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Efficacy and Mechanisms of Transtheoretical Model-Based Group Cognitive Behavioral Therapy (G-CBT) Combined with Transcranial Magnetic Stimulation (TMS) on Treatment-Resistant Auditory Hallucinations in Schizophrenia Patients: A Randomized Double-Blind Controlled Trial

Efficacy and mechanism of action of group cognitive behavioral therapy (G-CBT) combined with transcranial magnetic stimulation (TMS) in patients with schizophrenia based on a cross-theoretical model: a randomized double-blind placebo-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100683
Enrollment
Unknown
Registered
2025-04-14
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

G-CBT based on the transtheoretical model combined with transcranial magnetic stimulation (TMS) group:G-CBT based on the transtheoretical model combined with transcranial magnetic stimulation.
G-CBT based on the transtheoretical model combined with sham transcranial magnetic stimulation :G-CBT based on the transtheoretical model combined with sham transcranial magnetic stimulation.
General health education combined with transcranial magnetic stimulation (TMS) group:General health education combined with transcranial magnetic stimulation .
General health education combined with sham transcranial magnetic stimulation (sham TMS) group:General health education combined with sham transcranial magnetic stimulation (sham TMS).

Sponsors

The Affiliated Brain Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 2. Age 18~60 years old; 3. Positive and Negative Symptom Scale (PANSS) auditory hallucinations symptom score >=3 points; 4. Have been treated with adequate antipsychotic drugs> = 2 months; 5. Auditory hallucinations lasting for 3 months or more; 6. The patient or guardian signs informed consent.

Exclusion criteria

Exclusion criteria: 1.Hearing or visual impairments, severe physical illnesses, or substance abuse; 2.regnant or lactating women; 3.Contraindications to transcranial magnetic stimulation (TMS), such as a history of epilepsy or implanted metal devices; 4.Use of medications to improve cognitive function during the intervention period; 5.Modified electroconvulsive therapy (MECT) administered within the past month.

Design outcomes

Primary

MeasureTime frame
Hoffman Auditory Hallucinations Subscale Score;—

Secondary

MeasureTime frame
Positive and Negative Syndrome Scale (PANSS) Score;MATRICS Consensus Cognitive Battery (MCCB) Score;Personal and Social Performance Scale (PSP) Score;Clinical Efficacy Evaluation;—

Countries

China

Contacts

Public ContactLu Xiaobing

The Affiliated Brain Hospital of Guangzhou Medical University

13688876346@139.com+86 136 8887 6346

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026