Needle-embedding Therapy Alleviates Depressive Symptoms and Resets the Function of Executive Control System in Subthreshold Depression People

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status: Unknown

Conditions: Subthreshold Depression

Treatments: Device: shame needle-embedding therapy; Procedure: needle-embedding therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04319562

YN2019ML13

Details and patient eligibility

About

The main objective of this trial is to evaluate the effectiveness of treating subthreshold depression by needle-embedding therapy. On this basis, the investigators will discuss the mechanism of needle-embedding therapy improving executive function control system.

Full description

The needle-embedding therapy is a method of acupuncture, which inserts the intradermal thumbtack needle into skin quickly. The needle will be replaced after 2 or 3 days. This treatment has a great efficacy on subthreshold depression (SD) and it is easy to promote. However, its clinical effect remains to be studied. In this study, the researchers used this method to treat SD by selecting the back shu acupoint and ear acupoint.

This research aims to evaluate the effectiveness of treating subthreshold depression by needle-embedding therapy. On this basis, from the perspective of psychology, this project takes the cognitive function of the SD people as the entry point, in order to find the scientific indicators to quantify the SD people clinically from the perspective of the executive function control system. At the same time, magnetic resonance imaging(MRI) was used to compare and analyze the brain executive control system of subthreshold depression group and normal group, and to observe the specificity of brain structure, network and function of subthreshold depression group. Finally, through the comparative analysis of the brain executive control system of the subthreshold depression group with intradermal thumbtack needle therapy and shame intradermal thumbtack needle therapy, the neural mechanism of needle-embedding therapy promoting the function reset of the brain executive control system was speculated based on the evaluation of the efficacy of needle-embedding therapy.

80 patients will be divided into two groups randomly, intradermal thumbtack needle group or shame intradermal thumbtack needle group, and evaluated before and after intervention.

The primary study outcomes will be depressive symptoms as measured by the PHQ-9. Secondary outcomes will be the ability of executive control system, health-related quality of life and anxiety symptoms measured as described previously. Tertiary outcomes will be the difference between the results of fMRI of SD people and normal brain database, and the difference between the treatment group and control group, which can observe the specificity of brain structure, network and function in subthreshold depression.

The results will be analyzed and presented descriptively, as of statistical comparisons of pre- and post-treatment and the relationship between the groups.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Applicants self-identifying with a diminished mood who

• screened positive for subthreshold depressive symptoms (Centre for Epidemiological Studies Depression Scale (CES-D) ≥ 16;
• were scheduled for a semistructural clinical interview (the Mini International Neuropsychiatric Interview, the MINI) conducted by specialists in psychiatry to diagnose whether they are SD；
• were not currently receiving or had a plan to receive a psychotherapy for any kind of mental health problem；
• had had no psychotherapy for any kind of mental health disorder in the past six months.

Exclusion criteria

patients had

• antidepressant use
• alcohol dependency
• psychosis
• recent suicidalrisk
• significant cognitive impairment
• recent bereavement
• terminal illness on clinical grounds

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

needle-embedding therapy

Experimental group

Description:

The participants in this group will be treated with intradermal thumbtack needle.

Treatment:

Procedure: needle-embedding therapy

shame needle-embedding therapy

Sham Comparator group

Description:

The participants in this group will be treated with shame intradermal thumbtack needle.

Treatment:

Device: shame needle-embedding therapy