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A Pilot Study of Adjunctive Structured Supportive Psychotherapy in Schizophrenia
Sponsor: Hasanuddin University
Summary
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.
Official title: Effects of Adjunctive Structured Supportive Psychotherapy on Cognitive Function and Serum High-Sensitivity C-Reactive Protein in Schizophrenia: A Pilot Randomized Controlled Trial
Key Details
Gender
All
Age Range
20 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2025-03-01
Completion Date
2025-06-30
Last Updated
2026-06-26
Healthy Volunteers
No
Interventions
Structured supportive psychotherapy
Structured supportive psychotherapy using the Supportive Psychotherapy Module for Schizophrenia (Suhuyanli et al., 2022), nationally validated in the Indonesian population. Sessions progressed across three structured phases: Sessions 1-3 established therapeutic alliance and clinical formulation; Sessions 4-9 addressed psychoeducation, coping strategies, reality testing, and adherence reinforcement; and Sessions 10-12 consolidated treatment gains and planned relapse prevention. Protocol fidelity required completion of at least 10 of 12 sessions, monitored by an independent rater using a structured checklist (inter-rater agreement κ = 0.84).
Risperidone 2 mg
Risperidone 4 mg/day (2 mg tablet twice daily, oral administration) for 12 weeks.
Standard Clinical Care with Active Control
Participants in the active control arm received an identical schedule of individual sessions over the 12-week period, administered by three board-certified psychiatrists of comparable clinical expertise. This design ensured an equivalent total contact time of approximately 540-720 minutes per participant, consisting strictly of Standard Clinical Care with Active Control
Risperidone 2 mg
Risperidone 4 mg/day (2 mg tablet twice daily, oral administration) for 12 weeks
Locations (1)
Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Jl. Perintis Kemerdekaan Km. 10, Tamalanrea Makassar 90245, South Sulawesi, Indonesia
Makassar, South Sulawesi, Indonesia