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

Zhejiang University

Status: Enrolling

Conditions: Depressive Disorder

Treatments: Other: The combination of antidepressant and IPT; Drug: Antidepressant; Other: Psychotherapy IPT

Study type: Interventional

Funder types: Other

Identifiers

NCT05927129

2022-KY1-001-070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet the diagnostic criteria for depression according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition).
• Have at least a junior high school education or higher.
• Age between 16 and 50 years old.
• Grew up in a Chinese-speaking environment and are proficient in Mandarin Chinese for effective communication.

Exclusion criteria

• Physical illnesses that significantly impact communication and mobility.
• Co-occurring psychiatric disorders other than depression.
• History of substance dependence or substance addiction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 3 patient groups

medication therapy group

Active Comparator group

Description:

Patients randomized to the medication therapy group will receive standardized treatment with antidepressant medications according to clinical guidelines.

Treatment:

Drug: Antidepressant

Interpersonal Psychotherapy group

Active Comparator group

Description:

The participants will receive standardized IPT treatment for 12 weeks. IPT therapists have received training from IPT workshops in both China and the United States and obtained the corresponding certifications. IPT therapists focus on the interpersonal domains associated with the onset and maintenance of depression. They guide clients in identifying the connections between their emotional changes and interpersonal difficulties, exploring problems, actively seeking potential interpersonal support and assistance, improving interpersonal skills, helping clients alleviate symptoms, enhance their quality of life, and adapt better to society.

Treatment:

Other: Psychotherapy IPT

combination of medication therapy and Interpersonal Psychotherapy group

Experimental group

Description:

Patients randomized to this group will receive standardized treatment with antidepressant medications according to clinical guidelines. The participants will also receive standardized IPT treatment for 12 weeks. IPT therapists have received training from IPT workshops in both China and the United States and obtained the corresponding certifications. IPT therapists focus on the interpersonal domains associated with the onset and maintenance of depression. They guide clients in identifying the connections between their emotional changes and interpersonal difficulties, exploring problems, actively seeking potential interpersonal support and assistance, improving interpersonal skills, helping clients alleviate symptoms, enhance their quality of life, and adapt better to society.

Treatment:

Other: The combination of antidepressant and IPT