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

NCT04319562 | Unknown

• 1 other identifier: YN2019ML13
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subthreshold Depression

Keywords

Subthreshold Depression; Needle-embedding Therapy; Executive Control System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of attention network test(ANT)

  Baseline and 6 weeks

• Change of psychomotor vigilance task (PVT)

  Baseline and 6 weeks

• Change in health-related quality of life as assessed by Short Form Survey (SF-12).

  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).

  Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up

Other Outcomes (1)

• Difference of Functional magnetic resonance imaging scans between two group.

  Baseline and 6 weeks

Study Arms (2)

needle-embedding therapy

EXPERIMENTAL

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

Procedure: needle-embedding therapy

shame needle-embedding therapy

SHAM COMPARATOR

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

Device: shame needle-embedding therapy

Interventions

needle-embedding therapy PROCEDURE

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).

needle-embedding therapy

shame needle-embedding therapy DEVICE

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.

shame needle-embedding therapy

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

The Second Affiliated hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine)

Guangzhou, Guangdong, 510000, China

Location

Study Officials

• Webin Fu, MD

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Wenbin Fu, MD

CONTACT

+8613808888626; fuwenbin@139.com

Baile Ning

CONTACT

13824420916; ningbaile@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 24, 2020
• Study Start: April 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

CN (1)