A Pilot Study of Adjunctive Structured Supportive Psychotherapy in Schizophrenia

This pilot randomized controlled trial examined whether adding structured supportive psychotherapy to risperidone treatment is more effective than risperidone alone in improving cognitive function and reducing peripheral inflammation in stabilized inpatients with schizophrenia. Forty-four male and female inpatients with schizophrenia were randomly assigned to two groups: the intervention group (n=22) received risperidone 4 mg/day plus 12 individual sessions of structured supportive psychotherapy (45-60 minutes per session, once weekly) over 12 weeks. The control group (n=22) received risperidone 4 mg/day plus 12 sessions of unstructured supportive conversation (attention-matched) over the same 12-week period. 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 12). NOTE: This pilot randomized controlled trial was retrospectively registered. The study was conducted from March 2025 to June 2025 and received ethical clearance (PROTOKOL-UH24100793) from Komite Etik Penelitian 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.

Inclusion Criteria: * Male and female inpatients diagnosed with schizophrenia according to DSM-5-TR criteria * Aged 20 to 45 years * In a post-acute stabilized residual phase * Total PANSS score between 60 and 70 * Receiving risperidone at a fixed dose of 4 mg per day * Willing and able to attend individual psychotherapy sessions throughout the 12-week trial period Exclusion Criteria: * Febrile conditions at time of screening * Organic comorbid diseases * Active infectious diseases * Obesity (body mass index ≥ 30 kg/m²) * Comorbid personality disorders * Concurrent use of anti-inflammatory medications or antioxidant supplements * Substance use disorder within the preceding 6 months