Function (MoCA-Ina Score)
时间窗: Baseline (Week 0) and post-intervention (Week 6)
Change in cognitive function assessed by the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina) from baseline to Week 6. Score range 0-30; higher scores indicate better cognitive function. Inter-rater reliability kappa=0.820.
Change in Serum hs-CRP Level
时间窗: Baseline (Week 0) and post-intervention (Week 6)
Change in serum high-sensitivity C-reactive protein (hs-CRP) level from baseline to Week 6, measured by Sandwich-ELISA (Elabscience Human hs-CRP ELISA Kit, Cat. No. E-EL-H5134; detection range 15.63-1000 pg/mL; sensitivity 9.38 pg/mL).
次要结局
- Correlation Between Delta hs-CRP and Delta MoCA-Ina(Week 6 (end of intervention))
研究者
Agus Durman
Principal Investigator
Hasanuddin University