Cognitive Behavioral Therapy Added to Risperidone for Schizophrenia (CBT-BDNF-SCZ)
Effectiveness of Cognitive Behavioral Therapy as Adjunctive Therapy on Cognitive Function and Serum Brain-Derived Neurotrophic Factor Levels in Patients With Schizophrenia Receiving Risperidone Therapy
This study evaluated whether cognitive behavioral therapy (CBT), when added to risperidone treatment, improves cognitive function and serum brain-derived neurotrophic factor (BDNF) levels in patients with schizophrenia. Participants were adults with stable-phase schizophrenia who were receiving risperidone therapy. They were assigned to either a control group receiving risperidone alone or an intervention group receiving risperidone plus 10 weekly CBT sessions.
Cognitive function was assessed using the Indonesian version of the Cognitive Assessment Interview (CAI-Ina). Serum BDNF levels were measured from blood samples using an enzyme-linked immunosorbent assay (ELISA). Measurements were performed at baseline and after 10 weeks. The study was conducted at Rumah Sakit Khusus Daerah Dadi, South Sulawesi, Indonesia.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Schizophrenia is a chronic psychiatric disorder associated not only with psychotic symptoms but also with persistent cognitive impairment. Cognitive deficits may affect attention, working memory, verbal memory, processing speed, reasoning, problem solving, and social cognition. These impairments can interfere with daily functioning and long-term recovery. Although risperidone is commonly used as an antipsychotic treatment for schizophrenia, its effect on cognitive function may be limited. Cognitive behavioral therapy (CBT) may provide additional benefit by helping patients identify maladaptive beliefs, develop coping strategies, improve insight, and strengthen adaptive behavior.
This study was designed to evaluate the effect of CBT as an adjunctive therapy to risperidone on cognitive function and serum BDNF levels in patients with schizophrenia. BDNF is a neurotrophic factor involved in neuroplasticity, synaptic function, learning, and memory. Lower BDNF levels have been associated with cognitive impairment in schizophrenia. The study assessed whether adding CBT to risperidone therapy was associated with improvement in cognitive function and changes in serum BDNF levels.
This was an interventional, randomized, single-blind, rater-blind study. Participants were patients with stable-phase schizophrenia treated at Rumah Sakit Khusus Daerah Dadi, South Sulawesi, Indonesia. Eligible participants were adults aged 20 to 50 years with schizophrenia diagnosed according to DSM-5 and PPDGJ-III criteria, illness onset of 5 years or less, stable clinical condition, and ongoing risperidone therapy.
Participants were assigned to two groups. The control group received risperidone therapy. The intervention group received risperidone therapy plus CBT. The CBT intervention consisted of 10 sessions delivered once weekly over 10 weeks, with each session lasting approximately 30 minutes. The CBT sessions included engagement and assessment of target problems, cognitive formulation, exploration of appraisals, evaluation of beliefs, gentle reality testing, development of alternative explanations, behavioral experiments, coping strategy enhancement, insight building, relapse prevention, and future planning.
Cognitive function was measured using the Indonesian version of the Cognitive Assessment Interview (CAI-Ina), an interview-based instrument for assessing cognitive function in patients with schizophrenia. Serum BDNF levels were measured from peripheral blood samples using ELISA. Assessments were performed at baseline and at week 10. The main objective was to compare changes in cognitive function and serum BDNF levels between the risperidone-only group and the risperidone plus CBT group.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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South Sulawesi
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Makassar, South Sulawesi, Indonésia, 90113
- Rumah Sakit Khusus Daerah (RSKD) Dadi Provinsi Sulawesi Selatan
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Patients diagnosed with schizophrenia according to DSM-5 and PPDGJ-III criteria.
- Illness onset of schizophrenia ≤ 5 years since the first appearance of symptoms.
- Age 20 to 50 years.
- Clinically stable phase, defined as PANSS score 30 to 60.
- Receiving risperidone therapy at a dose of 4 to 6 mg/day.
- Minimum educational level of senior high school.
- Willing to participate in the study and sign informed consent.
Exclusion Criteria:
- Presence of organic comorbid conditions, such as neurological disorders, severe endocrine or metabolic disorders, chronic liver or kidney disease, or systemic infection, that may affect cognitive function or serum BDNF levels.
- History of substance use before hospital admission, except caffeine and nicotine.
- Use of anti-inflammatory drugs, antibiotics, or antioxidant medications.
- Intellectual disability or mental retardation.
- Unwilling to attend cognitive behavioral therapy sessions.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Control Group
Participants received risperidone therapy without cognitive behavioral therapy.
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Risperidone was administered as antipsychotic therapy for patients with schizophrenia.
Participants in both study groups received risperidone therapy according to the study protocol.
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Experimental: Intervention Group
Participants received risperidone therapy plus 10 weekly sessions of cognitive behavioral therapy over 10 weeks.
Each CBT session lasted approximately 30 minutes.
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Risperidone was administered as antipsychotic therapy for patients with schizophrenia.
Participants in both study groups received risperidone therapy according to the study protocol.
Cognitive behavioral therapy was delivered as an adjunctive intervention to risperidone therapy.
The intervention consisted of 10 weekly sessions over 10 weeks, with each session lasting approximately 30 minutes.
Sessions included engagement, cognitive formulation, appraisal exploration, belief evaluation, gentle reality testing, alternative explanations, behavioral experiments, coping strategy enhancement, insight building, relapse prevention, and future planning.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Cognitive Function Assessed by CAI-Ina Total Score
Prazo: Baseline and week 10
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Cognitive function was assessed using the Indonesian version of the Cognitive Assessment Interview (CAI-Ina).
The CAI-Ina evaluates cognitive function in patients with schizophrenia, including processing speed, attention, working memory, verbal memory, reasoning and problem solving, and social cognition.
Higher scores indicate greater cognitive impairment.
The outcome was the change in total CAI-Ina score from baseline to week 10.
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Baseline and week 10
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Serum Brain-Derived Neurotrophic Factor Level
Prazo: Baseline and week 10
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Serum brain-derived neurotrophic factor (BDNF) level was measured from peripheral blood samples using enzyme-linked immunosorbent assay (ELISA).
The outcome was the change in serum BDNF level from baseline to week 10.
Values were reported in pg/mL.
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Baseline and week 10
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maya Angela Lisal, Medical Doctor, Hasanuddin University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UH25090757
- 807/UN4.6.4.5.31/PP36/2025 (Outro identificador: Hasanuddin University Research Ethics Committee)
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