A Pilot Study of Adjunctive Structured Supportive Psychotherapy in Schizophrenia

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.

Conditions

• Schizophrenia
• Cognitive and Executive Dysfunction
• Neuroinflammation

Interventions

BEHAVIORAL

Structured supportive psychotherapy

Structured supportive psychotherapy using the Supportive Psychotherapy Module for Schizophrenia, 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).

DRUG

Risperidone

Risperidone 4 mg/day (2 mg tablet twice daily, oral administration) for 12 weeks

BEHAVIORAL

Unstructured Supportive Conversation

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

Sponsors & Collaborators

• Hasanuddin University

  lead OTHER

Principal Investigators

• Indrawaty Suhuyanli, MD · Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, Indonesia

• Agus Durman, MD · Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, Indonesia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• Indonesia

Study Locations