Clinical trial NCT05927129: Research on the Biological Mechanism of the Efficacy of Psychotherapy for Depression Based on the fNIRS
Official title: Research on the Biological Mechanism of the Efficacy of Psychotherapy for Depression Based on the Near-Infrared Functional Imaging System (fNIRS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder
Keywords: Functional Near-Infrared Spectroscopy
fNIRS
depression
Biological Mechanism
Psychotherapy
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in fNIRS (functional Near-Infrared Spectroscopy) after treatment.
timeFrame: Baseline, 4-weeks, 8-weeks,12-weeks.
measure: Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
timeFrame: Baseline, 4-weeks, 8-weeks,12-weeks.
Secondary outcomes:
measure: Change in remission rate of Patient Health Questionnaire-9 (PHQ-9) score after treatment.
timeFrame: Baseline, 4-weeks, 8-weeks,12-weeks.
measure: Change in remission rate of the Beck Depression Inventory (BDI) score after treatment.
timeFrame: Baseline, 4-weeks, 8-weeks,12-weeks.
measure: Change in remission rate of the Beck Scale for Suicidal Ideation (SSI) score after treatment.
timeFrame: Baseline, 4-weeks, 8-weeks,12-weeks.
Other outcomes:
measure: Change in the score of THINC-it.
timeFrame: Baseline, 4-weeks, 8-weeks,12-weeks.
measure: Change in neuroimaging using functional magnetic resonance
timeFrame: Baseline, 12-weeks.
measure: Change in electroencephalogram
timeFrame: Baseline, 12-weeks.
measure: Change of blood factor levels
timeFrame: Baseline, 8weeks, 12-weeks.
Locations:
city: Zhejiang
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Hangzhou
Study officials:
References: