NCT07671040Completed
A Pilot Study of Adjunctive Structured Supportive Psychotherapy in Schizophrenia
Effects of Adjunctive Structured Supportive Psychotherapy on Cognitive Function and Serum High-Sensitivity C-Reactive Protein in Schizophrenia: A Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 22 Jun 2026
- Start date
- 1 Mar 2025
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Hasanuddin University
- Diseases
- Schizophrenia
- NCT number
- NCT07671040
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 1 Mar 2025 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of anti-inflammatory medications or antioxidant supplements
Other illness
- Febrile conditions at time of screening
- Organic comorbid diseases
- Active infectious diseases
- Comorbid personality disorders
- Substance use disorder within the preceding 6 months
Other
- Obesity (body mass index ≥ 30 kg/m²)
Who the study is looking for
- 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
Age in the registry: 20 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychiatry, Faculty of Medicine, Hasanuddin University Coordinator of this site? Confirm its status | Makassar | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.