NCT05927129

Research on the Biological Mechanism of the Efficacy of Psychotherapy for Depression Based on the fNIRS

Research on the Biological Mechanism of the Efficacy of Psychotherapy for Depression Based on the Near-Infrared Functional Imaging System (fNIRS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

In this project, the investigators will implement medication therapy, psychotherapy, and a combination of medication therapy with psychotherapy, specifically utilizing IPT, in patients with depression. Simultaneously, the investigators will conduct comprehensive fNIRS assessments on all patients to evaluate changes in their brain function and determine the level of effectiveness of psychotherapy. The investigators will also employ standardized psychological assessments to evaluate patients, allowing for a comparison of the effectiveness of fNIRS assessments and providing clarity on the efficacy of psychotherapy in patients with depression, as the investigatorsll as the differential efficacy of different treatment approaches, and establishing the biological markers of psychotherapy. Additionally, the investigators will collect blood samples, cranial magnetic resonance images, and electroencephalograms from patients before and after treatment, which will contribute to further exploration of treatment mechanisms in the future.

Detailed description

This study utilizes the Near-Infrared Functional Imaging System (fNIRS) as a biological marker for psychotherapy. The investigators propose the following scientific hypothesis: In patients with depression, levels of oxygenated hemoglobin and deoxygenated hemoglobin in different brain regions may fluctuate at different stages of the disease progression and treatment, along with changes in the activation levels of different brain regions. Neuroimaging studies on the neurobiological mechanisms of depression suggest a reduction in gray matter volume in emotion processing areas such as the limbic system, hippocampus, anterior cingulate cortex, dorsolateral prefrontal cortex, and basal ganglia. Previous neuroimaging studies have found that successful cognitive-behavioral therapy (CBT) accompanied changes in gray matter volume in the brain, as observed through fMRI. Interpersonal Psychotherapy (IPT), which is a component of the third wave of CBT, is expected to exhibit more significant expression in cognitive task-based fNIRS during IPT treatment for depression. In this project, the investigators will implement medication therapy, psychotherapy, and a combination of medication therapy with psychotherapy, specifically utilizing IPT, in patients with depression. Simultaneously, the investigators will conduct comprehensive fNIRS assessments on all patients to evaluate changes in their brain function and determine the level of effectiveness of psychotherapy. The investigators will also employ standardized psychological assessments to evaluate patients, allowing for a comparison of the effectiveness of fNIRS assessments and providing clarity on the efficacy of psychotherapy in patients with depression, as the investigatorsll as the differential efficacy of different treatment approaches, and establishing the biological markers of psychotherapy. Additionally, the investigators will collect blood samples, cranial magnetic resonance images, and electroencephalograms from patients before and after treatment, which will contribute to further exploration of treatment mechanisms in the future.

Conditions

• Depressive Disorder

Interventions

Type	Name	Description
DRUG	Antidepressant	Patients will receive standardized treatment with antidepressant, and their treatment efficacy will be assessed by a blinded psychological assessor using validated rating scales. The assessment will be conducted monthly, and evaluations will be tracked for a period of three months.
OTHER	Psychotherapy IPT	The participants will receive standardized IPT treatment for 12 weeks. Patients will receive standardized treatment, and their treatment efficacy will be assessed by a blinded psychological assessor using validated rating scales. The assessment will be conducted monthly, and evaluations will be tracked for a period of three months.
OTHER	The combination of antidepressant and IPT	The participants will receive standardized IPT treatment for 12 weeks. Also，long-term antidepressant will be administered in accordance with clinical guidelines. Patients will receive standardized treatment, and their treatment efficacy will be assessed by a blinded psychological assessor using validated rating scales. The assessment will be conducted monthly, and evaluations will be tracked for a period of three months.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: China