Clinical trial NCT04319562: Needle-embedding Therapy Alleviates Depressive Symptoms and Resets the Function of Executive Control System in Subthreshold Depression People
Official title: Needle-embedding Therapy Alleviates Depressive Symptoms and Resets the Function of Executive Control System in Subthreshold Depression People: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subthreshold Depression
Keywords: Subthreshold Depression
Needle-embedding Therapy
Executive Control System
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depressive symptoms as assessed by Patient Health Questionnaire-9（PHQ-9）
timeFrame: Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up
Secondary outcomes:
measure: Change of attention network test(ANT)
timeFrame: Baseline and 6 weeks
measure: Change of psychomotor vigilance task (PVT)
timeFrame: Baseline and 6 weeks
measure: Change in health-related quality of life as assessed by Short Form Survey (SF-12).
timeFrame: Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up
measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder Assessment (GAD-7).
timeFrame: Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up
Other outcomes:
measure: Difference of Functional magnetic resonance imaging scans between two group.
timeFrame: Baseline and 6 weeks
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine)
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Webin Fu, MD
role: STUDY_CHAIR
References: