Cognitive Behavioral Therapy Added to Risperidone for Schizophrenia

NCT07609953 | Completed

• 2 other identifiers: UH25090757807/UN4.6.4.5.31/PP36/2025
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

Cognitive Behavioral Therapy; CBT; Risperidone; Brain-Derived Neurotrophic Factor; BDNF; Cognitive Function; Cognitive Assessment Interview; CAI-Ina; Psychosis

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Function Assessed by CAI-Ina Total Score

  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.

  Baseline and week 10

Secondary Outcomes (1)

• Change in Serum Brain-Derived Neurotrophic Factor Level

  Baseline and week 10

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants received risperidone therapy without cognitive behavioral therapy.

Drug: Risperidone 4 to 6 mg/day

Intervention Group

EXPERIMENTAL

Participants received risperidone therapy plus 10 weekly sessions of cognitive behavioral therapy over 10 weeks. Each CBT session lasted approximately 30 minutes.

Drug: Risperidone 4 to 6 mg/day; Behavioral: Cognitive Behavioral Therapy

Interventions

Risperidone 4 to 6 mg/day DRUG

Risperidone was administered as antipsychotic therapy for patients with schizophrenia. Participants in both study groups received risperidone therapy according to the study protocol.

Control Group; Intervention Group

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT

Intervention Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Rumah Sakit Khusus Daerah (RSKD) Dadi Provinsi Sulawesi Selatan

Makassar, South Sulawesi, 90113, Indonesia

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maya Angela Lisal, Medical Doctor

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor/rater was blinded to participant group allocation. Participants and care providers were not masked because the CBT intervention could not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned to one of two parallel groups: risperidone therapy alone or risperidone therapy plus 10 weekly sessions of cognitive behavioral therapy.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: November 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)