Schizophrenia PatientsCBT-SCZ-NLRNCT07524868
Effect of Cognitive Behavioral Therapy on Auditory Hallucinations and NLR in Schizophrenia Patients
A study testing Cognitive Behavioral Therapy (CBT) and risperidone in people with Schizophrenia Patients and Auditory Hallucination, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
This study aims to evaluate the effectiveness of Cognitive Behavioral Therapy (CBT) as an adjunctive treatment to pharmacotherapy in reducing auditory hallucinations and inflammation, as measured by the neutrophil-to-lymphocyte ratio (NLR), in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Schizophrenia Patients, Auditory Hallucination
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and risperidone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with schizophrenia based on clinical assessment
- Age 18-60 years
- Experiencing auditory hallucinations
- Currently receiving antipsychotic treatment (e.g., risperidone)
- Able to communicate and participate in Cognitive Behavioral Therapy (CBT)
- Willing to provide informed consent
Who cannot join
- Presence of severe medical or neurological illness
- Substance use disorder (excluding nicotine)
- Severe cognitive impairment or inability to participate in interviews
- Patients with acute agitation or requiring emergency intervention
- Currently receiving structured psychotherapy other than CBT
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Regional Special Hospital (RSKD) Dadi, South Sulawesi, Indonesia
Makassar, South Sulawesi, 90245
About this study
Official title: Effectiveness of Cognitive Behavioral Therapy as an Adjunctive Treatment on Auditory Hallucinations and Neutrophil-to-Lymphocyte Ratio in Patients With Schizophrenia Receiving Risperidone
This study aims to evaluate the effectiveness of Cognitive Behavioral Therapy (CBT) as an adjunctive treatment to pharmacotherapy in reducing auditory hallucinations and inflammation, as measured by the neutrophil-to-lymphocyte ratio (NLR), in patients with schizophrenia.
Schizophrenia is a chronic psychiatric disorder characterized by positive symptoms, including auditory hallucinations, which significantly impair functioning and quality of life. While antipsychotic medications such as risperidone are effective in managing symptoms, a substantial proportion of patients continue to experience persistent hallucinations. Cognitive Behavioral Therapy (CBT) has been shown to improve coping strategies and reduce distress associated with hallucinations.
Read more
Recent evidence suggests that inflammation plays a role in the pathophysiology of schizophrenia. The neutrophil-to-lymphocyte ratio (NLR) is a simple and accessible biomarker of systemic inflammation and has been associated with symptom severity in schizophrenia. However, limited studies have explored whether psychological interventions such as CBT can influence inflammatory markers.
This study uses a quasi-experimental design involving two groups: an intervention group receiving CBT in addition to standard pharmacotherapy, and a control group receiving pharmacotherapy alone. CBT will be delivered in structured sessions focusing on cognitive restructuring, behavioral modification, and coping strategies for auditory hallucinations.
Clinical outcomes will be assessed using the Psychotic Symptom Rating Scales (PSYRATS) for auditory hallucinations, while inflammatory status will be measured using NLR obtained from peripheral blood samples. Assessments will be conducted before and after the intervention period.
The findings of this study are expected to provide evidence on the effectiveness of CBT not only in improving clinical symptoms but also in potentially modulating inflammatory processes in patients with schizophrenia.
Read the detailed description
Schizophrenia is associated with both neurobiological and psychosocial dysfunctions, including persistent auditory hallucinations and systemic inflammation. The neutrophil-to-lymphocyte ratio (NLR) has emerged as a potential biomarker reflecting inflammatory processes in schizophrenia.
Cognitive Behavioral Therapy (CBT) is an evidence-based psychological intervention that helps patients modify maladaptive beliefs and reduce distress related to psychotic symptoms. However, its potential impact on biological markers such as NLR remains underexplored.
This study employs a quasi-experimental design with a pre-test and post-test control group. Participants diagnosed with schizophrenia and experiencing auditory hallucinations are divided into two groups: one receiving standard pharmacological treatment with risperidone, and the other receiving adjunctive CBT.
The primary outcomes include changes in auditory hallucination severity measured by PSYRATS and changes in NLR levels. The study aims to explore the integration of psychological and biological perspectives in schizophrenia treatment.
- Conditions
- Schizophrenia Patients, Auditory Hallucination
- Being tested
- Cognitive Behavioral Therapy (CBT), risperidone
- Keywords
- Cognitive Behavioral Therapy, Schizophrenia, Auditory Hallucinations, Neutrophil to Lymphocyte Ratio, Inflammation, Risperidone
- Medical subject headings
- Hallucinations, Schizophrenia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Also called CBT, Cognitive Therapy
Cognitive behavioral therapy (CBT) will be provided in structured sessions focusing on identifying and modifying maladaptive thoughts and beliefs related to auditory hallucinations. Therapy will be delivered in multiple sessions over the study period by trained therapists.
risperidoneDrug
Also called risperdal, Antipsychotic
Participants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy.
| Study group | Role | What they receive |
|---|---|---|
| CBT + Pharmacotherapy | Experimental | Participants receive cognitive behavioral therapy (CBT) in addition to standard pharmacological treatment (risperidone). Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Drug: risperidone |
| Pharmacotherapy Only | Active comparator | Participants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy. Receives: Drug: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in auditory hallucination severity (PSYRATS)
Change in auditory hallucination severity measured using the Psychotic Symptom Rating Scales (PSYRATS) - Auditory Hallucination Subscale. The total score ranges from 0 to 44, with higher scores indicating more severe symptoms
Measured: Baseline to 10 weeks
Secondary outcomes (1)
Change in neutrophil-to-lymphocyte ratio (NLR)
Change in inflammatory status measured using the neutrophil-to-lymphocyte ratio (NLR). Higher values indicate greater systemic inflammation.
Measured: Baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Nov 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into two parallel groups: an intervention group receiving cognitive behavioral therapy (CBT) in addition to standard pharmacological treatment, and a control group receiving standard pharmacological treatment alone. Outcome measures, including clinical symptoms and inflammatory markers, will be assessed at baseline and after the intervention period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinvil Renaldi, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524868
- Sponsor's protocol ID
- CBT-SCZ-NLR-2026
- Other IDs
- UNHAS-PSY-2026
- Acronym
- CBT-SCZ-NLR
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive Behavioral Therapy as an Adjunctive Treatment on Auditory Hallucinations and Neutrophil-to-Lymphocyte Ratio in Patients With Schizophrenia Receiving Risperidone
- ClinicalTrials.gov ID
- NCT07524868
- Acronym / sponsor ID
- CBT-SCZ-NLR / CBT-SCZ-NLR-2026
- Conditions
- Schizophrenia Patients, Auditory Hallucination
- Keywords
- Cognitive Behavioral Therapy, Schizophrenia, Auditory Hallucinations, Neutrophil to Lymphocyte Ratio, Inflammation, Risperidone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of Cognitive Behavioral Therapy (CBT) as an adjunctive treatment to pharmacotherapy in reducing auditory hallucinations and inflammation, as measured by the neutrophil-to-lymphocyte ratio (NLR), in patients with schizophrenia.
Schizophrenia is a chronic psychiatric disorder characterized by positive symptoms, including auditory hallucinations, which significantly impair functioning and quality of life. While antipsychotic medications such as risperidone are effective in managing symptoms, a substantial proportion of patients continue to experience persistent hallucinations. Cognitive Behavioral Therapy (CBT) has been shown to improve coping strategies and reduce distress associated with hallucinations.
Recent evidence suggests that inflammation plays a role in the pathophysiology of schizophrenia. The neutrophil-to-lymphocyte ratio (NLR) is a simple and accessible biomarker of systemic inflammation and has been associated with symptom severity in schizophrenia. However, limited studies have explored whether psychological interventions such as CBT can influence inflammatory markers.
This study uses a quasi-experimental design involving two groups: an intervention group receiving CBT in addition to standard pharmacotherapy, and a control group receiving pharmacotherapy alone. CBT will be delivered in structured sessions focusing on cognitive restructuring, behavioral modification, and coping strategies for auditory hallucinations.
Clinical outcomes will be assessed using the Psychotic Symptom Rating Scales (PSYRATS) for auditory hallucinations, while inflammatory status will be measured using NLR obtained from peripheral blood samples. Assessments will be conducted before and after the intervention period.
The findings of this study are expected to provide evidence on the effectiveness of CBT not only in improving clinical symptoms but also in potentially modulating inflammatory processes in patients with schizophrenia.
Detailed description
Schizophrenia is associated with both neurobiological and psychosocial dysfunctions, including persistent auditory hallucinations and systemic inflammation. The neutrophil-to-lymphocyte ratio (NLR) has emerged as a potential biomarker reflecting inflammatory processes in schizophrenia.
Cognitive Behavioral Therapy (CBT) is an evidence-based psychological intervention that helps patients modify maladaptive beliefs and reduce distress related to psychotic symptoms. However, its potential impact on biological markers such as NLR remains underexplored.
This study employs a quasi-experimental design with a pre-test and post-test control group. Participants diagnosed with schizophrenia and experiencing auditory hallucinations are divided into two groups: one receiving standard pharmacological treatment with risperidone, and the other receiving adjunctive CBT.
The primary outcomes include changes in auditory hallucination severity measured by PSYRATS and changes in NLR levels. The study aims to explore the integration of psychological and biological perspectives in schizophrenia treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups: an intervention group receiving cognitive behavioral therapy (CBT) in addition to standard pharmacological treatment, and a control group receiving standard pharmacological treatment alone. Outcome measures, including clinical symptoms and inflammatory markers, will be assessed at baseline and after the intervention period.
| Arm | Type | Receives |
|---|---|---|
| CBT + Pharmacotherapy | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Drug: risperidoneParticipants receive cognitive behavioral therapy (CBT) in addition to standard pharmacological treatment (risperidone). |
| Pharmacotherapy Only | Active comparator | Drug: risperidoneParticipants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients diagnosed with schizophrenia based on clinical assessment
- Age 18-60 years
- Experiencing auditory hallucinations
- Currently receiving antipsychotic treatment (e.g., risperidone)
- Able to communicate and participate in Cognitive Behavioral Therapy (CBT)
Key exclusion criteria (5 listed)
- Presence of severe medical or neurological illness
- Substance use disorder (excluding nicotine)
- Severe cognitive impairment or inability to participate in interviews
- Patients with acute agitation or requiring emergency intervention
- Currently receiving structured psychotherapy other than CBT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)Also: CBT, Cognitive TherapyCognitive behavioral therapy (CBT) will be provided in structured sessions focusing on identifying and modifying maladaptive thoughts and beliefs related to auditory hallucinations. Therapy will be delivered in multiple sessions over the study period by trained therapists. | Behavioural | CBT + Pharmacotherapy |
| risperidoneAlso: risperdal, AntipsychoticParticipants receive standard pharmacological treatment (risperidone) without cognitive behavioral therapy. | Drug | CBT + Pharmacotherapy, Pharmacotherapy Only |
Primary outcome
Change in auditory hallucination severity (PSYRATS)
Time frame: Baseline to 10 weeks
Change in auditory hallucination severity measured using the Psychotic Symptom Rating Scales (PSYRATS) - Auditory Hallucination Subscale. The total score ranges from 0 to 44, with higher scores indicating more severe symptoms
1 secondary outcome
Change in neutrophil-to-lymphocyte ratio (NLR)
Time frame: Baseline to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) and risperidone in people with Schizophrenia Patients and Auditory Hallucination, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in auditory hallucination severity (PSYRATS) (time frame: Baseline to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.