Depressive DisorderNCT05927129
Research on the Biological Mechanism of the Efficacy of Psychotherapy for Depression Based on the fNIRS
A study testing Antidepressant, Psychotherapy IPT and The combination of antidepressant and IPT in people with Depressive Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Antidepressant, Psychotherapy IPT and The combination of antidepressant and IPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Physical illnesses that significantly impact communication and mobility.
- Co-occurring psychiatric disorders other than depression.
- History of substance dependence or substance addiction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Zhejiang, Hangzhou, 310000
Chanchan Hu, Bachelor, 87235948 ext. 0571, violahu@126.com
About this study
Official title: Research on the Biological Mechanism of the Efficacy of Psychotherapy for Depression Based on the Near-Infrared Functional Imaging System (fNIRS)
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.
Read the 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
- Being tested
- Antidepressant, Psychotherapy IPT, The combination of antidepressant and IPT
- Keywords
- Functional Near-Infrared Spectroscopy, fNIRS, depression, Biological Mechanism, Psychotherapy
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantDrug
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.
Psychotherapy IPTOther
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.
The combination of antidepressant and IPTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| medication therapy group | Active comparator | Patients randomized to the medication therapy group will receive standardized treatment with antidepressant medications according to clinical guidelines. Receives: Drug: Antidepressant |
| Interpersonal Psychotherapy group | Active comparator | 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. Receives: Other: Psychotherapy IPT |
| combination of medication therapy and Interpersonal Psychotherapy group | Experimental | 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. Receives: Other: The combination of antidepressant and IPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4-weeks, 8-weeks,12-weeks.
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.
Measured: Baseline, 4-weeks, 8-weeks,12-weeks.
Secondary outcomes (3)
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.
Measured: Baseline, 4-weeks, 8-weeks,12-weeks.
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.
Measured: Baseline, 4-weeks, 8-weeks,12-weeks.
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.
Measured: Baseline, 4-weeks, 8-weeks,12-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927129
- Sponsor's protocol ID
- 2022-KY1-001-070
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Biological Mechanism of the Efficacy of Psychotherapy for Depression Based on the Near-Infrared Functional Imaging System (fNIRS)
- ClinicalTrials.gov ID
- NCT05927129
- Acronym / sponsor ID
- 2022-KY1-001-070
- Conditions
- Depressive Disorder
- Keywords
- Functional Near-Infrared Spectroscopy, fNIRS, depression, Biological Mechanism, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| medication therapy group | Active comparator | Drug: AntidepressantPatients randomized to the medication therapy group will receive standardized treatment with antidepressant medications according to clinical guidelines. |
| Interpersonal Psychotherapy group | Active comparator | Other: Psychotherapy IPTThe 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. |
| combination of medication therapy and Interpersonal Psychotherapy group | Experimental | Other: The combination of antidepressant and IPTPatients 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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Physical illnesses that significantly impact communication and mobility.
- Co-occurring psychiatric disorders other than depression.
- History of substance dependence or substance addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntidepressantPatients 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. | Drug | medication therapy group |
| Psychotherapy IPTThe 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 | Interpersonal Psychotherapy group |
| The combination of antidepressant and IPTThe 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. | Other | combination of medication therapy and Interpersonal Psychotherapy group |
Primary outcome
Changes in fNIRS (functional Near-Infrared Spectroscopy) after treatment.
Time frame: Baseline, 4-weeks, 8-weeks,12-weeks.
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.
Time frame: Baseline, 4-weeks, 8-weeks,12-weeks.
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.
3 secondary outcomes
Change in remission rate of Patient Health Questionnaire-9 (PHQ-9) score after treatment.
Time frame: Baseline, 4-weeks, 8-weeks,12-weeks.
Change in remission rate of the Beck Depression Inventory (BDI) score after treatment.
Time frame: Baseline, 4-weeks, 8-weeks,12-weeks.
Change in remission rate of the Beck Scale for Suicidal Ideation (SSI) score after treatment.
Time frame: Baseline, 4-weeks, 8-weeks,12-weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antidepressant, Psychotherapy IPT and The combination of antidepressant and IPT in people with Depressive Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chanchan Hu, Bachelor (87235948 ext. 0571, violahu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fNIRS (functional Near-Infrared Spectroscopy) after treatment. (time frame: Baseline, 4-weeks, 8-weeks,12-weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.