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

Primary Purpose

Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Antidepressant
Psychotherapy IPT
The combination of antidepressant and IPT
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Functional Near-Infrared Spectroscopy, fNIRS, depression, Biological Mechanism, Psychotherapy

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • The First Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

medication therapy group

Interpersonal Psychotherapy group

combination of medication therapy and Interpersonal Psychotherapy group

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Changes in fNIRS (functional Near-Infrared Spectroscopy) after treatment.
The instrument used in this study is a 52-channel Near-Infrared Spectroscopy (fNIRS) brain imaging system. It indirectly calculates the relative changes in levels of oxygenated and deoxygenated hemoglobin in different brain regions by detecting two different wavelengths of near-infrared light (695 nanometers and 830 nanometers). These changes reflect alterations in brain function. The instrument primarily utilizes 17 optical emitters and 16 optical detectors to acquire data. The emitters and detectors are positioned 3.0 centimeters apart, and the measurement area between the probes is defined as a channel. The NIRS probes are arranged in a 3×11 matrix, forming 52 measurement channels. Following the international 10-20 system, the lowest channel is aligned with the Fp1-Fp2 line. The probe coverage of this instrument allows for the measurement of relative changes in oxygenated and deoxygenated hemoglobin signals in bilateral frontal and temporal cortical regions.
Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
The Hamilton Depression Scale (24-items) (HAM-D24), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. Remission is defined as HAM-D24 ≤8.

Secondary Outcome Measures

Change in remission rate of Patient Health Questionnaire-9 (PHQ-9) score after treatment.
The Patient Health Questionnaire-9 (PHQ-9) is a screening tool used to assess symptoms of depression. It consists of nine questions that are designed to measure the severity of depressive symptoms experienced by an individual. Each question corresponds to one of the nine criteria for major depressive disorder as outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Each question is scored on a scale from 0 to 3, with higher scores indicating greater severity of symptoms. The total score ranges from 0 to 27, with higher scores indicating a higher likelihood of clinical depression. The PHQ-9 is widely used in both clinical and research settings to assess the presence and severity of depressive symptoms, monitor treatment progress, and aid in the diagnosis of depression.
Change in remission rate of the Beck Depression Inventory (BDI) score after treatment.
The Beck Depression Inventory (BDI) is a widely used self-assessment tool for screening depression. Developed by American psychologist Aaron T. Beck in 1961, it aims to measure the severity of depressive symptoms experienced by an individual. The BDI consists of 21 items, each describing different aspects of depressive symptoms such as mood, loss of interest in activities, self-evaluation, changes in weight, sleep quality, and more. Individuals are required to rate their experiences based on a four-point scale ranging from 0 to 3, reflecting the intensity of each symptom. The total score on the BDI can range from 0 to 63, with higher scores indicating more severe depressive symptoms. The questionnaire is designed to assess the presence and severity of depression, monitor treatment progress, and aid in the diagnosis of depression.
Change in remission rate of the Beck Scale for Suicidal Ideation (SSI) score after treatment.
The Beck Scale for Suicidal Ideation (SSI) is a self-report questionnaire designed to assess the presence and severity of suicidal thoughts and ideation. It was developed by Aaron T. Beck, a renowned psychologist, to aid in the evaluation of suicidal risk. The SSI consists of 19 items that explore different dimensions of suicidal ideation, including the intensity, frequency, duration, and specificity of suicidal thoughts. The questionnaire assesses both passive (e.g., "I wish I were dead") and active (e.g., "I have a plan to kill myself") suicidal ideation. Each item is rated on a scale from 0 to 2, with higher scores indicating a greater severity of suicidal ideation. The total score on the SSI can range from 0 to 38, providing an overall assessment of the individual's suicidal thoughts.

Full Information

First Posted
June 13, 2023
Last Updated
June 23, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05927129
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Functional Near-Infrared Spectroscopy, fNIRS, depression, Biological Mechanism, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
medication therapy group
Arm Type
Active Comparator
Arm Description
Patients randomized to the medication therapy group will receive standardized treatment with antidepressant medications according to clinical guidelines.
Arm Title
Interpersonal Psychotherapy group
Arm Type
Active Comparator
Arm 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.
Arm Title
combination of medication therapy and Interpersonal Psychotherapy group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Antidepressant
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Psychotherapy IPT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The combination of antidepressant and IPT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in fNIRS (functional Near-Infrared Spectroscopy) after treatment.
Description
The instrument used in this study is a 52-channel Near-Infrared Spectroscopy (fNIRS) brain imaging system. It indirectly calculates the relative changes in levels of oxygenated and deoxygenated hemoglobin in different brain regions by detecting two different wavelengths of near-infrared light (695 nanometers and 830 nanometers). These changes reflect alterations in brain function. The instrument primarily utilizes 17 optical emitters and 16 optical detectors to acquire data. The emitters and detectors are positioned 3.0 centimeters apart, and the measurement area between the probes is defined as a channel. The NIRS probes are arranged in a 3×11 matrix, forming 52 measurement channels. Following the international 10-20 system, the lowest channel is aligned with the Fp1-Fp2 line. The probe coverage of this instrument allows for the measurement of relative changes in oxygenated and deoxygenated hemoglobin signals in bilateral frontal and temporal cortical regions.
Time Frame
Baseline, 4-weeks, 8-weeks,12-weeks.
Title
Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
Description
The Hamilton Depression Scale (24-items) (HAM-D24), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. Remission is defined as HAM-D24 ≤8.
Time Frame
Baseline, 4-weeks, 8-weeks,12-weeks.
Secondary Outcome Measure Information:
Title
Change in remission rate of Patient Health Questionnaire-9 (PHQ-9) score after treatment.
Description
The Patient Health Questionnaire-9 (PHQ-9) is a screening tool used to assess symptoms of depression. It consists of nine questions that are designed to measure the severity of depressive symptoms experienced by an individual. Each question corresponds to one of the nine criteria for major depressive disorder as outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Each question is scored on a scale from 0 to 3, with higher scores indicating greater severity of symptoms. The total score ranges from 0 to 27, with higher scores indicating a higher likelihood of clinical depression. The PHQ-9 is widely used in both clinical and research settings to assess the presence and severity of depressive symptoms, monitor treatment progress, and aid in the diagnosis of depression.
Time Frame
Baseline, 4-weeks, 8-weeks,12-weeks.
Title
Change in remission rate of the Beck Depression Inventory (BDI) score after treatment.
Description
The Beck Depression Inventory (BDI) is a widely used self-assessment tool for screening depression. Developed by American psychologist Aaron T. Beck in 1961, it aims to measure the severity of depressive symptoms experienced by an individual. The BDI consists of 21 items, each describing different aspects of depressive symptoms such as mood, loss of interest in activities, self-evaluation, changes in weight, sleep quality, and more. Individuals are required to rate their experiences based on a four-point scale ranging from 0 to 3, reflecting the intensity of each symptom. The total score on the BDI can range from 0 to 63, with higher scores indicating more severe depressive symptoms. The questionnaire is designed to assess the presence and severity of depression, monitor treatment progress, and aid in the diagnosis of depression.
Time Frame
Baseline, 4-weeks, 8-weeks,12-weeks.
Title
Change in remission rate of the Beck Scale for Suicidal Ideation (SSI) score after treatment.
Description
The Beck Scale for Suicidal Ideation (SSI) is a self-report questionnaire designed to assess the presence and severity of suicidal thoughts and ideation. It was developed by Aaron T. Beck, a renowned psychologist, to aid in the evaluation of suicidal risk. The SSI consists of 19 items that explore different dimensions of suicidal ideation, including the intensity, frequency, duration, and specificity of suicidal thoughts. The questionnaire assesses both passive (e.g., "I wish I were dead") and active (e.g., "I have a plan to kill myself") suicidal ideation. Each item is rated on a scale from 0 to 2, with higher scores indicating a greater severity of suicidal ideation. The total score on the SSI can range from 0 to 38, providing an overall assessment of the individual's suicidal thoughts.
Time Frame
Baseline, 4-weeks, 8-weeks,12-weeks.
Other Pre-specified Outcome Measures:
Title
Change in the score of THINC-it.
Description
THINC-it is a computerized cognitive screening tool that is designed to assess cognitive function in adults. THINC-it stands for "THINking Clearly," and it includes a series of brief tests that evaluate several cognitive domains, including attention, working memory, executive function, and processing speed. The tool is administered on a tablet or computer, and it takes approximately 20 minutes to complete.
Time Frame
Baseline, 4-weeks, 8-weeks,12-weeks.
Title
Change in neuroimaging using functional magnetic resonance
Description
Scanning functional magnetic resonance. Functional magnetic resonance imaging (fMRI) is a neuroimaging technique that is used to measure changes in brain activity by detecting changes in blood flow. In the context of depression, fMRI has been used to study changes in brain function that may be associated with the condition. Research using fMRI in depression has shown that there are alterations in the activity of certain brain regions in people with the condition. Specifically, fMRI studies have identified changes in the activity of the prefrontal cortex, the amygdala, and the hippocampus in people with major depression. Overall, fMRI has provided valuable insights into the neural mechanisms underlying major depression, and may help to inform the development of new treatments for the condition.
Time Frame
Baseline, 12-weeks.
Title
Change in electroencephalogram
Description
Electroencephalogram is collected from 64 electrodes. EEG can be used to identify patterns of brain activity that are associated with the condition and to inform treatment decisions. EEG can be a useful tool for identifying patterns of brain activity that are associated with depression and for guiding treatment decisions. Neurofeedback and TMS are two approaches that have shown promise in the treatment of depression. several parameters are analyzed to identify patterns of brain activity that may be associated with the condition.
Time Frame
Baseline, 12-weeks.
Title
Change of blood factor levels
Description
Factors carried by peripheral blood and exosomes. The factors include brain-derived neurotrophic fact, Reelin and other reported factors related to depression.
Time Frame
Baseline, 8weeks, 12-weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chanchan Hu, Bachelor
Phone
87235948
Ext
0571
Email
violahu@126.com
Facility Information:
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Zhejiang
State/Province
Hangzhou
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chanchan Hu, Bachelor
Phone
87235948
Ext
0571
Email
violahu@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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