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

Needle-embedding Therapy Alleviates Depressive Symptoms and Resets the Function of Executive Control System in Subthreshold Depression People: a Randomized Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Subthreshold Depression
• Intervention / Treatment: Procedure: needle-embedding therapy; Device: shame needle-embedding therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The Second Affiliated hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: needle-embedding therapy; The participants in this group will be treated with intradermal thumbtack needle.	Procedure: needle-embedding therapy; First group is comprised of Xinshu (BL15), Ganshu (BL18), Juque (CV14) bilaterally, and Xin and Gan of auricular point on the left ear. Second group includes Shentang (BL44), Hunmen (BL47), Jiuwei (RN15) bilaterally, and Xin and Gan of auricular point on the right side. After skin cleansing with a 75% alcohol swab, intradermal thumbtack needle will be quickly inserted into the skin and embedded at acupoints mentioned above bilaterally. The needles will remain in the acupoints for 3 days and they will be removed by the therapists at next visit. This also can ensure better implementation of the blind method.Participants are required to receive this treatment twice a week. The specification of the needle used in the back shu point is φ9mm 0.20×1.5mm (Seirin® PYONEX; Seirin Corporation, Shizuoka, Japan), that in the auricular point is φ9mm 0.20×0.6mm (Seirin® PYONEX; Seirin Corporation, Shizuoka, Japan).
Sham Comparator: shame needle-embedding therapy; The participants in this group will be treated with shame intradermal thumbtack needle.	Device: shame needle-embedding therapy; The acupoint selection in this group is the same as in the needle-embedding therapy group, except that the shame intradermal needles will be used. After skin cleansing with a 75% alcohol swab, the shame intradermal needles，instead of insert into the skin, it can only stick on the surface of the skin. It also will be removed by the therapists after 3 days. This takes place twice a week. The specification of the shame needle is the same as above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms as assessed by Patient Health Questionnaire-9（PHQ-9）	The PHQ-9 questionnaire can directly reflect the subjective feelings of depressed patients and their changes in treatment. As a severity measure, the PHQ-9 score can range from 0 to 27. since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). The higher the score, the more severe the depressive symptoms.	Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of attention network test(ANT)	Combined with spatial cue task and flanker task, Attention Network Test can effectively measure different Attention Network effects. ANT can represent three different attention networks (alertness effect, orientation effect and executive control effect).	Baseline and 6 weeks
Change of psychomotor vigilance task (PVT)	The psychomotor vigilance task (PVT) is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus. Research indicates increased sleep debt or sleep deficit correlates with deteriorated alertness, slower problem-solving, declined psycho-motor skills, and increased rate of false responding.	Baseline and 6 weeks
Change in health-related quality of life as assessed by Short Form Survey (SF-12).	This questionnaire can reflect the patients' health-related quality of life.SF-12 score ranges from 0 [lowest level of health] to 100 [highest level of health].	Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up
Change in anxiety symptoms as assessed by Generalized Anxiety Disorder Assessment (GAD-7).	This questionnaire can reflect the anxiety symptoms of patients.GAD-7 score ranges from 0 [no anxiety] to 21 [severe anxiety].	Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of Functional magnetic resonance imaging scans between two group.	Before the intervention, 40 people were randomly selected to complete the fMRI examination, and the results were compared with the normal brain database. After the intervention, all subjects underwent MR examination, and the treatment group and the control group were compared with each other. The signal of the function, gray matter fiber and white matter fiber of the dorsolateral prefrontal cortex (DLPFC) were extracted from the resting-state fMRI data. These signal will be calculated the functional network of the brain based on graph theory. Therefore, the investigator will compare the difference between two groups.	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Investigators: Study Chair: Webin Fu, MD, Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 21, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 21, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Subthreshold Depression; Needle-embedding Therapy; Executive Control System
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: YN2019ML13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No