Subthreshold DepressionNCT04319562
Needle-embedding Therapy Alleviates Depressive Symptoms and Resets the Function of Executive Control System in Subthreshold Depression People
A study testing needle-embedding therapy in people with Subthreshold Depression, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Subthreshold Depression
- What is being tested?
- needle-embedding therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- patients had
- antidepressant use
- alcohol dependency
- psychosis
- recent suicidalrisk
- significant cognitive impairment
- recent bereavement
- terminal illness on clinical grounds
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine)
Guangzhou, Guangdong, 510000
Wenbin Fu, +8613808888626, fuwenbin@139.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Subthreshold Depression
- Being tested
- needle-embedding therapy, shame needle-embedding therapy
- Keywords
- Subthreshold Depression, Needle-embedding Therapy, Executive Control System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needle-embedding therapyProcedure or surgery
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).
shame needle-embedding therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| needle-embedding therapy | Experimental | The participants in this group will be treated with intradermal thumbtack needle. Receives: Procedure: needle-embedding therapy |
| shame needle-embedding therapy | Sham comparator | The participants in this group will be treated with shame intradermal thumbtack needle. Receives: Device: shame needle-embedding therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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].
Measured: 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].
Measured: Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subthreshold DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu Wenbin, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Webin Fu, MD, Study chair, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319562
- Sponsor's protocol ID
- YN2019ML13
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needle-embedding Therapy Alleviates Depressive Symptoms and Resets the Function of Executive Control System in Subthreshold Depression People: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04319562
- Acronym / sponsor ID
- YN2019ML13
- Conditions
- Subthreshold Depression
- Keywords
- Subthreshold Depression, Needle-embedding Therapy, Executive Control System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| needle-embedding therapy | Experimental | Procedure: needle-embedding therapyThe participants in this group will be treated with intradermal thumbtack needle. |
| shame needle-embedding therapy | Sham comparator | Device: shame needle-embedding therapyThe participants in this group will be treated with shame intradermal thumbtack needle. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- patients had
- antidepressant use
- alcohol dependency
- psychosis
- recent suicidalrisk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| needle-embedding therapyFirst 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). | Procedure or surgery | needle-embedding therapy |
| shame needle-embedding therapyThe 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. | Device | shame needle-embedding therapy |
Primary outcome
Change in depressive symptoms as assessed by Patient Health Questionnaire-9（PHQ-9）
Time frame: Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up
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.
4 secondary outcomes
Change of attention network test(ANT)
Time frame: Baseline and 6 weeks
Change of psychomotor vigilance task (PVT)
Time frame: Baseline and 6 weeks
Change in health-related quality of life as assessed by Short Form Survey (SF-12).
Time frame: 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).
Time frame: Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Webin Fu, MD study chair
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing needle-embedding therapy in people with Subthreshold Depression, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Fu, MD (+8613808888626, fuwenbin@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms as assessed by Patient Health Questionnaire-9（PHQ-9） (time frame: Baseline and 6 weeks, 1-, 3-, 6- and 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.