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Cognitive Behavioral Therapy Added to Risperidone for Schizophrenia

NCT07609953 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-27

No results posted yet for this study

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

Interventions

DRUG

Risperidone 4 to 6 mg/day

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

BEHAVIORAL

Cognitive Behavioral Therapy

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.

Sponsors & Collaborators

  • Hasanuddin University

    lead OTHER

Principal Investigators

  • Maya Angela Lisal, Medical Doctor · Hasanuddin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • Indonesia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07609953 on ClinicalTrials.gov