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

NCT05927129 | Unknown

• 1 other identifier: 2022-KY1-001-070
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Keywords

Functional Near-Infrared Spectroscopy; fNIRS; depression; Biological Mechanism; Psychotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 4-weeks, 8-weeks,12-weeks.

Secondary Outcomes (3)

• Change in remission rate of Patient Health Questionnaire-9 (PHQ-9) score after treatment.

  Baseline, 4-weeks, 8-weeks,12-weeks.

• Change in remission rate of the Beck Depression Inventory (BDI) score after treatment.

  Baseline, 4-weeks, 8-weeks,12-weeks.

• Change in remission rate of the Beck Scale for Suicidal Ideation (SSI) score after treatment.

  Baseline, 4-weeks, 8-weeks,12-weeks.

Other Outcomes (4)

• Change in the score of THINC-it.

  Baseline, 4-weeks, 8-weeks,12-weeks.

• Change in neuroimaging using functional magnetic resonance

  Baseline, 12-weeks.

• Change in electroencephalogram

  Baseline, 12-weeks.

Study Arms (3)

medication therapy group

ACTIVE COMPARATOR

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

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.

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.

Other: The combination of antidepressant and IPT

Interventions

Antidepressant DRUG

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.

medication therapy group

Psychotherapy IPT OTHER

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.

Interpersonal Psychotherapy group

The combination of antidepressant and IPT OTHER

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.

combination of medication therapy and Interpersonal Psychotherapy group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Physical illnesses that significantly impact communication and mobility.
• Co-occurring psychiatric disorders other than depression.
• History of substance dependence or substance addiction.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Zhejiang, Hangzhou, 310000, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

Antidepressive Agents; adenylate isopentenyltransferase

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Chanchan Hu, Bachelor

CONTACT

87235948; violahu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 3, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CN (1)