Clinical trial
Research on the Biological Mechanism of the Efficacy of Psychotherapy for Depression Based on the Near-Infrared Functional Imaging System (fNIRS)
Name
2022-KY1-001-070
Description
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.
Trial arms
Trial start
2022-01-01
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Treatment
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.
Arms:
medication therapy group
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.
Arms:
Interpersonal Psychotherapy group
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.
Arms:
combination of medication therapy and Interpersonal Psychotherapy group
Size
90
Primary endpoint
Changes in fNIRS (functional Near-Infrared Spectroscopy) after treatment.
Baseline, 4-weeks, 8-weeks,12-weeks.
Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
Baseline, 4-weeks, 8-weeks,12-weeks.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-07-03
1 organization
1 product
1 indication
Organization
First Affiliated Hospital of Zhejiang UniversityProduct
AntidepressantIndication
Depression