Research on the Biological Mechanism of the Efficacy of Psychotherapy for Depression Based on the fNIRS
NCT ID: NCT05927129
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2022-01-01
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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medication therapy group
Patients randomized to the medication therapy group will receive standardized treatment with antidepressant medications according to clinical guidelines.
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.
Interpersonal Psychotherapy group
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.
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.
combination of medication therapy and Interpersonal Psychotherapy group
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Co-occurring psychiatric disorders other than depression.
* History of substance dependence or substance addiction.
16 Years
50 Years
ALL
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Zhejiang University
Zhejiang, Hangzhou, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-KY1-001-070
Identifier Type: -
Identifier Source: org_study_id
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